Events

Safety Alert for THERMOCOOL SMARTTOUCH Catheter

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
    2014-10-23
  • Event Date Posted
    2014-10-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141023a.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 thermocool smarttouch catheter medical device manufacturer, biosense webster, has issued a medical device safety alert concerning its thermocool smarttouch catheter family [catalogue number: d132701, d132702, d132703, d132704, d132705, d133601, d133602, d133603; lot number: all]. biosense webster, a division of johnson & johnson medical nv/sa has observed 34 complaints with a frequency of 0.03% related to a bend/crack at different locations of the shaft of the thermocoolsmarttouch catheter during the time period of january 2012 to july 2014. none of the reported complaints were associated with any adverse events. through the investigation, manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. the manufacturer would like to reinforce the following statements from the warnings and precautions and directions for use in the instructions for use (ifu) for the thermocool smarttouch catheter family: warnings and precautions: do not use excessive force to advance or withdraw the catheter when resistance is encountered. directions for use: to verify compatibility between the sheath and catheter, advance the catheter through the sheath prior to insertion. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 october 2014.

Device

THERMOCOOL SMARTTOUCH Catheter
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosense Webster THERMOCOOL SMARTTOUCH Catheter
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster