Events

Retiro De Equipo (Recall) de Zilver PTX Drug-Eluting Peripheral Stent

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia 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-2013-RN-00359-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-26
  • 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-2013-RN-00359-1
  • 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
    Cook medical has received a number of complaint reports relating to the delivery system for the zilver ptx drug eluting stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section. this recall follows from a previous recall for product correction rc-2012-rn-01282-1.
  • Acción
    Cook Medical is initiating the recall of Zilver PTX devices since there is a higher than expected potential of inner delivery catheter breakage due to inconsistencies in the catheter manufacturing process. The recall is intended to address the patient risks that may be associated with the potential failure mode.

Device

Zilver PTX Drug-Eluting Peripheral Stent

Manufacturer

William A Cook Australia Pty Ltd