Events

Alerte De Sécurité sur BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems

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

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
    2016-03-02
  • Date de publication de l'événement
    2016-03-02
  • 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_20160302a.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: biosensors biomatrix flex and biomatrix neoflex coronary drug eluting stent systems medical device manufacturer, biosensors, has issued a medical device safety alert concerning its biomatrix flex and biomatrix neoflex coronary drug eluting stent systems. the manufacturer is initiating a voluntary recall on certain units of biomatrix flex and biomatrix neoflex coronary drug eluting stent system (des) due to potential balloon burst below the rated burst pressure. the manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, the manufacturer concludes that the compromised balloon performance was caused by certain characteristics in the manufacturing process. according to the manufacturer, the production lots manufactured between october to december 2015 could have been similarly affected. the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient’s state of health during percutaneous coronary intervention. patients who have already been implanted with an affected device are not impacted by this field safety corrective action. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2016.

Device

BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosensors BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems
  • Manufacturer
    Biosensors

Manufacturer

Biosensors