Hi-Torque Steelcore™

INTENDED USE

All Hi-Torque Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
 

CONTRAINDICATIONS
Hi-Torque 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.

Observe 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. In addition, during catheter manipulations, ensure that the distal guide wire tip is visible.

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. If guide wire tip prolapse is observed or used for positioning, do not allow the tip to remain in a prolapsed condition; otherwise, damage to the guide wire may occur. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

If the guide 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 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 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.

Hi-Torque Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire in a metal cannula or sharp-edged object.
 

ADVERSE EVENTS
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.