Events

Rappel de Copernic2L and Eclipse2L Occlusion Balloon Catheters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getz Healthcare 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-2017-RN-01311-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-31
  • 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-2017-RN-01311-1
  • 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
    Getz healthcare is advising that damages on the catheters' tubes have been observed during post-marketing surveillance program. this may lead to unusual balloon behaviour during the contrast liquid injection through the guiding catheter, such as unexpected inflation and/or difficult deflation.The manufacturer, balt extrusion has received 3 reports of cases involving this issue, but there have been no reports of patient injury due to these types of failures on the devices. however, these kinds of incidents may lead to patient injury with vascular trauma if the devices are not used in accordance with the recommendations.
  • Action
    Getz Healthcare is advising users to not insert the double lumen catheters ECLIPSE2L and COPERNIC2L through the Y­ connector's side-arm; they shall be inserted through the axial-arm to prevent any deterioration of the tube. The Instructions for Use will be updated as a permanent measure.

Device

Copernic2L and Eclipse2L Occlusion Balloon Catheters
  • Modèle / numéro de série
    Copernic2L and Eclipse2L Occlusion Balloon CathetersAll Lot NumbersARTG Numbers: 263592 (Getz Healthcare Pty Ltd - COPERNIC 2L occlusion balloon catheter - Catheter, intravascular, occluding) and;263593 (Getz Healthcare Pty Ltd - ECLIPSE 2L occlusion balloon catheter - Catheter, intravascular, occluding)
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd