Events

Rappel de Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Sorin Group Australia.

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-2014-RN-00032-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-01-20
  • 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-2014-RN-00032-1
  • 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
    For the size and lots identified, the blue marker (placed on the catheter shaft close to the balloon proximal extremity, aiding correct positioning of the balloon with respect to the prosthesis, prior to dilation) may detach and displace during removal of the plastic tube which protects the balloon. removal of the plastic tube protection may displace the blue marker distal to the balloon. if this is not identified, the blue marker might then fall in the operative field, including the possibility to fall in the patient ventricle during the post-dilation procedure, causing serious injury or death if it is not retrieved.
  • Action
    Sorin is recommending that clinicians follow the indications provided in the customer letter to remove the plastic tube protecting the balloon and to verify that the blue marker is not displaced. In case the verification leads to the conclusion that the marker is displaced, the involved post-dilation catheter must not be used and must be replaced with a new one.

Device

Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve ...
  • Modèle / numéro de série
    Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation)Item number: ICV1149Lot numbers: 1306130204, 1306170173 1307290152, 1309230205ARTG Number: 204444
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia