Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its FlexCath Advance Steerable Sheath (Model Number 4FC12).
The manufacturer is informing customers regarding an update to the abovementioned product's Instructions for Use (IFU) manual. This IFU revision incorporates current best practices for minimizing the potential for air ingress and the risk of air embolism. This IFU update is not in response to a device design deficiency, device malfunction, or a change in reported field performance data.
Air embolism is a known risk for patients undergoing percutaneous interventions requiring access to the left atrium, such as ablation procedures. According to the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation, "the most common cause of air embolism is introduction of air via the transseptal sheath."
The manufacturer has supplemented the FlexCath Advance Steerable Sheath IFU to highlight the known risk of air embolism more prominently. These updates do not impact current clinical practice as this information is consistent with current training and education materials, and with recommendations from HRS, JHRS, and EHRA.
Users are advised to review the IFU Update Summary regarding air ingress and air embolism provided by the manufacturer.
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 12 October 2017