Events

Alerte De Sécurité sur Rapid Exchange Dilatation Balloon Catheter

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc.

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
  • ID de l'événement
    R1707-313
  • Numéro de l'événement
    2014DM-0012302
  • Date
    2017-07-31
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=77
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The importer has identified that in the referenced devices it may be difficult to remove the stylet, in such case, there is a possibility that the balloon or the catheter could be damaged due to the application of excessive force, so that it could be difficult to inflate or deflate the balloon, leading to possible adverse events on the patient or delays in the procedures.

Device

Rapid Exchange Dilatation Balloon Catheter
  • Modèle / numéro de série
    Euphora and Solarice, lots 212553130 to 213283557.
  • Description du dispositif
    The dilatation balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in order to improve myocardial perfusion. The dilatation balloon catheter is also indicated for post-deployment expansion of expandable balloon stents.
  • Manufacturer
    Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc

Manufacturer

Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA