Events

Alerte De Sécurité sur CATETER THERMOCOOL SMARTTOUCH, Model - Thermocool Smarttouch Bi-directional and Thermocool Smarttouch Uni-directional, Registration nº 80145901380. Lots: See attachment

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1292
  • Date
    2013-09-04
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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