Events

Rappel de IntraClude Intra-aortic Occlusion Device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Edwards Lifesciences 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-2018-RN-00313-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-04-12
  • 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-2018-RN-00313-1
  • 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
    Edwards lifesciences has identified a potential safety risk, which may occur during the use of the intraclude intra-aortic occlusion device (icf100). edwards lifesciences has received a limited number of reports (11 reports since december 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. when present, this leak can be identified through normal monitoring of balloon pressure.
  • Action
    Edwards Lifesciences is advising users to maintain close vigilance of balloon pressure during a procedure in order to identify when additional volume is needed to maintain adequate occlusion. Consider having backup equipment available, such as aortic cross-clamps or additional IntraClude devices. Product return is not required at this time. Currently, unaffected product is not available.

Device

IntraClude Intra-aortic Occlusion Device

Manufacturer

Edwards Lifesciences Pty Ltd