Events

Alerta De Seguridad para AccuTrak Intravascular Catheter System DCS (CoreValve System accessory). Anvisa Registry n ° 10339190448.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COREVALVE LLC; Medtronic Comercial Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1339
  • Fecha
    2013-12-11
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    Safety alert to reduce the possibility of separating the tapered end of the device.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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