ASAHI Masters PARKWAY HF KIT

Transcription

1 ASAHI Masters PARKWAY HF KIT Guide Wire Pre-loaded Microcatheter SYMBOLS 1 English 2 AMK-DT202 Ver.1.30 / 11TS023

2 SYMBOLS Legal manufacturer GC Minimum guiding catheter I.D. Do not use if package is damaged Maximum injection pressure Do not reuse Guide wire O.D. Do not resterilize Contents Contents Caution, consult accompanying documents 1 Unit Use by STRAIGHT Distal end shape of microcatheter (straight) Keep dry Distal end shape of guide wire (multi curve) Keep away from sunlight Distal end shape of guide wire (angled) EC REP Authorized representative in the European Community Guide wire LOT LOT number Strainer REF Catalogue number Torque device STERILE EO Sterilized using ethylene oxide Stylet Consult instructions for use Microcatheter Microcatheter I.D. 1

3 EN ASAHI Masters PARKWAY HF KIT Guide Wire Pre-loaded Microcatheter INSTRUCTIONS FOR USE Read these instructions before using this device and observe the Indications for Use, Contraindications, Warnings, Precautions, Malfunction and Adverse effects, How to Use, sections in the Instructions for Use. Failure to do so may result in complications, including serious injury to the patient or death. These Instructions for Use apply to the ASAHI Masters PARKWAY HF KIT Guide Wire Pre-loaded Microcatheter. For details of the respective product, refer to the product label. Descriptions This product is a combination of a microcatheter and a guide wire. The microcatheter is preloaded with the guide wire and ready for use. The attached torque device with flush function can be used to flush the lumen of the microcatheter from the back end of the torque device. The outer surface of the microcatheter is coated with hydrophilic polymer in order to exert the lubricity when wet. Its lumen excluding the connector section is coated with PTFE to facilitate the movement of the guide wire and other devices. The entire shaft has a radiopaque structure, and the tip of the distal end has a radiopaque marker for clear identification. The guide wire is coated with a plastic polymer containing radiopaque material, and with hydrophilic polymer in order to exert the lubricity when wet. Shape and structure Tip Shaft Protector Marker Connector Guide wire 2

4 Specifications Table 1 Specifications of ASAHI Masters PARKWAY HF KIT Microcatheter O.D. (Distal/Proximal) 0.88mm/0.93mm (2.6 Fr./2.8 Fr.) Microcatheter I.D mm (0.027 ) Guide wire O.D mm (0.021 ) Minimum guiding catheter I.D mm (0.041 ) Maximum injection pressure 6895 kpa (1000 psi) This microcatheter can cope with the maximum pressure of 6895 kpa (1000 psi) when the distal end is open. Indications for Use This product is medical device intended for superselective angiography and/or infusion of various substances including diagnosis, embolization and treatment in peripheral vessels using an appropriate guiding catheter. Do not use this product in the neuro and/or coronary vasculature. Contraindications Do not use this product for patients in pregnancy or patients who may be pregnant (X-ray may affect the unborn child). Warnings Failure to observe the following may result in life-threatening adverse effects. This product is presterilized with ethylene oxide gas (EOG) and is intended for single use only. Do not reuse or resterilize. If the package is opened or damaged, do not use this product. Do not open the package until just prior to use. Use aseptic technique in handling and using this product. Do not use this product after the expiration date indicated on the label. Do not modify this product for any reason. If this product meets resistance or any anomaly during use, do not continue operation. If it is suspected that the product is not normally operating, do not continue to operate the product. While paying much attention to possible complications, carefully withdraw the whole system. Always check the position of the distal end of the microcatheter and guide wire under fluoroscopy. When removing the microcatheter, insert the guide wire in advance. If the tip of the guide wire is prolapsed or bent in small radius, do not leave the tip in such condition. Read the instructions of use of the medical device and the therapeutic agents used with this 3

