Medical device manufacturer, Argon Medical Devices, has issued a medical device safety alert concerning its Worker Guidewire Amplatz, Straight [Argon Part Numbers: A) 114135150; B) 114135080; Lot Number: A) 12239540, 11241250; B) 11235895, 11240602].
The manufacturer has received a complaint from an international customer regarding a perceived increase in the stiffness of the soft/floppy end of the Worker Guidewires and reported an issue during a procedure where the guidewire easily perforated tissue during a procedure.
The manufacturing process for the guidewire includes trimming of the flexible tip to the specified 3.5 cm length. The affected product was found to have a 1.0 cm tip. The manufacturer has examined all in-house inventories, and the issue is limited only to the two-catalog numbers.
As a precautionary measure, the manufacturer is conducting this recall to notify its users of this operator error. Theoretically, there is a risk that if product is used with a wrong length dimension, those units could contribute to heightened risk associated with a puncture to a blood vessel or organ. Before using the product, users should double-check the dimension and tactile differentiability at the end tip of the wire. The affected user should be able to feel the difference in wire stiffness.
According to the manufacturer, it has identified the cause in the manufacturing process, and corrective actions and inspections have been implemented to prevent this from happening again in the future. All affected product should be returned to the manufacturer.
Product replacement is on-going.
According to the manufacturer, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 January 2020