Safety Alerts

Medical device manufacturer, Boston Scientific Corporation, has issued a medical device safety alert concerning its POLARx and POLARx FIT Cryoablation Balloon Catheters [Material Number (UPN): M004CRBS2000, M004CRBS2100, M004CRBS2010, M004CRBS2060, M004CRBS2110, M004CRBS2160; GTIN Number: 08714729992561, 08714729992660, 08714729992578, 08714729992622, 00191506016456, 00191506016463] [HKMD No.: 230430].

The manufacturer is providing important information regarding updates to the POLARx and POLARx FIT Cryoablation Catheter Instructions for Use (IFUs) related to the risk of atrio-esophageal (AE) fistula. AE fistula is a known and inherent risk for patients undergoing catheter ablation for atrial fibrillation. Although uncommon, esophageal injury is a potentially life-threatening complication due to proximity of the esophagus to the posterior left atrium. Detailed investigation of the available data associated with these AE fistula events did not identify product performance-related issues with any component of the cryoablation system; however, frequency and intensity of cryoablation applications were observed as possible contributing factors. Therefore, the manufacturer is updating the POLARx and POLARx FIT cryoablation balloon catheter IFUs to emphasize the risk of AE fistula, as well as practices that may reduce this risk. These IFU updates align with the FROzEN AF clinical trial.

The manufacturer is communicating these IFU updates to all global customers and affected worldwide regulatory authorities to minimize the risk of AE fistula associated with use of the POLARx Cryoablation System. Following applicable regulatory approval, updated IFUs will be packaged and shipped with corresponding POLARx Cryoablation System devices.

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

Posted on 10 Oct 2024