Events

Alerte De Sécurité sur SUPER TORQUE® MB Angiographic Catheter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Cordis.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2011-11-29
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111129a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: cordis super torque® mb angiographic catheter medical device manufacturer, cordis, has issued a field safety notice related to a specific subgroup of cordis angiographic catheters, super torque® mb angiographic catheter. manipulation of the super torque® mb angiographic catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter. stretching or elongation of the super torque® mb angiographic catheter during endovascular procedures could result in the marker bands moving along the catheter. in extreme cases, marker bands may come off the super torque® mb angiographic catheter and dislodge into the vascular system. movement of the marker bands can result in inaccurate reference and device sizing. dislodgement of the marker bands into the vascular system can result in additional intervention, embolism, thrombosis, or other vascular complications. the manufacturer is in the process of updating the product labeling. according to local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

SUPER TORQUE® MB Angiographic Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cordis SUPER TORQUER MB Angiographic Catheter
  • Manufacturer
    Cordis

Manufacturer

Cordis