Events

Rappel de Inspira Air Balloon Dilation System (Bronchial balloon 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-2013-RN-00907-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-09-02
  • 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-00907-1
  • 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
    There is potential for the balloon to not deflate or deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. reports of difficulty deflating the balloon during a procedure have been received. in each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. the potential for this issue to occur exists in all lots and all sizes of the inspira air balloon dilation system.
  • Action
    Johnson & Johnson Medical is updating the information in the instructions for use (IFU) to include the following warnings: - Should the balloon move distally or proximally in the patient while inflated, it is not be held or pulled against. - The Inspira Air Balloon Catheter should only be placed in anatomical locations where a portion of the balloon can be continually visualised to ensure access in the unlikely event of deflation difficulty.

Device

Inspira Air Balloon Dilation System (Bronchial balloon catheter)

Manufacturer

Johnson & Johnson Medical Pty Ltd