Events

Rappel de Thermocool Smarttouch SF Bi-Directional Navigation Catheter

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-2017-RN-01208-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-18
  • 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-2017-RN-01208-1
  • 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
    The manufacturer biosense webster has recently received an increased number of complaints related to the display of alert 402 on the carto 3 system for two specific lots of thermocool brand catheters. alert 402 implies a ‘map: magnetic distortion’ when connected to carto 3 system. magnetic distortion may result in inaccurate catheter tip location information on the carto 3 system. this issue may subsequently lead the physician to ablate in an unintended area when delivering rf energy. severe complications (e.G. av block, vascular injury, cardiac perforation) are highly unlikely but may occur due to the physician selecting higher than required power settings for a given anatomical area.Whilst there have been no reports of adverse events in australia, one adverse event of pericardial effusion requiring pericardiocentesis with no further patient consequences was reported internationally, and was deemed to be potentially associated with this issue.
  • Action
    1. Users should immediately inspect the device(s) in possession to determine if they hold affected product, if so quarantine this product prior to returning it to J&J; Medical. 2. Complete and return the supplied acknowledgement form, even if no affected product is present, as directed. 3. Return any affected product within 30 business days, by contacting JJM Customer Service on 1800 252 194. 4. Forward this notice to relevant personnel. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable). 5. Maintain awareness of this notice.

Device

Thermocool Smarttouch SF Bi-Directional Navigation Catheter
  • Modèle / numéro de série
    Thermocool Smarttouch SF Bi-Directional Navigation CatheterProduct Number: D134805Lot Numbers.: 17682911L and 17685902LARTG Number: 233355
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd