Events

Safety Alert for EP-CARTO Navigation System

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 || Biosense Webster, Ltd.

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
    I1702-48
  • Event Number
    2007DM-0000863
  • Date
    2017-02-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=102
  • 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 on the electrical activity of the heart and the location of the catheter during electrophysiology (ep) procedures, despite the very low probability (0.000086%) that a patient may experience a ventricular arrhythmia due to a leakage, so which have decided to reinforce this important information, regarding the factors that can contribute to the leakage of current described in the instructions for use, reducing the possibility of potentially adverse events occurring on patients.

Device

EP-CARTO Navigation System
  • Model / Serial
  • Product Description
    The CARTO-XP system is designed to generate cardiac electrophysiological maps in third dimension through decatéteres and provides substantial information about the electrical activity of the heart.
  • Manufacturer
    Biosense Webster,Inc || Biosense Webster, Ltd

Manufacturer

Biosense Webster,Inc || Biosense Webster, Ltd