5 product. This product must be used only by a physician who is trained in peripheral intervention. Do not use this product for the purpose other than the purpose described in these instructions. Refer to Table 2 when using contrast medium or therapeutic agents with this product. Table 2 Injection into the microcatheter Immersion or wipe on the outer surface of the microcatheter Immersion or wipe on the outer surface of the guide wire Ethanol Oil-based contrast medium (Lipiodol) Usable Usable Do not use Do not use Do not use Do not use Do not use Do not use Do not use Other organic solution Excessive repeat of insertion and/or withdrawal of the product may lower the performance of the hydrophilic coating. If a power injector is used to inject a contrast medium or therapeutic agents, the injection pressure must not exceed 6895 kpa (maximum injection pressure). If this product is bent or blocked, do not inject a contrast medium or medication. Do not use any guide wire whose outer diameter exceeds 0.53mm (0.021 inches) for this microcatheter. Do not shape this guide wire. Never use metallic needles or metallic sheaths for insertion and withdrawal of this guide wire. Otherwise, the surface of this guide wire may be damaged significantly. When torquing the guide wire, rotate it clockwise and counterclockwise alternately. Do not exceed two rotations (720 ) in the same direction. When inserting the guide wire while keeping the microcatheter inserted in a blood vessel, take particular care in inserting the guide wire. If the guide wire meets resistance or any irregularity when inserting or withdrawing, stop the manipulation, and withdraw the entire system. If this microcatheter is bent or twisted, do not insert the guide wire and avoid abrupt handling. If this product is inserted into a guiding catheter equipped with a stopcock, do not turn the stopcock to closed position. If using a hemostatic adapter (Y-connector) with the guiding catheter, do not excessively tighten the hemostatic valve to this product, or do not manipulate this product while keeping the valve tightened. When injecting a contrast medium, inject by checking the flow of the contrast medium from the distal end of the microcatheter under fluoroscopy. If there is no flow from the distal end of the microcatheter, stop injecting the contrast medium. 4

6 Precautions Prior to use, check the sterile bag is not opened or damaged, the product is not damaged, kinked, bend or crushed. If any damage is suspected with the sterile bag or the microcatheter, or the guide wire, do not use the product. Verify the distal end of the guide wire before insertion, and be sure to insert the flexible distal end. Do not tighten the torque device excessively to the guide wire. Loosen the torque device before moving its position over the guide wire. Otherwise the guide wire may be damaged. To secure lubricity of the outer surface and the lumen of this product, moisten the outer surface with a heparinized saline and flush the lumen of the microcatheter with a heparinized saline while using this product. In addition, after withdrawing this microcatheter, immerse it in a heparinized saline to keep it moistened. In particular, after injecting a contrast medium or inserting therapeutic agent, sufficiently flush the lumen of the microcatheter with the heparinized saline. When shaping this microcatheter, use the stylet that is provided as the accessory and apply steam. Do not heat the microcatheter by other means. Do not apply excessive force or make an extremely small radius, or pinch it by forceps or fingers. Otherwise, the shaft may be deformed or crushed, the performance of the hydrophilic coating may be lowered. When removing the stylet, support the distal end of the microcatheter with fingers and pull the stylet out slowly. If using a syringe, carefully handle the syringe since injecting embolic material or therapeutic agent(s) into this product may tend to generate high pressure. If the syringe meets abnormal resistance, stop the injection. Against infection after using this product, take sufficient preventive measures, and discard it by appropriate means. Malfunction and Adverse effects During use of this product, the following malfunction and adverse effects may occur. If the malfunction and/or adverse effects are serious, it may induce death or serious complication(s). Note, however, that malfunction and adverse effects are not limited to these. 5

