The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom posted a field safety notice concerning the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F), manufactured by IDEV Technologies.
According to the manufacturer, there were reports of a rare event in which the catheter tip was pulled off during use. The manufacturer has determined that the failure to adhere to the Instructions for Use appeared to be the root cause of these events.
Specifically, if the thumb slide on the catheter handle is not retracted and locked prior to catheter withdrawal, per the Instructions for Use, the catheter tip may catch on the introducer sheath and may be pulled off the catheter body. Removal of the detached tip may be necessary, as determined by the physician. To date, the manufacturer is not aware of these incidents occurring when the Instructions for Use are followed and, no injuries have been reported.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the product, please contact your supplier for necessary actions.