Events

Rappel de PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart)

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-00519-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-09
  • 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-00519-1
  • 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
    Biosense webster, a division of johnson and johnson medical, has identified an issue in the production process of the pentaray nav catheter that can lead to an insufficient bond of the distal tip to the catheter shaft. to date, with regard to the affected products, biosense webster has not received any reports of: (i) a complete tip separation from the shaft; or (ii) patient injuries or adverse events as a result of a partial tip separation from the shaft. there is no concern for patients who have already been successfully mapped with the affected products. the incidence rate of the tip to shaft separation is 0.11 % . partial separation exposes the internal components of the catheter to intracardiac blood and could lead to thrombus formation and could become a potential embolic source.
  • Action
    Customers are advised to immediately check their inventory to quarantine if there are affected products.

Device

PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac struct...
  • Modèle / numéro de série
    PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart)Product codes: D128201, D128202, D128204, & D128205All lot numbersARTG number: 203362
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd