Events

Retiro De Equipo (Recall) de ThermoCool SF NAV Catheter Family

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00588-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-26
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00588-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Due to a higher frequency of reported adverse events related to cardiac perforations and atrio-esophageal fistula johnson & johnson medical is updating the ifu to include the following information:- verify that the catheter selection knob on the compatible rf generator is on the “tcool sf” or thermocool sf similar option and ensure that the maximum temperature is set at 40°c- do not rely on electrode temperature rise to determine if tissue heating is occurring during rf energy delivery as bench and animal studies showed no significant electrode temperature rise during rf ablation.J & j is also providing information to reinforce procedural steps and precautions set out in the ifu.
  • Acción
    J & J is notifying their customers of additional information included in the IFU: - Verify that the CATHETER SELECTION KNOB on the compatible RF generator is on the “Tcool SF” or Thermocool SF similar option and ensure that the maximum temperature is set at 40°C - Do not rely on electrode temperature rise to determine if tissue heating is occurring during RF energy delivery as bench and animal studies showed no significant electrode temperature rise during RF ablation. J & J is also providing information to reinforce procedural steps and precautions set out in the IFU.

Device

ThermoCool SF NAV Catheter Family
  • Modelo / Serial
    ThermoCool SF NAV Catheter FamilyProduct Codes: BNI35DDCT, BNI35FFCT, BNI35JJCT, BNI35FJCT, BNI35DFCT, BNI35BBCT, BNI35BDCT, BNI35BFCT, BNI35DJCT, BNI35DDH, BNI35FFH, BNI35JJH, BNI35FJH, BNI35DFH, BNI35BBH, BNI35BDH, BNI35BFH, BNI35DJHARTG Number: 178843
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd