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Warnings: FloSeal Matrix Adverse Events: Equivalence of Bovine and Human Thrombin: Time to Hemostasis FloSeal Hemostatic Matrix • FloSeal Matrix contains Thrombin made from In a randomized prospective, concurrently controlled The performance of FloSeal Matrix containing human First Lesion Only (Protocol Valid Lesions) Instructions for Use human plasma. Products made from human clinical trial using a formulation of FloSeal Matrix con- thrombin was compared to that of original FloSeal (con- Median Time to plasma may contain infectious agents, such as taining bovine thrombin, (FloSeal), a total of 309 taining bovine thrombin) in a bleeding liver square Hemostasis in minutes Caution: Federal Law restricts this device to sale by or (95% Confidence Interval*) viruses, that can cause disease. The risk that such patients received FloSeal or the Control (Gelatin model in pigs. on the order of a physician (or properly licensed practi- products will transmit an infectious agent has Sponge + Thrombin). The most common adverse events Blood flow rates for the lesions created in the pig liver Patient Category FloSeal Control tioner). been reduced by screening plasma donors for prior recorded during and after the application of the hemo- model were recorded at specific time points and sta- DO NOT INJECT. exposure to certain viruses, by testing for the static agents were anemia, atrial fibrillation, infection, All Patients 2.0 (1.5, 2.5) 6.0 (5.5, 6.0) tisitically analyzed by the method of Blackwelder and FloSeal Hemostatic Matrix (“FloSeal Matrix”) must not presence of certain current virus infections, and by and hemorrhage. The following is a complete list of Chang modified for continuous variables. This analysis Cardiac 2.8 (2.0, 4.0) 8.0 (6.0, 8.5) be injected into blood vessels. inactivating and removing certain viruses. Despite adverse events reported in greater than 1% of patients demonstrates that the performance of FloSeal Matrix is Vascular 2.5 (2.0, 4.0) 6.5 (4.5, 8.0) these measures, such products can still potentially that were observed in the pivotal clinical trial for the equivalent to the performance of FloSeal with a p-value Device Description: Spinal/Orthopedic 1.5 (1.0, 1.5) 3.0 (2.0, 4.5) transmit disease. Because this product is made FloSeal group. The corresponding adverse events for of < 0.001 at each of the time intervals. FloSeal Matrix consists of a bovine-derived Gelatin from human blood, it may carry a risk of the Control group are listed for comparison. None of In addition, each lesion was subjectively scored for *Confidence interval using a Bonferroni correction. Matrix component, a human-derived Thrombin compo- transmitting infectious agents, e.g., viruses, and the adverse events that occurred were judged by the nent, applicator tips, and several mixing accessories. theoretically, the Creutzfeldt-Jakob disease (CJD) surgeon to be “Probably Related” to the use of FloSeal. bleeding at each time point. These data were analyzed Use of FloSeal as a Hemostatic Agent The mixing accessories include a syringe with an integral agent. ALL infections thought by a physician using the method of Blackwelder and Chang for propor- for Nasal/Sinus Bleeding: female Luer connector, a small bowl, and a 5 mL syringe possibly to have been transmitted by this product tions. The results for all lesions in all animals showed Adverse Events Reported in Greater than 1% of FloSeal Matrix and FloSeal were equivalent for each of FloSeal has been used as a hemostatic agent for the with needle attached. The mixing accessories are should be reported by the physician or other Patients in the FloSeal Clinical Trial Patients the time intervals with a p-value of 0.015. control of operative and post-operative bleeding (epis- included to facilitate the reconstitution and mixing of the healthcare provider to Baxter Healthcare taxis) during nasal/sinus surgery in 18 patients (30 Thrombin into the Gelatin Matrix. Applicator tips are Corporation. The physician should discuss the risks Control Clinical Studies: application sites). Patients were followed for 24 hours included to facilitate the delivery of FloSeal Matrix to the and benefits of this product with the patient. Adverse Event FloSeal (Gelatin Sponge following surgery