Events

Rappel de ThermoCool SF NAV Catheter Family

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00588-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00588-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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