Events

Safety Alert for THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip 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
    2014-04-15
  • Event Date Posted
    2014-04-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140415a.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 webstar thermocool sf nav diagnostic/ablation deflectable tip catheter the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning thermocool sf nav diagnostic/ablation deflectable tip catheter, manufactured by biosense webster. the manufacturer has identified a higher frequency of spontaneously reported adverse events related to cardiac perforations and atrio-esophageal fistula (aef) with the uni-directional and bi-directional thermocool sf nav catheter family during the time period of january 2010 to december 2013 as compared to other navigational thermocool ablation catheters. the manufacturer has not yet identified a definitive cause for this observed difference in frequency of adverse events for the uni-directional and bi-directional thermocool sf nav catheter family. meanwhile, the manufacturer advises that two factors should be considered in relation to these reported adverse events: the increased stiffness and the related handling properties of the thermocool sf nav catheter family may contribute to the risk for perforation. due to the enhanced cooling feature of the thermocool sf nav catheter, application of the same power settings, guided by temperature feedback, as previously used with other navigational thermocool catheters may result in relatively deeper lesions and potentially contributes to higher rate of aef and cardiac perforations. the manufacturer also reminds users to pay special attention on relevant warnings and precautions in the instructions for use (ifu) for the thermocoolsf nav catheter family models. according to the local supplier, johnson & johnson (hong kong) ltd, the affected products were distributed in hong kong. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con402544 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 15 april 2014.

Device

THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosense Webstar THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster