Events

Alerte De Sécurité sur AccuTrak Intravascular Catheter System DCS (CoreValve System accessory). Anvisa Registry n ° 10339190448.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MEDTRONIC COREVALVE LLC; Medtronic Comercial Ltda..

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
    1339
  • Date
    2013-12-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Medtronic has identified that the following situations may lead to conical tip separation: (1) Using CoreValve AccuTrak DCS to recover (remove) a partially implanted valve; (2) Remove the CoreValve AccuTrak DCS from the patient after valve implantation without completely closing the CoreValve AccuTrak DCS capsule; (3) Continue to pull the CoreValve AccuTrak DCS if resistance increase is felt in the vessel introducer, hemostatic valve of the introducer, or other structure during recovery of the CoreValve AccuTrak DCS; (4) To reduce the occurrence of cone-tip separation, the company is modifying the DCS-C4-18Fr and DCS-C4-18Fr-23 instructions for use (IFU) and CoreValve AccuTrak DCS training materials; however, no return of the product is required.
  • Cause
    Safety alert to reduce the possibility of separating the tapered end of the device.
  • Action
    Carefully read the manufacturer's instructions (Medtronic) in the Alert Message and pass the information to users of the surgeon product). Access the Medtronic Alert Message at: http://portal.anvisa.gov.br/wps/wcm/connect/abc4e8004228b5f28a33ab6d490f120b/Aviso+Urgente.pdf?MOD=AJPERES.

Device

AccuTrak Intravascular Catheter System DCS (CoreValve System accessory). Anvisa Registry n ° 1033...

Manufacturer

MEDTRONIC COREVALVE LLC; Medtronic Comercial Ltda.
  • 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
    ANVSANVISA