Medical device manufacturer, Biosense Webster, has issued a medical device safety communication to reinforce the importance of verifying all device settings prior to ablation with an irrigated catheter.
Through post-market surveillance, the manufacturer has become aware of instances in which irrigated catheters have been used for ablation without proper settings for irrigation. Without proper irrigation, there may be excessive temperature rise at the site of ablation, which, in rare cases, could lead to cerebrovascular event or other serious adverse events.
The manufacturer advised affected users to verify all devices used are set up properly at the beginning of the procedure. Moreover, confirm all settings are correct and devices are functioning as intended during the ablation procedure. Affected users are also advised to review Instructions for Use and User Manual for relevant details.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 4 March 2021