Medical device manufacturer, Biosense Webster, has issued a medical device safety alert concerning nMARQ Circular Irrigated Catheter [Catalogue Number: D132214, Lot Number: All].
The manufacturer has recently received an increased number of complaints related to a low temperature measurement anomaly at electrodes of the nMARQ Circular Irrigated Catheter. During the same time period, they have also received three reports of deaths of patients who were treated with the nMARQ Circular Irrigated Catheter. Two of these cases were confirmed to be caused by Atrio-Esophageal Fistula (AEF). Extensive ablation on the left atrial posterior wall may have been the main contributing factor to the AEFs in these two cases of persistent atrial fibrillation that were treated by pulmonary vein isolation and left atrial posterior wall ablation.
According to the manufacturer, no direct link could be confirmed between the low temperature issue and the AEF as it was detected in only one of the two confirmed AEF cases. Therefore, the low temperature issue may be a secondary risk factor as it may affect power titration and delivery during radio frequency ablation.
The manufacturer decided to conduct a removal for all lots of the nMARQ Circular Irrigated Catheter distributed since 2 February 2015 and conduct a full investigation.
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 3 July 2015