Instructions for Use - HI-TORQUE ADVANCE Guide Wires

Indications, Contraindications, Warnings, Precautions, Adverse Events

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.  OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS.  FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.

Indications

The HI-TORQUE ADVANCE Guide Wires are intended to facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

Contraindications

The HI-TORQUE ADVANCE Guide Wires are not intended for use in the cerebral vasculature.

Warnings

• This device is designed and intended for ONE TIME USE ONLY. DO NOT RESTERILIZE AND/OR REUSE.
• Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.

Do Not:

• Push, auger, withdraw or torque a guide wire that meets resistance.
• Torque a guide wire if the tip becomes entrapped within the vasculature.
• Allow the guide wire tip to remain in a prolapsed condition.

Do:

• Advance or withdraw the guide wire slowly.
• Use the radiopaque marker of the interventional device to confirm position.
• Examine the tip movement under fluoroscopy before manipulating, moving or torquing the guide wire.
• Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
• Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system.  Perform 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 that the tip is parallel with the vessel wall.
• Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts into a bifurcated vessel. Use of this technique carries additional patient risks, including the risk that the wire may become caught on the stent strut.
• Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.

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 guide wires. Using a damaged guide 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.
• 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.
• 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.
• Avoid abrasion of the hydrophilic coating.
• Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.

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