Events

Safety Alert for nMARQ Circular Irrigated Catheter

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biosense Webster.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-07-03
  • Event Date Posted
    2015-07-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150703.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biosense webster nmarq circular irrigated catheter 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.

Device

nMARQ Circular Irrigated Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosense Webster nMARQ Circular Irrigated Catheter
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster