Medical device manufacturer, Boston Scientific Corporation, has issued a medical device safety alert concerning its Hurricane RX Biliary Balloon Dilatation Catheter. [Affected product distributed in Hong Kong: HURRICANE Rx DILATION BALLOON 4MM 2CM (Universal Product Number (UPN): M00545890; Lot/Batch Number: 25704208)].
The manufacturer is initiating a removal of specific lots/batches of the affected product in response to an increase in complaints of the RX tunnel component (black sheath) detaching from the catheter shaft.
According to the manufacturer, investigation has shown this issue is due to a lower bond strength of the tunnel component, which may lead to detachment.
The most common potential consequences related to a detached RX tunnel component would be a prolonged procedure duration while the device is exchanged. The most severe potential injury would include hemorrhage and/or tissue damage/perforation to the common bile duct during the retrieval of a detached RX tunnel component.
There have been no patient harms reported to date related to the issue.
The removal affects only specific UPNs and lots/batches. Affected users are advised to cease further use of any remaining affected product immediately. Product removal is on-going.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 September 2020