Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its POLARSHEATH Steerable Sheath [Material Number: M004CRBS3050, GTIN Number: 08714729992684, Lot/Batch Number: All, Expiration Date: All].

Reports of air embolism during atrial fibrillation ablations from a limited number of facilities have been received with no associated deaths since 2020 as reported by the manufacturer. As part of the investigation, it was identified that training on the reinforcement of the Instruction for Use (IFU) content led to a corresponding reduction in complaints. Therefore, the manufacturer has revised the device IFU to further emphasize best practices during use of this device. The updated IFU will be packaged with the medical device that are shipped after all applicable regulatory approvals are obtained for the IFU updates.

The manufacturer recommends the following to affected users:

• Review content of the IFU update.
• Share this information as appropriate to provide awareness, particularly with clinicians in user's hospital that use the device.
• Continue to report all adverse events or quality concerns experienced with use of the device to the manufacturer.

According to the local supplier, the products are not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary action.

Posted on 15 April 2021