Events

Retiro De Equipo (Recall) de Cordis PRECISE PRO RX Nitinol Stent System (Carotid)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2016-RN-00625-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-11
  • 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-2016-RN-00625-1
  • 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
    Based on complaints and a subsequent investigation, the manufacturer has detected an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member.The reported issues may result in an intra-procedural delay for the patient while a replacement device is prepped. partial stent deployment may result in vessel damage (carotid dissection or perforation, vessel spasm) requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment. in most severe cases, partial stent deployment may potentially result in transient ischaemic attack or stroke.Cordis have isolated the issue to product manufactured between 27 april 2015 and 22 november 2015. product that has been manufactured after 22 november 2015 is not affected.
  • Acción
    Users are asked to immediately identify and quarantine all products listed in the customer letter in a manner that ensures the affected products will not be used and to complete the attached acknowledgement form, follow the instructions given and to forward this notice to anyone in your facility that needs to be informed. This action has been closed-out on 04/05/2017.

Device

Cordis PRECISE PRO RX Nitinol Stent System (Carotid)

Manufacturer

Johnson & Johnson Medical Pty Ltd