Events

Safety Alert for cryocam system

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

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 Number
    2013EBC-0009606
  • Date
    2017-10-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=68
  • 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

Device

cryocam system
  • Model / Serial
    Deflectable Introducer Flexcath Advance
  • Product Description
    Description of the system CRYOCATH's CRYOCATH technology from MEDTRONIC combines the advantages of cardiac catheter ablation and cardiac ablation CRYOCATH from MEDTRONIC produces cryogenic (extremely cold) controlled conditions in the cooling segment of a long, flexible and bi-directional catheter. The system delivers cryogenic temperatures to the internal walls of a latent heart approaching the heart through the body vasculature from a puncture in the skin. The procedure is done to correct electrophysiological abnormalities that lead to irregular or erratic heartbeats. This selectively destroys (performs ablation) groups of cardiac cells (sites generating the arrhythmia), which causes or propagates the abnormality. System is composed of the console, catheters, electrical and gas connectors (called as umbilicals) and other accessories. The figure below shows the components connected to form the system. Crio universal console: the console houses the electronic components and the software to control and record the procedure, stores and controls the delivery of liquid refrigerant under high pressure through the umbilical cable coaxial to the catheter, recovers the expanded vapor from the catheter refrigerant under vacuum, and Disposes the refrigerant through the hospital waste management system. The hardware controls the safety monitoring system while the software supplies the patient information, user interface, procedure temperature, temperature / time set point in automatic mode and information from Procedure data. Electric umbilical cable: the sterile electric umbilical cable is a cable
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA