Events

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

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
    1467
  • Date
    2014-11-24
  • 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
    Based on the research, including the medical evaluation of the health risk profile of the post-marketing reports, Biosense Webster believes that the general risk profile of these catheters is still within acceptable limits when used in the indicated population. To date, no harm or adverse events have been reported in patients as a result of this type of occurrence. The manufacturer would like to stress that there is no flaw or deterioration in the characteristics associated with these products. Therefore, the product may continue to be used.
  • Reason
    The registrant reports that biosense webster, a division of johnson & johnson medical nv / sa, has observed 34 complaints with a frequency of 0.03% related to bending / breaking in different locations on the stem (body) of the thermocool smarttouch catheter, during the period from january 2012 to july 2014. none of these reported claims were associated with adverse events. through the investigation, manual pre-casting of the distal catheter shaft and the use of 8 fr sheaths have been identified as the two primary causes for these events, and may be related to the process of using the products. additional note: this is a voluntary communication from the manufacturer to the customers regarding the event reported through customer complaints. the information contained in this field safety notification is not related to defect or any other defect of the products mentioned.
  • Action
    The company requests that the information contained in the Customer Letter (Security Notification) be carefully read; • Pass this notice to anyone involved in your organization who needs to be informed, including the clinical staff who use the THERMOCOOL SMARTTOUCH catheters and who sign the receipt form; • Review, complete, sign and return the receipt form according to the instructions listed on the form; • Keep a copy of this letter with the product. For more information, please check the Customer Letter - Annex I

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; BIOSENSE WEBSTER INC.