Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Jagwire Straight and Angle Tip High Performance Guidewire. The affected products are identified as follows:
The manufacturer is implementing a voluntary Medical Device Recall Removal for specific lots of the affected products in China only, because there was an increase in the rate of complaints about tip detachment of the affected products being reported from China between October and November of 2015.
According to the manufacturer, this increase was caused by the implementation of an over-pouching process in China. Investigation revealed that this process increased the rate of tip detachment by trapping moisture present during shipping and storage in high humidity conditions within the pouch. The tip detachment could lead to device fragments left behind inside the biliary system which would pass naturally or potentially perforation due to exposed underlying guidewire. As at 28 December 2015, no serious injuries have been reported.
The manufacturer instructs the affected users to take the following actions:-
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 January 2016