Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its SpyScope DS Access and Delivery Catheter [Material Number (UPN): M00546600; Multiple batches; Expiration Date Range: 29 Aug 2019 to 21 Nov 2019].
The manufacturer is initiating a voluntary removal of certain batches of SpyScope DS Catheters. An internal investigation found that the working channel sleeve may not be adequately bonded inside of these devices. This may result in the working channel sleeve protruding from the camera cap located at the distal tip of the catheter.
According to the manufacturer, the most common injury reported has been minor tissue damage caused by the protruding working channel sleeve scraping along the duct walls during the procedure. The most serious injury that has been reported is significant bleeding resulting in medical or surgical intervention, including hospital admission and additional procedures.
Affected users are instructed to remove and segregate the affected products immediately. Product removal is on-going.
According to the local supplier, 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 22 December 2017