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- Coronary Intervention
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- Humanitarian Use Device
HI-TORQUE WIGGLE Guide Wire
Indications & Important Safety Information ›› IFU (Full Version) ››
A speciality wire designed to exert a force in a different plane to allow for successful device delivery in calcium and through a previously deployed stent.
Speciality Wire
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HI-TORQUE WIGGLE Guide Wire Tip load: 0.3g
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Tests performed and data on file at Abbott Vascular
| (all wires ship 5 per box) | Diameter (in) | Length (cm) | Tip Shape | Catalog Number |
|---|---|---|---|---|
| HI-TORQUE WIGGLE (2cm) | 0.014" | 190 | Straight | 22299M-W2 |
| HI-TORQUE WIGGLE (2cm) | 0.014" | 300 | Straight | 22359M-W2 |
AP2932993 Rev. A
Indications and Important Safety Information
HI-TORQUE WIGGLE Guide Wire
CAUTION
This device should be used only by physicians trained in angiography and percutaneous transluminal coronary angioplasty (PTCA) and / or percutaneous transluminal angioplasty (PTA).
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
Refer to the instructions supplied with any interventional devices to be used in conjunction with the HI-TORQUE WIGGLE Guide Wire for their intended uses, contraindications, and potential complications.
INDICATIONS
Refer to the device label for any additional product-specific indications which may apply.
The HI-TORQUE WIGGLE Guide Wire is intended to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.
CONTRAINDICATIONS
The HI-TORQUE WIGGLE Guide Wire is not intended for use in the cerebral vasculature.
Refer to the device label for any additional product-specific contraindications which may apply.
WARNINGS
This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE.
Observe all guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.
Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw or torque a guide wire which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.
If the wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.
Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform all exchanges slowly 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 not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit of the device. Use the radiopaque marker of the interventional device to confirm position.
PRECAUTIONS
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged wires. Using a damaged wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use. Test the system for any resistance prior to use. Mild to moderate resistance may be felt as the HI-TORQUE WIGGLE Guide Wire waves are advanced or retracted through the catheter. If severe resistance is encountered, it may be necessary to change to a catheter having a larger guide wire lumen.
Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC Guide Wire Extension.