ARGON IFU1726 Small Diameter Core Wires User Guide
- June 6, 2024
- ARGON
Table of Contents
Nitinol Access Guidewire
Intended Use/Purpose
Nitinol Access Guidewire is used to facilitate percutaneous vessel access during diagnostic and interventional procedures.
Device Description
Nitinol Access Guidewire features a high torque-control and rigid core to
radiopaque coil tip that provides excellent maneuverability.
Indication for use
The product is for catheter guiding in peripheral vessels. Not for use in
Central Circulatory System.
Duration
Transient, less than 60 minutes.
Warnings
-
This device was designed, tested, and manufactured for single use only. Reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection, or another injury.
Do not reuse, reprocess or re-sterilize this device. -
Inspect the package integrity before use.
-
Do not use if the package appears open or if the expiry date has been exceeded.
-
Do not continue to use if any of the components are damaged prior to and during the procedure.
-
Do not advance the wire against resistance until the cause of the resistance has been determined by fluoroscopy. Excess force against resistance may result in damage to the guidewire, catheter, or vessel perforation.
-
Do not withdraw a kinked guidewire through a needle. Straighten the guidewire before withdrawing through the needle.
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The product must only be used by qualified personnel who are familiar with the technique.
Potential Complications
Potential complications include, but are not limited to the following:
- Perforation of a vessel or arterial wall
- Thrombus formation
- Puncture site hematoma
- Vasospasm
- Infection
- Vessel dissection
Preparation
- Make sure the guidewire is undamaged.
- Inject saline with a syringe in a vertical position.
- Activate the coating by saline.
Directions for Use
- Introduce the guidewire, soft end first, through an appropriate access devise.
- Advance the guidewire using fluoroscopy. Rotating the guidewire makes the advancement easier. Use the torque to lead the tip of the guidewire.
Storage: Store at controlled room temperature.
Disposal: After use, this product may be a potential biohazard. Handle in
a manner, which will prevent accidental puncture. Dispose of in accordance
with applicable laws and regulations.
NOTE: In the event, a serious incident related to this device occurs, the event should be reported to Argon Medical at quality.regulatory@argonmedical.com as well as to the competent health authority where the user/patient resides.
ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 (903) 675 9321
Tel: +1 (800) 927 4669
www.argonmedical.com
2797
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
+31 70 345 8570
Argon Medical Devices UK Ltd
Eastgate Business Centre
Eastern Avenue
Burton-on-Trent
Staffordshire
DE13 0AT
IFU1726/0321A
https://www.argonmedical.com/resources/product- information
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