Events

Alerte De Sécurité sur Hydrofinity Hydrophilic Guidewire

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

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
    2014-06-19
  • Date de publication de l'événement
    2014-06-19
  • 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_20140619a.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: nitinol devices & components hydrofinity hydrophilic guidewire the united states food and drug administration (fda) has issued a medical device safety alert concerning hydrofinity hydrophilic guidewires, manufactured by nitinol devices & components, inc. the manufacturer announced a voluntary recall of the hydrofinity hydrophilic guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. vessel occlusion may necessitate surgical intervention to resolve. two cases were reported where the polymer jacket separated from the device and embolized. one case required surgical intervention. for details, please refer to the fda websites:http://www.Fda.Gov/safety/recalls/ucm401753.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2014.

Device

Hydrofinity Hydrophilic Guidewire

Manufacturer

Nitinol Devices & Components