RECOMMENDED INSTRUCTIONS FOR USE

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1 Rapid Exchange PTCA Dilatation Catheter RECOMMENDED INSTRUCTIONS FOR USE Available in diameters 1.25mm to 4.5mm and in lengths 09mm to 40mm Caution: This device should be used only by physicians trained in angioplasty and PTCA. This device is sterilized by Ethylene Oxide and intended for single patient use. Percutaneous Transluminal Coronary Angioplasty Catheter STIFU.D

2 DESCRIPTION The Symtrek Percutaneous Transluminal Coronary Angioplasty Catheter (PTCA) is a rapid exchange catheter for coronary angioplasty. The catheter's proximal tubing is 304V stainless steel and the distal coaxial tubings are nylon co-polymer blend. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. A second lumen at the tip is used for advancing the guidewire. The semi-compliant balloon has an average 10% growth in diameter from nominal to rated burst pressure. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon or as a single platinum band located in the centre of the working surface of the balloon. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon. Individual compliance charts are provided on each label. Please note that balloon diameters may vary within manufacturing tolerances. All inflations should be viewed under fluoroscopy. All balloons reach their nominal diameter (±0.1mm) at 6Atm. Pressures in excess of Rated Burst Pressure may cause the balloon to burst. INDICATIONS Symtrek Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. CONTRAINDICATIONS Symtrek Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter may not be used in patients with: Unprotected left main coronary artery. Coronary artery spasm in the absence of a significant stenosis. WARNINGS Use of the Symtrek in the coronary arteries requires advanced percutaneous transluminal coronary angioplasty skills. The following instructions will give technical guidance, but do not obviate the need for formal training in the use of this type of device. This device is intended for single patient use. Do NOT re-sterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of inappropriate re-sterilization and cross contamination. Page 2 of 7

3 To reduce the potential for vessel damage the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis. PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Balloon pressure should not exceed the Rated Burst Pressure. The Rated Burst Pressure is based on the results of in-vitro testing. At least 99.9 percent of the balloons, (with a 95 percent confidence) will not burst at or below their Rated Burst Pressure. Use of a pressure monitoring device is recommended to prevent over pressurization. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life threatening complication. Use only the recommend balloon inflation medium. Never use air or any gas medium to inflate the balloon. Use the catheter prior to the Use Before date specified on the package. This catheter is not intended for the delivery or expansion of stents due to the balloon being coated with a lubricious coating. PRECAUTIONS Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. During the procedure, appropriate anticoagulation by heparin administration must be provided to the patient. Coronary vasodilator therapy is usually provided to the patient. Page 3 of 7

4 POTENTIAL ADVERSE EFFECTS The following complications may occur with this device: Death Acute myocardial infarction Total occlusion of the coronary artery or bypass graph. Coronary vessel dissection, perforation, rupture or injury. Restenosis of the dilated vessel. Hemorrhage or Hematoma. Unstable Angina. Arrhythmia, including ventricular fibrillation. Drug reactions, allergic reaction to contrast media. Hypo/hypertension. Infarction. Coronary artery spasm Arteriovenous fistula. Embolism. INSTRUCTIONS FOR USE INSPECTION PRIOR TO USE: Prior to angioplasty, all equipment to be used for the procedure, including the dilatation catheter, should be carefully examined to verify proper performance. MATERIAL AND EQUIPMENT REQUIRED: QUANTITY ITEM DESCRIPTION (These materials are single-use items only) 1 Small amount of diluted contrast medium (40 % contrast medium and 60% saline). 1 Apparatus for balloon inflation. 1-2 Coronary dilatation catheter(s) selected according to the severity of the stenosis and the native vessel size. The inflated diameter of the balloon should approximate the coronary artery diameter and should never exceed the diameter of the coronary artery proximal and distal to the stenosis. In instances of severe stenosis, a smaller balloon may be needed to begin the dilatation process, which may then be replaced with a larger balloon to effect a successful dilatation. 1-2 Flexible-tipped inch (or smaller) guidewire(s). 1 Torque device for guidewire. 1 Guide wire introducer or guidewire accessory kit. 1 Flushing tool. Page 4 of 7

5 PREPARATION OF THE DILATATION CATHETER: (1) Slide the protective sheath off the balloon. (2) Prior to actual use, the balloon catheter may be tested, purged or pre-inflated (inflating to less than 5 ATMs. is suggested). If the catheter is not inflated prior to insertion into the patient, the first Inflation should not exceed 6 Atms. If the balloon is to be purged prior to insertion, the following steps are recommended: Pre-inflation could remove trifold memory. (3) To displace the air from the balloon, fill a 20 cc syringe with approximately 4 cc of 40 % contrast medium. Fill slowly so as to minimize entrapped air bubbles in the solution. Hold the syringe tip upward and expel all air. (4) Connect the 20 cc syringe with contrast solution to the balloon inflation port. Evacuate the air from the balloon by pointing the syringe tip downward and withdrawing the plunger. Hold the catheter with the distal tip and balloon pointing downward and slowly release the plunger to infuse contrast medium into the balloon. Repeat the aspiration/infusion cycle until the balloon appears adequately filled with contrast medium. Manipulation of the balloon orientation may be required to vent remaining air. Do not flick or tap the balloon. (5) If the catheter was tested, purged or pre- inflated, re-wrapping the balloon is recommended prior to insertion. To re-wrap the balloon, retract the plunger and lock or close the stopcock on the inflation device to fully deflate the balloon. Wet the balloon with saline and butterfly or 'C' fold or trifold the balloon. (6) Reinserting the balloon into the protective sheath may damage the balloon or catheter. RECOMMENDED PROCEDURE AND TECHNIQUE: (1) Attach a haemostatic valve to the appropriate guiding catheter, which has been previously inserted into the vasculature following standard product guidelines. (2) Insert the guidewire (0.014 max) into the guiding catheter through the haemostatic valve. Under fluoroscopy, position the guidewire just past the tip of the guiding catheter or across the lesion in accordance with accepted PTCA techniques. (3) Remove the protective sheath from the dilation catheter balloon. Back load the guidewire into the distal tip of the dilation catheter, ensuring that the guidewire exits the opening about 30cm proximal to the dilation catheter tip. (4) Advance the dilation catheter in small steps to the tip of the guiding catheter. (5) Re-attach the torque device to the guidewire. Hold the guidewire stationary and advance the balloon catheter over the guidewire and across the stenosis. The radio-opaque balloon marker and a low pressure (10 to 20 psi) balloon inflation should be used to confirm that the Page 5 of 7

6 indentation caused by the stenosis is centrally located within the balloon segment before proceeding with the dilation. Never advance the balloon catheter against resistance, without first identifying the resistance and taking the necessary remedial action. (6) Inflate and deflate the balloon manually by advancing and retracting the plunger of the inflation device. Maintain vacuum on the balloon between dilations by withdrawing the plunger of the inflation device. (7) After each inflation, assess run-off by angiography through the guiding catheter while the inflated balloon remains within or proximal to the stenosis. (8) To exchange catheters, maintain the guidewire s position and loosen the Haemostatic valve. Pull out the dilation catheter until the guidewire entry point exits the Haemostatic valve. Grasp the wire a short distance from the entry point and continue to withdraw the catheter. Continue to alternate grasping the guidewire and moving the catheter until the catheter tip clears the Haemostatic valve. Insert the new catheter as previously described for the initial catheter. (9) Adequacy of the angioplasty treatment is assessed by coronary angiography. The final evaluation is by angiography after the removal of the balloon catheters and guidewire. (10) Simultaneously withdraw the dilation catheter and guidewire form the guiding catheter. Withdraw the guiding catheter from the vessel. Follow standard practice for the management of the sheaths (removal should not be attempted before near normalization of clotting). PRODUCT WARRANTY We warrant that at the time of manufacture, these products were prepared and tested to verify that they are true to labeled claims. Due to biological differences in individuals, no product is 100% effective under all circumstances. In addition, because we have no control of the condition under which these products are used, diagnosis of the patient, the method of use or administration, and handling of the products after they leave our possession, we do not warrant for either a good effect or against ill effect following/during the use of the product. THE FOREGOING WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES EITHER WRITTEN, ORAL OR IMPLIED (INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PURPOSE). No representative of the company may change any of the foregoing and the buyer accepts the product subject to all terms hereof. Page 6 of 7

7 SYMBOLS USE BY Batch Code Date of Manufacture DO NOT REUSE EC Authorized Representative Catalog Number Sterilization Nominal Pressure Manufacturer Store in Cool Temperature See Instructions for Use Rated Burst Pressure Balloon Length Balloon Diameter West 8 th Avenue Vancouver, BC, V6H 1C3 CANADA Tel: Fax: URL: Page 7 of 7

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