Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its MAMBA 135 and MAMBA Flex 135 Microcatheters. The affected devices are identified as the following: -
The manufacturer is initiating a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. The manufacturer has received complaints that the MAMBA 135 Microcatheter (red strain relief) was found to have the label and packaging of the MAMBA Flex 135 Microcatheter (green strain relief) and vice versa. The manufacturer has not received any reports of patient injury associated with this incorrect labeling and packaging issue. This labeling and packaging issue is readily identifiable as the color coding on the box and on the catheter strain relief will not match.
According to the manufacturer, while not expected to occur, the most serious adverse health consequence would be procedure prolongation due to the difficulty to maneuver the microcatheter or inability to reach the desired/targeted anatomic locations. This could result in a necessity for a microcatheter exchange during the catheter preparation and/or during the procedure.
The manufacturer is instructing affected users to segregate the product immediately and return it to the manufacturer.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 10 March 2021