7 1) Malfunction If an excessive force is applied to this product, the following malfunction may occur. Damage Kink (twist) Bend/crush Separation Damage to the hydrophilic coating Burst Withdrawal difficulty Insertion difficulty Occlusion of catheter lumen 2) Adverse effects Possible complications and adverse effects of using this product include, but are not limited to: Bleeding complications Ischemic complications Angiospasm Bradycardia/palpitation Embolism (air, tissue, thrombotic)/obstruction Damage to vessel including vessel dissection, vessel perforation and vessel rupture. Hematoma formation False aneurysm formation Infection How to Use Preparation 1) Remove this product together with the holder from the sterile bag. 2) Using a syringe, inject a heparinized saline into the holder from the flush port. Check that the heparinized saline has been injected to the extent it spills from the other end of the holder. 3) Fasten the torque device to the guide wire at the position where the proximal end of the guide wire does not protrude from the back end of the torque device. Connect the torque device to the connector of the microcatheter and withdraw the microcatheter from the holder. If any resistance is felt when withdrawing the microcatheter from the holder, inject a heparinized saline into the holder again to provide lubricity to the microcatheter. After withdrawal, check again the surface of the microcatheter for sufficient lubricity. Connect a syringe to the back end of the torque device, flush and fill the lumen of the microcatheter with the heparinized saline. 4) Fasten the torque device to the guide wire and connect it to the connector of the microcatheter. 6

8 Insertion 1) Insert the microcatheter with pre-loaded guide wire from the hemostatic adapter (Y-connector/ stopcock) connected to the guiding catheter, advance them together to the distal end of the guiding catheter under fluoroscopy. 2) After checking the position of the distal end under fluoroscopy, advance the guide wire first, and thereafter advance the microcatheter to the intended position. 3) Withdraw the guide wire and the torque device. Fix the connector of the microcatheter to the extension tube connected in advance to the power injector, and perform the injection. Refer to the flow rate in the Table of Flow Rate. If manually injecting the contrast medium, therapeutic agents or embolic material, connect the syringe to the connector of the microcatheter. 4) To prevent the blood from clotting to the inner surface of the microcatheter during the procedure, connect the syringe to the connector of the microcatheter as appropriate, and inject a heparinized saline. 5) To prevent blood from clotting to the surface of the microcatheter during the procedure, connect the syringe to the hemostatic adapter (Y-connector/ stopcock) connected to the guiding catheter, and flush the lumen of the guiding catheter with a heparinized saline as appropriate. Withdrawal After the procedure is completed promptly withdraw this product, and discard it by appropriate means. How to Store When storing the product, do not bend it or place it under a heavy object. In addition, take care not to expose the product to water, and avoid high temperature, high humidity and direct sunlight. Indicated on the product package label. Expiry date 1 set / box Content 7

9 Liability Disclaimer By no means shall "ASAHI INTECC CO., LTD. and its affiliated companies" (hereinafter referred to as the "Company") be liable for accidents, personal injuries, adverse effects due to any improper use of the product(s) or any other use inconsistent with these instructions. In no event shall the Company be liable for any damages either (i) arising out of storage of the product(s) after the shipment from the Company or (ii) due to selection of patients, surgery techniques, or any other medical activities by the medical institution that uses the product(s). "ASAHI" and "Masters PARKWAY" are trademarks or registered trademarks of ASAHI INTECC CO., LTD. in Japan and other countries. 8

10 Table of Flow Rate Example result on injection test with auto injector 1.Equipment ZMA700modelA(Sugan Co., Ltd.) 2.Conditions Temperature of contrast medium 37 INJECTION PRESSURE MONITOR/LIMIT 4137kPa(600psi), 5532kPa(800psi), 6895kPa(1000psi) FLOW SCALE ml/sec LINEAR RISE SECONDS 0.3sec ASAHI Masters PARKWAY HF KIT Effective length of product (cm) General name of contrast medium Iopamidol Iodine content (mg/ml) Viscosity (cp) Setting Parameter Obtained Flow Rate (ml/sec) Dead Space Volume (ml) FLOW RATE (ml/sec) VOLUME (ml) 4137kPa (600psi) 5532kPa (800psi) 6895kPa (1000psi) The flow rate in actual operation can be lower than this example result because of the variety of the viscosity of the contrast medium and/or other condition

11 ASAHI INTECC CO., LTD Akatsuki-cho, Seto, Aichi JAPAN Made in THAILAND EC REP Emergo Europe Molenstraat 15, 2513 BH, The Hague The Netherlands Tel: (31)(0) Fax: (31)(0) ASAHI INTECC CO., LTD. 16.Jun.2014(1 st edition)