Events

Retiro De Equipo (Recall) de Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion)

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-2014-RN-00715-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-04
  • 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-2014-RN-00715-1
  • 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
    Through the investigation of the complaints, cordis and creganna-tactx have observed that the balloon of the affected product, which is covered with a hydrophilic coating, may exhibit resistance to the removal of the balloon cover. weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. use of a weakened catheter may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. there is no concern for patients who have already been treated successfully with the affected product.
  • Acción
    Johnson & Johnson Medical is advising end users that if unusual force is required during the removal of the shipping stylet and/or balloon cover, the unit is not be used. This warning is also being added to the product labelling.

Device

Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation C...
  • Modelo / Serial
    Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion)All Catalog Numbers and all unexpired Lots
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd