Events

Safety Alert for CARTOSOUND Module of the CARTO 3 EP Navigation System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biosense Webster.

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
  • Date
    2015-10-02
  • Event Date Posted
    2015-10-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151002b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biosense webster cartosound module of the carto 3 ep navigation system medical device manufacturer, biosense webster, has issued a medical device safety alert concerning its cartosound module of the carto 3 ep navigation system, [catalogue number: c3sound] when used with the soundstar eco 8f and eco 10f diagnostic ultrasound catheter, [catalogue number: 10439236, 10439072, 10439011 & 10438577]. the manufacturer has received one complaint of image disappearance from the cardiac ultrasound system when the carto 3 ep navigation system needed restarting. this occurred while the patient was experiencing pericardial effusion. based on medical evaluation of the health risk profile, the manufacturer believes that the likelihood of harm to the patient is generally low if the ultrasound imaging is not available. however, if the intra-cardiac ultrasound is used to actively monitor an ongoing effusion, the lack of imaging may present a safety issue due to the delay in procuring the resources/equipment to use another imaging modality. the manufacturer will be updating the product labeling to include and further reinforce the above-mentioned precautionary safety information. according to the local supplier, the affected product [cartosound module for the cartro 3 ep navigation system] is distributed to hospitals in hong kong for demonstration purposes. however, soundstar eco 8f and eco 10f catheter are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2015.

Device

CARTOSOUND Module of the CARTO 3 EP Navigation System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosense Webster CARTOSOUND Module of the CARTO 3 EP Navigation System
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster