Events

Alerte De Sécurité sur Precise Pro RX Nitinol Stent System (Carotid)

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 Corporation.

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
    2016-05-10
  • Date de publication de l'événement
    2016-05-10
  • 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_20160510b.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
    Medical device safety alert: cordis precise pro rx nitinol stent system (carotid) medical device manufacturer, cordis corporation, inc. (cordis) has issued a medical device safety alert concerning its precise pro rx nitinol stent system (carotid) [catalog numbers: pc0640xce, pc0730xce, pc0740xce, pc0840xce, pc0930xce and lot numbers: 17344454, 17337067, 17256212, 17308315, 17381651, 17323769, 17314384]. based on recent complaints and subsequent investigation, the manufacturer has determined that products made between 27 apr 2015 and 22 nov 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. product manufactured after 22 nov 2015, including product currently manufactured and supplied are not affected. there have been no patient injuries reported to the manufacturer related to this issue. according to the manufacturer, the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared; vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment; or in most severe cases, transient ischaemic attack or stroke. the manufacturer is voluntarily recalling the affected lots. according to the local supplier, the affected lots are distributed in hong kong. if you are in possession of the affected lots, please contact your supplier for necessary actions. posted on 10 may 2016.

Device

Precise Pro RX Nitinol Stent System (Carotid)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cordis Precise Pro RX Nitinol Stent System (Carotid)
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation