Events

Safety Alert for CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical Navigation System. Registration nº 80145901453. SERIAL NUMBER: NAVIGATION SYSTEM EP - CARTO 3 System: SNs: 50573; 51027; 51021; 50572; 11879; 51022; 50203; 51018; 51020; 50128; 11179; 50530; 50532; 5977

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; 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
    1725
  • Date
    2015-11-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    The company informs that there will be risk if the ultrasound image is being used to monitor the patient during the electrophysiology procedure. If there is a power outage during the ride, the ultrasound image will not reappear until the CARTO® 3 System is restored.
  • Reason
    The company holding the registry informs that the intracardiac ultrasound image will disappear if the power of the carto® 3 navigation system is interrupted and this may present a safety problem if the electrophysiologist is using ultrasound imaging to monitor the patient during the electrophysiology. the ultrasound image will not reappear until the carto® 3 system is restored.
  • Action
    • Read this Field Safety Notice carefully (Appendix). • Give this notice to the people at your facility who need to be informed about the problem, including relevant clinical professionals who are involved in the use of SOUNDSTAR® eco Catheters. • Keep a copy of this letter with the product. • Be aware of this Field Safety Notification

Device

CATHETER SOUNDSTAR ECO and NAVIGATION SYSTEM EP - CARTO 3 System, Model - Catheters and Surgical ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; BIOSENSE WEBSTER INC