United States
International
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- Coronary Intervention
- Peripheral Intervention
- Vessel Closure
- Carotid Intervention
- Humanitarian Use Device
Hi-Torque Versacore Guide Wire System
Indications & Important Safety Information ›› IFU (Full Version) ››
The Hi-Torque Versacore is a peripheral 0.035 GW designed for routine daignostic and device delivery in interventional procedures*. Versacore features a soft, shapeable tip to provide safe access to peripheral lesions and enhanced visibility under fluoroscopy. Versacore also offers excellent torque responses, enabling the device to move consistently and easily around the bends of a patient's vascular system, even when accessing the hardest-to-reach lesions.
* Not intended for use in the coronary or neurovasculature.
Access:
Torqueable wire for deliveribality through tortuous or challenging lesions.
Safety:
Soft shapeable tip designed to for lesion access.
Versatility:
Designed for routine diagnostic and interventional device delivery in angiographic procedures.*
* Not intended for use in the coronary or neurovasculature. See Indications and Important Safety Information for additional information.
| Stock Number | Wire Length | Tip Type |
|---|---|---|
| 1012068-01 |
145 cm |
Modified J |
| 1012068-03 | 145 cm | Standard |
| 1012068-02 | 145 cm | Floppy |
| 1012068-05 | 175 cm |
Modified J |
| 1012068-04 | 175 cm |
Floppy |
| 1012068-09 | 260 cm |
Modified J |
| 1012068-06 | 260 cm | Floppy |
| 1012068-08 | 300 cm | Standard |
| 1012068-07 | 300 cm | Modified J |
AP2932929 Rev.A
Indications and Important Safety Information
Hi-TORQUE Steerable Guide Wire
INDICATIONS
The Hi-Torque Steerable Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
The Hi-Torque Steerable Guide Wire is not intended for use in the coronary or neurovasculature.
CONTRAINDICATIONS
The Hi-Torque Steerable Guide Wire is not intended for use in the coronary or neurovasculature.
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. Wipe the wire before all exchanges.
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 from 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.
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.