Events

Rappel de Venture RX, OTW and CS 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 Pyramed 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-00538-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-28
  • 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-00538-1
  • 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
    The manufacturer vascular solutions (vsi), through an internal investigation has concluded there is the potential for excess material used to manufacture specific venture catheters to be present within the inner lumen of the distal catheter tip. it is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient. to date, the manufacturer has received no reports of adverse patient events related to this issue.
  • Action
    Pyramed is advising users to immediately cease use of and quarantine the affected units. Pyramed will arrange for the return of affected devices and credit for unused devices after their return.

Device

Venture RX, OTW and CS Catheters
  • Modèle / numéro de série
    Venture RX, OTW and CS CathetersVenture RX Model Number: 5820Venture OTW Model Number: 5821Venture CS Model Number: 5882 Multiple Lot NumbersSupplied under Special Access Scheme (SAS)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd