ARGON Pointer Nitinol Guidewire Instructions
- May 15, 2024
- ARGON
Table of Contents
ARGON Pointer Nitinol Guidewire
Intended Use/Purpose
Pointer™ Nitinol Guidewires are intended to facilitate the percutaneous placement and guidance of a catheter in the peripheral vasculature.
Device Description
Pointer™ Nitinol Guidewires has excellent visibility through high radiopaque coil tip. The device consists of Hydrophilic coating tip for less traumatic path finding and PTFE coated nitinol shaft for minimal friction during device introduction.
Indication for use
The product is for catheter guiding in peripheral vessels.
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 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.
- Make sure the product is compatible with other equipment.
- Not to be used with Rotarex®
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 the guidewire is undamaged.
- Loosen the straightener together with the guidewire.
- Inject saline with syringe in a vertical position.
- Form the tip by running the coil over the edge of the coloured plastic straightener.
- Activate the coating by saline.
Procedure
- Introduce the guidewire, soft end first, through an appropriate access device.
- 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 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.
CUSTOMER SUPPORT
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
EMERGO EUROPE
Wester voortsedijk 60 6827 AT Arnhem The Netherlands
+31 70 345 8570
Emergo Consulting (UK) Limited
c/o Cr 360 – UL International Compass House, Vision Park Histon Cambridge CB24
9BZ United Kingdom
https://www.argonmedical.com/resources/product-information
The symbols glossary is located electronically at
www.argonmedical.com/symbols
References
- Argon Medical Devices | Interventional Solutions That Make a Difference
- Product Symbols | Medical Devices Symbols | Argon Medical Devices
- Quality and Regulatory | Argon Medical Devices
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>