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IFU for Bioglue Surgical Adhesive (Outside USA)

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IFU for Bioglue Surgical Adhesive (Outside USA) Instructions for Use Syringe BioGlue® Adhésif BioGlue® Collante Chirurgico Adhesivo Quirúrgico Chirurgical Mode Chirurgischer Klebstoff BioGlue® Istruzioni d’uso BioGlue® Instrucciones d’emploi Seringue Gebrauchsanwei sung Siringa de Uso Jeringuilla Spritze BioGlue® Adesivo BioGlue® Kirurgisk BioGlue® Kirurgisk Lim BioGlue® Vävnadslim Cirúrgico Instruções de Klæbemiddel Bruksanvisning Sprøyte Bruksanvisning Spruta Utilização Seringa Brugsanvisning Sprøjte Χειρουργική συγκολλητική BioGlue® Cerrahi Chirurgické adhezivum BioGlue® ουσία BioGlue® Οδηγίες Yapışkan Kullanım BioGlue® Návod k použití Chirurgische Kleefstof χρήσης Σύριγγα Talimatları Şırınga Stříkačka Gebruiksinstructies Spuit Chirurgické Lepidlo BioGlue® Sebészi Klej Chirurgiczny Хирургический клей BioGlue® Návod na Szövetragasztó BioGlue® Sposób Użycia BioGlue® Инструкция по Použitie Striekačka Használati útmutató Strzykawka применению Шприц Fecskendő CryoLife, Inc. 1655 Roberts Boulevard, NW • Kennesaw, Georgia 30144 • USA • +1 (770) 419-3355 • Fax +1 (770) 590-3753 http://www.cryolife.com 25°C 0°C L6313.009 Rev (07/2010) ENGLISH PRODUCT DESCRIPTION BioGlue® Surgical Adhesive is composed of bovine serum albumin and glutaraldehyde. The product’s two components are mixed within the applicator tip of the syringe during application to tissue. Polymerization of the surgical adhesive begins immediately upon application, reaching bonding strength within 2 minutes. INDICATIONS • Do not peel away BioGlue from an unintended site, as 3. While firmly grasping the syringe, nose upward, BioGlue Surgical Adhesive is indicated for use as an this could result in tissue damage. turn the cap 90° counterclockwise and remove the adjunct to standard methods of surgical repair (such • An animal study12 has shown that the circumferential cap by rocking it from side-to-side. Align the tip with as sutures, staples, electrocautery, and/or patches) to application of BioGlue restricts dilatation on growing the syringe using the corresponding notches on bond, seal, and/or reinforce soft tissue. BioGlue may tissue. These findings suggest caution with the each and place the tip on the syringe. also be applied alone to seal and/or reinforce damaged circumferential use of BioGlue in children. parenchyma when other ligature or conventional • Do not implant BioGlue into closed anatomic locations procedures are ineffective or impractical. Indicated soft that are in immediate proximity to nerve structures. tissues are cardiac, vascular, pulmonary, genitourinary, • Due to clinical reports19 of ineffective sealing when dural, alimentary (esophageal, gastrointestinal, and BioGlue is used in the translabyrinthine approach for colorectal), and other abdominal (pancreatic, splenic, acoustic neuroma repairs, its use with this surgical hepatic, and biliary). Additionally, BioGlue is used in the fixation of surgical meshes in hernia repair. approach is not recommended. Successful use of the product using the middle fossa or retrosigmoid CONTRAINDICATIONS approach for acoustic neuroma repair has been Figure 3 BioGlue is contraindicated for use in cerebrovascular 7 described in the literature and is recommended. CAUTION: Take care not to spill solution from the repairs and any intra-luminal areas. BioGlue is not for • Published human clinical data has shown that syringe during assembly. patients with known sensitivity to materials of bovine excessive application of BioGlue in lung surgery can origin. 4. Lock the applicator tip in place by pushing the tip cause residual air space and atelectasis.17 firmly toward the syringe and rotating the tip collar WARNINGS ADVERSE INCIDENTS • Do not use BioGlue as a substitute for sutures or 90° clockwise. Knowledge of all possible complications of soft tissue staples in tissue approximations. • Do not use BioGlue in a manner that would contact repair surgery is necessary for physicians performing or obstruct circulating blood flow during or after these procedures. Complications specific to these application. BioGlue entering the circulation can result types of surgeries may occur at any time during or after in local or embolic vascular obstruction. the procedure. • Do not use BioGlue in a manner that would obstruct Complications specific to the adjunctive use circulating air or other luminal fluid flow during or after of BioGlue Surgical Adhesive during soft tissue application. repair surgery may include, but are not limited to, Figure 4 • Avoid contact with nerves, eyes, or other tissue not the following: failure of product to adhere to tissue, intended for application. application of adhesive to tissue not targeted for 5. While keeping the syringe upright, align the • An animal study10 has shown that direct application procedure, inflammatory and immune response, small and large barrels of the syringe with the of BioGlue to the exposed phrenic nerve can cause allergic reaction, mineralization of tissue, local tissue corresponding syringe plunger heads and slide acute nerve injury. A separate animal study11 has necrosis, vessel obstruction, bronchial or luminal the plunger into the back of the syringe until shown that direct application of BioGlue to the obstruction, thrombosis and thromboembolism, resistance is felt. The syringe delivery device is surface of the sinoatrial node (SAN) of the heart pulmonary emboli, injury to normal vessels or tissue, now assembled. can cause coagulation necrosis that extends into and possible transmission of infectious agents from the myocardium, which could reach underlying material of animal origin. conduction tissue and may cause acute, focal SAN degeneration. Subsequent animal studies13,14 have PACKAGING AND STORAGE demonstrated that chlorhexidine gluconate gel The BioGlue syringe and applicator tips are supplied (e.g., Surgilube®) can protect the phrenic nerve, the sterile for single-patient use only. Discard any unused myocardium, and the underlying SAN from potential material from opened or damaged product. injury from BioGlue use. The BioGlue solutions are contained within • Do not use BioGlue if staff is not adequately protected a capped, double-chambered sterile syringe. Figure 5 (e.g., wearing gloves, mask, protective clothing, Polymerized BioGlue is non-pyrogenic. Store below CAUTION: Do not lay the assembled device on its side and safety glasses). Unreacted glutaraldehyde may 25°C, but do not freeze. until all air has been purged (see next paragraph). cause irritation to eye, nose, throat, or skin; induce respiratory distress; and cause local tissue necrosis. DIRECTIONS FOR USE CAUTION: Before using BioGlue in the procedure, Prolonged exposure to unreacted glutaraldehyde may Apply BioGlue Surgical Adhesive prophylactically or the syringe must be purged of the residual air space cause central nervous system or cardiac pathology. If after a leak is detected. and the applicator tip must be primed. Refer to contact occurs, flush affected areas immediately with Device Preparation Site Preparation, Syringe Air Space Removal and water and seek medical attention. The BioGlue Surgical Adhesive Syringe delivery Applicator Tip Priming. • Do not use BioGlue in the presence of infection and system consists of: syringe, syringe plunger and use with caution in contaminated areas of the body. 6. If using an applicator tip with a flexible extension, applicator tip. • Exercise caution with repeat exposure of BioGlue a desired angle may be created by bending the Inside the BioGlue Syringe box there are two in the same patient. Hypersensitivity reactions are extension at the appropriate location to the desired possible upon exposure to BioGlue. Sensitization has separate pouches. One contains the syringe and the angle and holding for 3-5 seconds. The angle been observed in animals. syringe plunger and one contains four applicator tips. created should be maintained for up to 5 minutes. The 10mL BioGlue Syringe box includes an • BioGlue contains a material of animal origin, which 7. To remove occluded applicator tips, grasp may be capable of transmitting infectious agents. additional pouch containing three, 12mm Spreader Tips. the applicator tip collar, rotate the tip collar PRECAUTIONS counterclockwise, and lift the tip off the syringe by • It is recommended that surgical gloves, sterile 1. Remove the syringe, syringe plunger, and rocking it side to side. gauze pads/towels, and surgical instruments be applicator tips from their packaging. While holding maintained moist to minimize the potential for BioGlue the syringe upright, tap the syringe until the air Site Preparation, Syringe Air Space Removal and inadvertently adhering to these surfaces. bubbles in the solutions rise to the top of the Applicator Tip Priming • BioGlue syringe, applicator tips, and applicator tip syringe. 1. The target surgical field must be properly prepared extenders are for single patient use only. Do not prior to either removal of the residual air space, re-sterilize. priming, or applying BioGlue. BioGlue works best • Do not use if packages have been opened or when the target surgical field is dry. A dry surgical damaged. field can be described as a field that does not • Take care not to spill contents of the syringe. restain with blood within 4-5 seconds after wiping • Do not compress the syringe plunger while attaching dry with a surgical sponge. it to the syringe. • Do not apply BioGlue in a surgical field that is too wet. CAUTION: Do not attempt to apply BioGlue to a field This may result in poor adherence. Figure 1 that is too wet. Application of BioGlue into a
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