Instructions for Use (Brief Summary) - ASAHI Prowater Flex Coronary Guide Wires

Rx ONLY

Indications for Use

ASAHI PTCA guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA guide wire is not to be used in the cerebral blood vessels.

Warnings

• This guide wire is for single use only. Do not reuse or resterilize. If reused or resterilized, the performance or quality of the guide wire may be compromised and there is a risk of complications, including infection.
• Do not use the guide wire after the expiration date indicated on the label. Discard any guide wire that exceeds the expiration date.
• This guide wire must be used only by a physician who is fully trained in PTCA/PTA treatment.
• The coil section is especially fragile, so do not bend or pull it more than necessary. Otherwise, the guide wire may be damaged.
• Do not use a damaged guide wire. Using a damaged guide wire may result in blood vessel damage and/or inaccurate torque response. Injury to the patient may result.
• Always advance and withdraw the guide wire slowly.
• Observe guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy. Do not move or torque a guide wire without observing corresponding movement of the tip; otherwise, the guide wire may be damaged and/or vessel trauma may occur. In addition, ensure that the distal guide wire tip and its location in the vessel are visible during wire manipulations.
• Never push, auger, withdraw, or torque a guide wire that meets resistance. Torquing or pushing a guide wire against resistance may cause guide wire damage and/or guide wire tip separation or direct damage to a vessel. Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the guide wire tip. If guide wire tip prolapse is observed, do not allow the tip to remain in a prolapsed position; otherwise damage to the guide wire may occur. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.
• If any resistance is felt due to spasm or the guide wire being bent or trapped while operating the guide wire in the blood vessel or removing it, do not move or torque the guide wire. Stop the procedure. Determine the cause of resistance under fluoroscopy and take appropriate remedial action. If the guide wire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel.
• When torquing this guide wire inside the blood vessel, do not torque continuously in the same direction. This may cause the guide wire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel. When torquing the guide wire, rotate it clockwise and counterclockwise alternately. Do not exceed two rotations (7200) in the same direction.
• Do not push the guide wire more than is necessary to advance the tip through the narrowed part of the vessel. (For example, do not push the guide wire when the distal tip of the guide wire is bent by the force of manipulation.) After crossing the targeted area, do not roughly twist, push or pull the guide wire. If the guide wire is moved excessively, it may be damaged or break apart, which may injure the blood vessel or leave fragments inside the vessel.
• Use proper technique to ensure and verify that no air enters the interventional device when pulling the guide wire from the interventional device or re-inserting it. Otherwise air embolism could occur.
• Flush the guide wire with heparinized saline or other suitable solution while removing and reinserting it to prevent air from entering the interventional device. Perform guide wire exchanges carefully to prevent air entry and/or trauma. When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and is not against the vessel wall. Failure to do so may result in vessel trauma when the guide wire is removed. Use the radiopaque marker of the interventional device to confirm position.
• Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.
• Do not use in areas of vessel that are not or cannot be visualized.
• For all Guide Wires:
  Use the most suitable guide wire that will treat the lesion. There are patient risks when using any guide wire including those that may result from damage to, or breakage of, the guide wire. If guide wire damage or breakage occurs, it may cause damage to the vessel and injury to the patient, or death. Accordingly, care should be taken that all persons who operate guide wires are properly trained in their use, that they observe proper technique, and that guide wires are used carefully in accordance with the Instructions for Use. Possible complications and adverse events of guide wire use include, but are not limited to:
  
  Failure to cross a lesion
  Separation or breakage of the guide wire
  Damage to a vessel, including possible vessel perforation
  Coronary artery dissection
  Cardiac tamponade due to coronary artery perforation
  Air embolism
  Infection
  Coronary artery spasm
  Coronary artery thrombus
  Hematoma at puncture site
  Cardiac perforation

Precautions

• If the package is opened or damaged, do not use the product. Do not to open the package until just prior to use. Use aseptic technique in handling and using the guide wire.
• Contraindications, warnings, precautions, and intended uses of interventional devices that are compatible with ASAHI PTCA guide wires are described in the user manuals supplied with the respective interventional devices. Before using an ASAHI PTCA guide wire with other interventional devices, read the user manual of the other devices to ensure the other devices are compatible with ASAHI PTCA guide wire. Ensure you choose the correct ASAHI PTCA guide wire and that its use is consistent with the contraindications, warnings, precautions, and Instructions for Use of both the other devices and ASAHI PTCA guide wire.
• Guide wires are delicate instruments and should be handled carefully. When taking the guide wire out of the holder tube, do not handle the guide wire roughly or pull it out abruptly.
• Inspect the guide wire carefully for bends, kinks, or other damage prior to use and whenever possible during the procedure.
• Take due care when using the guide wire to prevent bending or kinking, and stay within standard practice when using the guide wire.
• When shaping the distal end, use the minimum force needed so that the coil is not damaged. Inspect the coil and guide wire for damage after shaping and before using.
• Verify which is the distal end before insertion and be sure to insert the distal end (coiled end).
• Do not wipe this guide wire using an organic solution such as alcohol.

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