Events

Rappel de AngioJet Ultra 5000A Console - Foot Switch

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific 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-00183-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-08
  • 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-00183-1
  • 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 have been reports regarding the angiojet ultra 5000a console foot switch sticking during use resulting in an undesired continued operation of the device. this situation can occur as a result of the wear and tear of the foot switch, which is normally captured through routine servicing. the most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available. at this stage, there have been no reported patient adverse events as a result of these complaints.
  • Action
    Users are advised that if the situation occurs during use, perform the troubleshooting steps per the operator’s manual. An attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter. Boston Scientific is advising users who have this issue to discontinue use of the AngioJet Ultra 5000A Console foot switch and to contact their local sales representative. No action is required by users whose device is operating correctly.

Device

AngioJet Ultra 5000A Console - Foot Switch
  • Modèle / numéro de série
    AngioJet Ultra 5000A Console - Foot Switch ARTG Number: 261713
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA