Events

Safety Alert for Electrophysiological Mapping, Diagnostic and Ablation Catheters THERMOCOOL SMARTTOUCH SF

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Biosense Webster, Inc..

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
  • Event ID
    R1709-433
  • Event Number
    2010DM-0006099
  • Date
    2017-09-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=72
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has been able to identify an increase in the claim rate due to the appearance of the alert message 402 in the carto 3 navigation system with the referenced devices, this alert associates the message "map: magnetic distortion", which could cause the location if the tip of the catheter in the navigation system is not adequate, the navigator manual indicates the steps to follow to resolve this alert, but for the devices involved, these steps are not effective, leading to possible delays in procedures or adverse events. the patients.

Device

Electrophysiological Mapping, Diagnostic and Ablation Catheters THERMOCOOL SMARTTOUCH SF
  • Model / Serial
    D134701, D134702, D134703
  • Product Description
    For cardiac electrophysiological mapping, when used as a radiofrequency generator or for cardiac ablation.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.