Events

Rappel de Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angioplasty of the femoral, renal and iliac arteries)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard Australia 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-2015-RN-00286-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-03-27
  • 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-2015-RN-00286-1
  • 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
    Bard peripheral vascular (bpv) has identified that the product code / lot number combinations affected may be at risk of having deflation related issues.In the event a pta balloon will not deflate, immediate intervention is required in order to deflate the balloon and allow for continued blood flow. in many cases, this can be accomplished percutaneously by inserting a device (i.E., guidewire or sheath) to the pta balloon and puncturing the balloon and/or a sheath, allowing its withdrawal. this can usually be completed through the same vascular access, however, may require additional access. in the event a pta balloon cannot be deflated while in the extremities (i.E., superficial femoral artery or av fistula), it may be possible to insert a sterile needle through the skin and reach the balloon and pierce it in order to deflate it. in the event a percutaneous approach cannot successfully deflate the pta balloon, an open surgical approach will be required.
  • Action
    Customers are advised to remove any affected product from their shelves and contact Bard Australia Customer Service to arrange for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.

Device

Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angi...
  • Modèle / numéro de série
    Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angioplasty of the femoral, renal and iliac arteries)Product Codes: CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124Lot Numbers:REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575ARTG Number: 137802
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd