Events

Safety Alert for electrophysiological mapping catheters for diagnosis

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
    I1705-184
  • Event Number
    2010DM-0006049
  • Date
    2017-05-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=87
  • 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 is clarifying the contraindications in the usage instructions (ifu) and the labeling of the product for this catheter with respect to patients with prosthetic valves, the current text in the ifu reports on a contraindication with the device in patients with prosthetic valves that establishes the following: "the use of this catheter may not be appropriate for use in patients with prosthetic valves" this legend is changed to be more clear in this statement of contraindication of the following pentaray® catheters in patients with the form: "do not use prosthetic valves", this with the in order to avoid possible adverse events on patients.

Device

electrophysiological mapping catheters for diagnosis
  • Model / Serial
  • Product Description
    Electrophysiological mapping catheters for diagnosis are indicated for the electrophysiological mapping of cardiac structures, for example stimulation and registration only.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.