Events

Retiro De Equipo (Recall) de IntraClude Intra-aortic Occlusion Device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00313-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-04-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00313-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Edwards lifesciences has identified a potential safety risk, which may occur during the use of the intraclude intra-aortic occlusion device (icf100). edwards lifesciences has received a limited number of reports (11 reports since december 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. when present, this leak can be identified through normal monitoring of balloon pressure.
  • Acción
    Edwards Lifesciences is advising users to maintain close vigilance of balloon pressure during a procedure in order to identify when additional volume is needed to maintain adequate occlusion. Consider having backup equipment available, such as aortic cross-clamps or additional IntraClude devices. Product return is not required at this time. Currently, unaffected product is not available.

Device

IntraClude Intra-aortic Occlusion Device

Manufacturer

Edwards Lifesciences Pty Ltd