Events

Notificaciones De Seguridad De Campo acerca de Edwards Commander

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Edwards Lifesciences LLC.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-05-20
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Edwards received reports of a leak at the y connector of the balloon filler tube in the commander insertion system. in investigating the reports, we found the following: 1) leakage occurs due to a crack in the tube in addition to the y connector under the relief pipe clamp at the backflow joint in the tube and may affect the ability to fully fill the balloon and fully extend the flap; and 2) in rare cases, failure to fully open the flap at the required location may necessitate postdylation of the flap, placement of the flap in a non-target location, embolization of the flap, or complications associated with the need to surgically remove the flap that is not too open, 3) malfunction may occur due to the handling of the device after manufacture, so our 100% production leak test does not detect it.

Device

Edwards Commander

Manufacturer

Edwards Lifesciences LLC