Events

Rappel de Magellan Robotic System (Catheter controller steering unit )

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtel 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-2015-RN-00341-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-04-16
  • 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-2015-RN-00341-1
  • 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
    Hansen medical has recently become aware of an incident, which occurred during the catheter installation steps for peripheral vascular procedure. a magellan robotic catheter 6fr was manually inserted a short distance into the patient’s femoral artery, as required. however, during the subsequent catheter installation steps, system buttons were simultaneously pressed while removing, then reinstalling the guide wire support, which is a variation from the ifu instructions. during this sequence of steps, the user pressed a button to retract the catheter, installed the guide wire support, then released the button. the catheter did not stop retracting as expected when the button was released. instead, the system fully retracted the catheter, removing the introducer and patient patch along with the catheter, and vascular access was lost. this system behaviour can only occur during the catheter installation workflow and not during navigation or delivery of therapy.
  • Action
    If this situation should occur, Medtel is requesting the users to press the Emergency Stop button as described in the Magellan Robotic System Instructions for Use (IFU). Medtel is also scheduling field safety training and re-training the Magellan physician-operator to the information contained herein.

Device

Magellan Robotic System (Catheter controller steering unit )
  • Modèle / numéro de série
    Magellan Robotic System (Catheter controller steering unit )Catalogue Number: 11139All Serial NumbersARTG Number: 194358
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA