Events

Safety Alert for CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smarttouch Uni-directional, Registration nº 80145901380. Lots: See attachment

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.

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
    1292
  • Date
    2013-09-04
  • 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 reports so far, there have been no reports of injury or adverse events in patients as a result of this defect. However, an interruption in the flow of irrigation fluid has the potential to cause overheating of the ablation tip and formation of a burn or thrombus, which in turn may present a thromboembolic risk to the patient./////24/11 / 2014 - The company announced the closure of this field action. According to the company all the customers were contacted, being collected 145 units of the product.
  • Reason
    The company that owns the record reports that biosense webster, maker of the product, recently noticed an increase in reports of interruption of irrigation flow. an internal investigation has identified a defect in the production process, which may cause occlusion of the irrigation lumen.
  • Action
    The company requests that the "Problem description" section be read carefully in the letter attached to this alert. - Immediately identify and separate all affected products to ensure that the product is not used. Keep a copy of this letter along with the THERMOCOOL SMARTTOUCH® catheter until all units are returned to Biosense Webster. - Sign and return the attached Voluntary Field Withdrawal Form, according to the instructions on the form. - Coordinate the return of all THERMOCOOL SMARTTOUCH® catheter units that may be in your inventory, according to the instructions on the Voluntary Field Withdrawal Certification Form. - Transmit this notification to everyone in your facility who needs to be informed. -Be careful of this notification until all affected products have been returned to Biosense Webster. - If any of the affected THERMOCOOL SMARTTOUCH® catheters have been sent to another facility, contact the facility to arrange for a return.

Device

CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smartt...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda