Biosense Webster—nMARQ Circular Irrigated Catheters: Electrodes May Exhibit Low Temperature Measurement Anomaly Because of Thermocouple Malfunction

July 8, 2015 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a June 24, 2015, Urgent Medical Device Recall letter submitted by ECRI Institute member hospitals, Biosense Webster states that the ablation cathters below may exhibit thermocouple malfunction, causing a low temperature anomaly at electrodes of the catheters. Biosense Webster has received reports of 3 deaths of patients treated with the catheters below at the same time of the low temperature reports; 2 reports of which were confirmed to have been caused by atrioesophagheal fistula (AEF). Biosense Webster also states that extensive ablation on the left atrial posterior wall may have been the main contributing factor to the AEFs in the 2 cases of persistent atrial fibrillation that were treated by pulmonary vein isolation and left atrial posterior wall ablation; however, no direct link between the low temperature anomaly and the AEF cases could be confirmed. Biosense Webster further states that the low temperature anomaly may be a secondary risk factor because it may affect power titration and delivery during radio frequency (RF) ablation. The manufacturer has not confirmed the...

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