and all complications and episodes of site to be treated. (For specific package contents, see + Thrombin) Study Design and Objectives: A prospective, ran- • FloSeal Matrix is not intended as a substitute for epistaxis were recorded during this period. Table in “How Supplied” section.) domized, controlled, multi-center, multi-specialty study meticulous surgical technique and the proper Intraoperative bleeding stopped in 30 of 30 (100%) application of ligatures or other conventional Anemia 12 (8%) 7 (4%) was conducted using a formulation of FloSeal Matrix application sites. No intraoperative complications were The Gelatin Matrix consists of crosslinked gelatin gran- procedures for hemostasis. FloSeal Matrix is containing bovine thrombin, (FloSeal). Three hundred reported in this group. One patient presented with ules and is provided sterile and non-pyrogenic in a Fibrillation Atrial 10 (6%) 8 (5%) effective on surgical bleeding, from oozing to and nine (309) patients were enrolled at 10 centers. epistaxis 6 hours postoperatively; this patient was standard disposable syringe. The Thrombin (Human) is Infection 10 (6%) 11 (7%) spurting, and is not intended to be used as a The objective of the study was to evaluate the safety treated uneventfully and released from the hospital on a sterile, non-pyrogenic, freeze-dried, vapor-heated prophylactic hemostatic agent. Hemorrhage 6 (4%) 6 (4%) and effectiveness of FloSeal, compared to a commer- the first postoperative day. powder preparation made from pooled human plasma. cially available control hemostat, Absorbable Gelatin The Calcium Chloride Solution is a sterile, non-pyro- • FloSeal Matrix should not be used in the presence Pneumonia 6 (4%) 2 (1%) Sponge, USP (“Gelatin Sponge”) + Thrombin, in control- How Supplied: genic solution. After reconstitution of the lyophilized of infection. FloSeal Matrix should be used with Urinary Tract Infection 6 (4%) 3 (2%) ling intraoperative bleeding. This study was designed Thrombin in Calcium Chloride Solution, the resulting caution in contaminated areas of the body. If FloSeal Matrix is provided in the configuration shown Rash 5 (3%) 3 (2%) to show that the FloSeal success rate was equivalent thrombin solution contains 500 I.U./mL Thrombin signs of infection or abscess develop where in the table below. to the success rate for the Control. Patients undergoing (Human). FloSeal Matrix has been applied, reoperation may Edema 5 (3%) 1 (<1%) surgery in cardiac, vascular or spinal/orthopedic surgi- be necessary in order to remove the infected Hypotension 4 (3%) 2 (1%) cal specialties were included. Source Plasma obtained from US licensed plasma col- material and allow drainage. lection centers is used to produce FEIBA bulk powder, Respiratory Distress 4 (3%) 3 (2%) FloSeal Hemostatic Matrix Configuration • Regardless of the type of surgical procedure, Patients were randomized only after it was determined the starting material of Thrombin. (Final product, FEIBA Confusion 4 (3%) 0 (0%) Gelatin Matrix Thrombin Component surgeons should consider the maximum swell that the bleeding could not be controlled using conven- VH Anti-Inhibitor Coagulant Complex, which is manu- Component volume of approximately 20% of FloSeal Matrix Dural Tear 4 (3%) 4 (3%) tional approaches (e.g. direct pressure, sutures and/or factured by Baxter Healthcare Corporation from the • 1 x 5 mL syringe after product is applied and its potential effect on cautery) because of their ineffectiveness or impractical- • 1 x vial Thrombin same bulk, is licensed and distributed in the US for the Fibrillation Ventricular 4 (3%) 3 (2%) ity. Success at achieving hemostasis was defined as with Gelatin Matrix (Human) containing: control of spontaneous bleeding episodes or to cover the surrounding anatomic areas. Maximum swell Arrhythmia 4 (3%) 0 (0%) cessation of bleeding within 10 minutes following surgical interventions in hemophilia A and B patients volume is achieved within about 10 minutes. • 1 x 5 mL syringe with • 2500 IU thrombin Heart Failure Right 3 (2%) 2 (1%) application of the agent. The primary endpoint was integral female Luer with inhibitors.) Thrombin is prepared by dissolving • Excess FloSeal Matrix (material not incorporated • 225-275 mg total hemostasis success for the first treated bleeding site. A connector FEIBA bulk powder and incubating the solution with in the hemostatic clot) should be removed by Thrombosis Arterial 3 (2%) 8 (5%) secondary endpoint was time to hemostasis for the first protein calcium chloride in order to activate prothromin to gentle irrigation from the site of application, Fever 3 (2%) 2 (1%) • 1 x bowl for Thrombin treated bleeding site. Although multiple bleeding sites • 40-60 mg sodium thrombin. After several filtration steps, the final bulk particularly when used in, around, or in proximity • Applicator tips (2) Atelectasis 3 (2%) 1 (<1%) in the same patient were treated, only the first treated chloride solution is freeze-dried. The Calcium Chloride Solution to foramina in bone, areas of bony confine, the bleeding site was used to determine primary effective- is prepared from calcium chloride complying with the spinal cord, and/or the optic nerve and chiasm. Pleural Effusion 3 (2%) 5 (3%) • 12-18 mg glycine ness, as this was the only site that was truly random- specifications listed in the US Pharmacopeia. Counts reflect number of patients in each treatment • 1 x vial Calcium Chloride • The safety and effectiveness of FloSeal Matrix for ized. use in ophthalmic procedures has not been group reporting one or more adverse events that map to Solution, 5 mL Thrombin is made from pooled human plasma. The established. a Modified COSTART 5 th edition body system. At each Clinical Study Results: two-step vapor heat treatment used in its manufacture • 200 mol CaCl2 level of summarization (Adverse Event), patients are has been shown to be capable of significant viral • FloSeal Matrix should not be used for controlling Primary Endpoint: The primary endpoint, cessation of • 1 x 5 mL syringe with only counted once. reduction. However, no procedure has been shown to post-partum bleeding or menorrhagia. bleeding within 10 minutes of the first lesion, achieved needle attached be completely effective in removing viral infectivity a success rate of 96% in the FloSeal group and 77% in • The safety and effectiveness of FloSeal Matrix has from derivatives of human plasma (see Warnings). Other adverse events observed in 1% or less of the the Control group. Treatment and Control were shown not been established in children and pregnant women. FloSeal clinical trial patients were myocardial infarc- to be equivalent using the Blackwelder and Chang test, The package also includes this FloSeal Hemostatic The manufacturing procedure for FloSeal Matrix tion, cellulitis, pneumothorax, pain, cerebrovascular using a (clinically significant difference) of 0.15 Matrix Instructions for Use. includes processing steps designed to reduce the risk Precautions: accident, hallucination, paresthesia, bradycardia, (p<0.0001). The difference between Treatment and of viral transmission. Several steps are included in the abscess, diarrhea, urinary retention, dehiscence, skin Control was also shown to be statistically significant manufacture of the Gelatin Matrix component that General ulcer, transfusion reaction, dyspnea, heart arrest, lung using the Cochran-Mantel-Haenszel test (p<0.001). reduce the risk of viral transmission. The virus reduc- edema, back pain, ventricular tachycardia, neuropathy, tion factors (expressed as log10) for the manufacture of • For single use only. Do not resterilize. Primary endpoint data were stratified for individual sur- acute kidney failure, kidney tubule necrosis, gastritis, the Gelatin Matrix component are provided in the table gical specialties, and the results are summarized in the • Since the Thrombin Solution can be denatured by nausea, nausea and vomiting, skin rash, hyperglycemia, below. table below: contact with solutions containing alcohol, iodine, and heel ulcer. Reduction Factors for Virus Removal and/or or heavy metal ions, FloSeal Matrix should not be Hemostasis within 10 minutes – First Lesion Only The following adverse events, all rated “mild”, were Inactivation during the Manufacture of Gelatin applied before the application site is cleaned to (Intent-to-Treat Patients) deemed by the surgeon to be “Possibly Related” to the Matrix remove any antiseptics that may contain such use of FloSeal: anemia (2 patients, 1%), mild post-oper- Patient Category FloSeal Control substances. Virus Reduction Factor ative bleeding (1 patient, <1%), and local inflammation of Virus Tested • When placed into cavities or closed tissue spaces, All Patients 96% (149/156) 77% (118/153) (1 patient, <1%). No other adverse events were Manufacturing Step BVDV PPV gentle approximation is advised. When applied to deemed by the surgeon to be related to the use of Cardiac 94% (45/48) 60% (27/45) a bleeding site, the particles of FloSeal Matrix FloSeal. Vascular 93% (40/43) 76% (35/46) Base Treatment (NaOH) >5.42 3.99 swell approximately 20% upon contact with blood Allergic reactions may be encountered in people known Spinal/Orthopedic 98% (64/65) 90% (56/62) or other fluids. Maximum swell volume is Chemical Cross-linking >4.96 1.06 to be sensitive to bovine materials. achieved within about 10 minutes. Heat Treatment >6.46 1.87 In the cardiac cohort, 88 of the 93 patients (95%) • As with other hemostatic agents, do not aspirate Gelatin-Based Hemostatic Agents: underwent surgery with extracorporeal cardiopulmonary FloSeal Matrix into extracorporeal Reported Adverse Events: bypass. FloSeal was used for hemostasis prior to cardiopulmonary bypass circuits or autologous A two-step vapor heating process is included in the • Gelatin-based hemostatic agents may serve as a heparin reversal by the administration of protamine sul- blood salvage circuits. It has been demonstrated manufacture of Thrombin. The virus reduction factors nidus for infection and abscess formation and fate in 19 of 46 patients. Protamine sulfate reverses that fragments of collagen based hemostatic (expressed as log10 ) for Thrombin are provided in the have been reported to potentiate bacterial growth. the anticoagulative effects of heparin. Results for agents may pass through 40 transfusion filters table below. • Giant cell granulomas have been observed at hemostasis at 10 minutes for the heparinized patients of blood scavenging systems. implant sites when used in the brain. in both the FloSeal and Control groups, before and after • FloSeal Matrix should not be used in conjunction protamine sulfate reversal of heparin, are shown in the Reduction Factors for Virus Removal and/or with methylmethacrylate or other acrylic • Compression of the brain and spinal cord resulting Inactivation during the Manufacture of table below: adhesives. Microfibrillar collagen has been from the accumulation of sterile fluid has been Thrombin (Human) reported to reduce the strength of observed. Hemostasis Success at 10 Minutes Before and Manufacturing Step Virus Reduction methylmethacrylate adhesives used to attach • Multiple neurologic events were reported when Factor of Virus Tested After Protamine Administration prosthetic devices to bone surfaces. absorbable gelatin-based hemostatic agents were (Cardiac Patients Only) HIV-1 TBEV PRV ERV-1 HAV • FloSeal Matrix should not be used for the primary used in laminectomy operations, including cauda equina syndrome, spinal stenosis, meningitis, Group Before Protamine After Protamine Cryoprecipitation 1.4 ≤ 1.0 1.1 ≤ 1.0 n.d. treatment of coagulation disorders. arachnoiditis, headaches, paresthesias, pain, FloSeal 89% (17/19) 96% (26/27) Adsorption on • The safety and effectiveness of the combined use bladder and bowel dysfunction, and impotence. DEAE-Sephadex 2.0 3.0 3.1 ≤ 1.0 n.d. of FloSeal Matrix with antibiotic solutions or Control 36% (5/14) 75% (21/28) powders has not been established. • The use of absorbable gelatin-based hemostatic Freeze-Drying 2.0 ≤ 1.0 2.6 1.9 2.7 agents during the repair of dural defects • The safety and effectiveness for use in The success rate for FloSeal did not appear to be Vapor Heating >4.6 >7.0 >4.8 >4.7 >3.9 associated with laminectomy and craniotomy neurosurgical and urological procedures has not affected by whether or not the patient had received n. d. = not determined operations, has been associated with fever, been established through randomized clinical protamine sulfate administration. This was demon- infection, leg paresthesias, neck and back pain, FloSeal Matrix is the combination of the Gelatin Matrix study. strated by the fact that the success rate for FloSeal bladder and bowel incontinence, cauda equina component and the reconstituted Thrombin (Human) • In urological procedures, FloSeal Matrix should not syndrome, neurogenic bladder, impotence, and before protamine sulfate administration was similar to component. Thrombin must be added to the Gelatin be left in the renal pelvis or ureters to eliminate paresis. the success rate after protamine sulfate administration Matrix component prior to use. FloSeal Matrix is bio- the potential foci for calculus formation. whereas the Control hemostat success rate was clearly compatible and resorbed within 6 to 8 weeks, consis- • The use of absorbable gelatin-based hemostatic lower before protamine sulfate reversal of heparin was tent with normal wound healing. FloSeal Matrix is agents has been associated with paralysis, due to Information for Patients administered. intended only for topical administration. device migration into foramina in the bone around • Some viruses, such as parvovirus B 19, are the spinal cord, and blindness, due to device Secondary Endpoint: A secondary endpoint was time Indications: particularly difficult to remove or inactivate at this migration in the orbit of the eye, during lobectomy, to hemostasis for the first treated bleeding site. The time. Parvovirus B 19 most seriously affects laminectomy and repair of a frontal skull fracture data for time to hemostasis are summarized in the FloSeal Matrix is indicated in surgical procedures (other pregnant women, or immune-compromised and lacerated lobe. table below. than in ophthalmic) as an adjunct to hemostasis when individuals. Symptoms of parvovirus B 19 control of bleeding by ligature or conventional proce- • Foreign body reactions, “encapsulation” of fluid, infection include fever, drowsiness, chills, and dures is ineffective or impractical. and hematoma have been observed at implant Cumulative Percent of Patients with Complete runny nose followed about two weeks later by a sites. Hemostasis First Lesion (Protocol Valid Patients*) rash, and joint pain. Patients should be Contraindications: • Excessive fibrosis and prolonged fixation of a encouraged to consult their physician if such Time Interval FloSeal Control • Do not inject or compress FloSeal Matrix into symptoms appear. tendon have been reported when absorbable 0 – 1 minute 41% (62/153) 21% (32/150) blood vessels. Do not apply FloSeal Matrix in the gelatin-based sponges were used in severed absence of active blood flow, eg., to clamped or tendon repair. 1 – 2 minutes 69% (106/153) 32% (48/150) Carcinogenesis, Mutagenesis, Impairment of Fertility bypassed vessels. Extensive intravascular clotting • Toxic shock syndrome was reported in association 2 – 3 minutes 85% (130/153) 48% (72/150) • Long-term animal studies to evaluate the and even death may result. with the use of absorbable gelatin-based carcinogenic potential of FloSeal Matrix or studies 3 – 6 minutes 93% (143/153) 68%(102/150) • To avoid a risk of allergic-anaphylactoid reaction to determine the effect of FloSeal Matrix on hemostats in nasal surgery. 6 – 10 minutes 97% (149/153) 77% (115/150) and/or thromboembolic events, which may be life- fertility have not been performed. • Fever, failure of absorption, and hearing loss have threatening, do not inject FloSeal Matrix into a *Six (6) patients, 3 in the FloSeal group and 3 in the been observed when absorbable hemostatic vessel or tissue. Control group, were excluded because of protocol devi- Pregnancy Category C agents were used during tympanoplasty. ations in measuring hemostasis for the first treated • Do not use FloSeal Matrix in the closure of skin • It is not known whether FloSeal Matrix can cause Adverse Reactions to Human Thrombin: bleeding site. incisions because it may interfere with the healing fetal harm when administered to a pregnant of the skin edges due to mechanical interposition woman or can affect reproduction capacity. As with any other plasma derivatives, anaphylactoid or of gelatin. FloSeal Matrix should be administered to a anaphylactic reactions may occur in rare cases. No When the data were stratified by surgical specialty, the • Do not use FloSeal Matrix in patients with known pregnant woman only if clearly needed. adverse events of this type were reported during the median times to hemostasis were shorter for the allergies to materials of bovine origin. course of clinical trials using a different product con- FloSeal group than for the Control group in all special- taining the same human thrombin component. Mild ties. The median times are summarized in the table reactions can be managed with antihistamines; severe below. hypotensive reactions require immediate intervention using current principles of shock therapy. Directions for Use: • To minimize disruption of the clot, remove gauze sponges after hemostasis has been achieved. If Thrombin must be added to the Gelatin Matrix prior to use. the gauze sponge adheres to the newly-formed FloSeal Matrix Preparation: clot, irrigate the sponge with non-heparinized saline and carefully remove it from the treated Inspect the integrity of the contents of the FloSeal site. Matrix package. If the packaging or vials have been • In cases of persistent bleeding, indicated by damaged or opened, do not use. saturation and bleeding through the granules, Opening the Package insert the Applicator tip through the center of the mass of previously placed FloSeal Matrix to • Open the Thrombin Component package outside deliver fresh FloSeal Matrix as close as possible the sterile field. Items in this package will be to the tissue surface. After re-application of used to reconstitute the Thrombin prior to FloSeal Matrix, resume approximation with a transferring it to the sterile field. gauze sponge for up to another two minutes, and • Open the outer package containing the Gelatin then inspect the site again. Repeat re-application Matrix Component and deliver the sterile inner if necessary. package to the sterile field. Once placed on the • Once bleeding has ceased, excess FloSeal Matrix, operating field, the inner package may be opened material not incorporated in the hemostatic clot, at any time. should be removed by gentle irrigation. Preparing the Thrombin Solution • Do not disrupt the FloSeal Matrix-clot complex by physical manipulation. FloSeal incorporated in • Remove the plastic flip-off cap from the Calcium the hemostatic clot should be left in situ. Chloride Solution vial. Remove the plastic flip-off cap from the Thrombin vial. Disinfect the rubber stoppers of both vials with a germicidal solution For Nasal/Sinus Applications: and allow to dry. Do not use iodine-containing preparations such as betadine for disinfection. For endoscopic sinus surgery and epistaxis • Using the 5 mL syringe with needle attached • Deliver FloSeal Matrix to the source of bleeding provided in the Thrombin Component package, using a non-traumatic applicator of appropriate transfer all 5 mL of Calcium Chloride Solution to length attached to the FloSeal Matrix syringe. the vial containing the lyophilized Thrombin. Keep the 5 mL syringe with needle attached in the • Apply sufficient FloSeal Matrix to liberally cover Thrombin vial. Discard the empty Calcium the entire bleeding surface. Chloride Solution vial appropriately. • Using forceps or other appropriate instrument, • Gently swirl the Thrombin vial until the Thrombin carefully layer a moistened cottonoid over the is completely dissolved. Once reconstituted, the FloSeal Matrix for 1-2 minutes to ensure the Thrombin Solution should be used promptly. material remains in contact with the bleeding However, the Solution may be used up to 4 hours tissue. In cases of persistent bleeding, indicated after reconstitution. by saturation and bleeding through the granules, insert the applicator tip through the center of the • Aspirate the Thrombin solution into the syringe. mass of previously placed FloSeal Matrix to Transfer the Thrombin solution into the sterile deliver fresh material as close as possible to the field by dispensing into the small bowl provided in tissue surface. After re-application of FloSeal the Gelatin Matrix Component package. Discard Matrix, use a moistened cottonoid to approximate both the empty Thrombin vial and 5 mL syringe the material to the tissue for another minute, and with needle attached appropriately. then inspect the site. Repeat re-application if Mixing the Thrombin Solution into the Gelatin Matrix necessary. • An empty 5 mL syringe with an integral female • Once hemostasis has been achieved, remove the Luer connector is provided with the Gelatin Matrix cottonoid Excess FloSeal Matrix should be Component. Using this syringe, aspirate the removed with gentle irrigation or careful suction. Thrombin solution from the small bowl into the Avoid disrupting the FloSeal Matrix-clot complex. syringe to the indicated mark (4 mL). • FloSeal Matrix does not have to be removed • Remove the Luer cap from the Gelatin Matrix postoperatively as it is bioresorbed. Syringe carefully to avoid spilling the Gelatin • Use of nasal packing has not been necessary Matrix granules. Connect this syringe to the when satisfactory hemostasis has been achieved syringe containing the Thrombin solution. Push with FloSeal. the plunger of the Thrombin solution syringe to • The use of FloSeal Matrix for mechanical support fully pass the solution into the syringe containing has not been studied. the Gelatin Matrix. This constitutes “one pass”. Transfer the Gelatin Matrix-Thrombin solution mixture back and forth between the syringes for a Storage Conditions: total of at least twenty passes. While starting to The FloSeal Matrix package should be stored at 2 - mix, do not try to force large, dry clumps of the 25°C (36 - 77°F). Do not freeze. Gelatin Matrix through the Luer connector, as it Manufactured by: may clog. After the first several passes, most of Baxter Healthcare Corporation the Gelatin Matrix should be hydrated, and the Fremont, CA 94555, USA contents should then be passed rapidly between Customer Service 1 800 423 2090 the syringes to promote thorough mixing. The FloSeal material should be in the FloSeal Matrix Reorder No.: 934057 (Case of 6) branded syringe at the completion of mixing. Baxter and FLOSEAL are trademarks of Baxter • Ensure the syringe labeled FloSeal contains the International Inc. FEIBA is a trademark of Baxter AG. FloSeal Matrix. Baxter, FEIBA and FLOSEAL are registered in the US Patent and Trademark Office. • If desired, connect an Applicator tip to the FloSeal Matrix syringe. FloSeal Matrix may also be Portions of this package are covered by US Patents extruded directly from the syringe. #4,640,834, #5,209,776, #5,292,362, #5,714,370, #6,063,061 and #6,066,325, European Patent No. • Product consistency may not be optimal if used EP0542880B1, and by other pending patent applica- prior to 30 seconds after preparation. tions. • FloSeal Matrix may be used up to two (2) hours after mixing with the Thrombin Solution. Label Code: 0700822 Rev: 0 Rev. Date: 03/05 • If desired, transfer FloSeal Matrix to a smaller Lit. No. 45010 syringe (e.g. 3 mL) for extrusion through longer applicator tips. Definition of Symbols: FloSeal Matrix Placement/Application: Do not inject FloSeal Matrix into blood vessels. See Attention, see instructions for use the Contraindications, Warnings, Precautions, and Adverse Events sections contained in these Instructions Do not reuse for Use. For best results, FloSeal Matrix should be in complete Sterile contact with the actively bleeding tissue surface. The particles of FloSeal Matrix swell approximately Sterilized using irradiation 20% upon contact with blood or other fluids. Maximum swell volume is achieved within about 10 minutes. LATEX Latex-free Application Technique Mix thrombin solution • Identify the source of bleeding at the tissue surface. This is the target site for FloSeal Matrix application. Swoosh gelatin: Mix thrombin • Manually approximate a gauze sponge moistened solution with Gelatin with sterile (non-heparinized) saline against the bleeding surface and use the Applicator tip (or syringe tip) to dispense FloSeal Matrix between Apply FloSeal the sponge and the bleeding surface. The gauze sponge will hold FloSeal Matrix in place against the bleeding surface in the presence of active bleeding. Apply enough FloSeal Matrix to create a small “mound” of material at the source of bleeding. • For tissue defects (“divots” or “craters”), begin applying FloSeal Matrix at the deepest part of the lesion, and continue applying material as the syringe (or Applicator tip, if used) is withdrawn from the lesion. This “back-filling” action will ensure that FloSeal Matrix comes into contact with the entire bleeding surface at the tissue defect. • Apply a gauze sponge to approximate the FloSeal Matrix against the bleeding surface, conforming it to the lesion. • After approximately two minutes, lift the gauze sponge and inspect the wound site. If bleeding has ceased, excess FloSeal Matrix (not incorporated in the hemostatic clot) should be removed by gentle irrigation.
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