Events

Retiro De Equipo (Recall) de Sinus-SuperFlex-635 Self-expanding Nitinol Stent System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pyramed 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-2015-RN-00701-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-08-12
  • 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-2015-RN-00701-1
  • 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
    An investigation of field complaints indicates an increased number of deployment issues. non-deployments were reported as well partial deployments of the stent. partially deployed stents may require additional intervention by a doctor due to stent elongation or fracture.This does not affect any patients with an implanted stent of this length since the problem may only occur during the implantation of the stent.
  • Acción
    Customers are advised to remove all affected products from their inventory and quarantine them in a separate area for collection by Pyramed Pty Ltd. This action has been closed-out on 18/02/2016.

Device

Sinus-SuperFlex-635 Self-expanding Nitinol Stent System
  • Modelo / Serial
    Sinus-SuperFlex-635 Self-expanding Nitinol Stent SystemModel numbers: 8606-6200 and 8607-6200Lot Numbers: Q009591, Q009592, Q008259, Q010150 and Q015955ARTG Number: 178915
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd