ARGON Worker Guidwire Standard Instructions
- June 6, 2024
- ARGON
Table of Contents
ARGON Worker Guidwire Standard
Intended Use/Purpose
The device is used to facilitate the placement of catheters.
Device Description
WORKER™ Standard Guidewires have a fixed stainless-steel core with a polytetrafluoroethylene (PTFE) coating used to reduce friction. It offers a colour-coded straightener that holds the wire in the dispenser and provides easy introduction in the puncture needle or catheter.
Indication for use
The product is for vascular and non-vascular procedures. 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 other injury. Do not reuse, reprocess or re-sterilize this device.
- Inspect the package integrity before use.
- Do not use if package appear open or if the expiry date has been exceeded.
- Do not continue to use if any of the component are damaged prior 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 guidewire, or catheter, or vessel perforation.
- Do not withdraw a guidewire through a needle. Straighten the guidewire in order to withdraw the needle.
- 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 vessel or arterial wall
- Thrombus formation
- Puncture site hematoma
- Vasospasm
- Infection
- Vessel dissection
Preparation
- Make sure that the guidewire is undamaged.
- Loosen the straightener together with the guidewire.
- Inject saline with syringe in a vertical position.
- Make sure the product is compatible with other equipment.
Directions for Use
- Insert the flexible end of the guidewire into the device. Avoid overly vigorous manipulation of the guidewire to prevent damage of vessel or device.
- Advance the guidewire through the device.
- Position the guidewire.
- Hold the guidewire in place and withdraw the device.
- Advance the catheter over 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 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.