Events

Rappel de ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular leads in the coronary vasculature)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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-2013-RN-01086-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-22
  • 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-2013-RN-01086-1
  • 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
    Medtronic has identified the potential for an issue with a specific subset of batch numbers of the guide wires where the ptfe (polytetrafluoroethylene) coating could delaminate and detach from the guide wire. this issue affects a subset of a range of guide wires manufactured from mid-april 2013. delamination and detachment of the ptfe coating may lead to embolic occlusion and thrombosis in coronary, cerebral, peripheral or pulmonary vasculature. vascular thrombosis and/or occlusion have the potential to result in irreversible damage or injury to vital organs including myocardial infarction or stroke.
  • Action
    Customers are asked to quarantine all unused product for return to Medtronic. For affected products that have been used, Medtronic is advising that patients should continue to be managed in accordance with hospitals standard patient management protocol.

Device

ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular le...
  • Modèle / numéro de série
    ATTAIN HYBRID Guide Wires (used to aid the placement of Medtronic transvenous left ventricular leads in the coronary vasculature)Model GWR419688Batch Numbers: 0006840866, 0006840879, 0006873688ARTG Number: 153354
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA