Events

Retiro De Equipo (Recall) de Inspira Air Balloon Dilation System (Bronchial balloon catheter)

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-2013-RN-00907-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-02
  • 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-00907-1
  • 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
    There is potential for the balloon to not deflate or deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. reports of difficulty deflating the balloon during a procedure have been received. in each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. the force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. the potential for this issue to occur exists in all lots and all sizes of the inspira air balloon dilation system.
  • Acción
    Johnson & Johnson Medical is updating the information in the instructions for use (IFU) to include the following warnings: - Should the balloon move distally or proximally in the patient while inflated, it is not be held or pulled against. - The Inspira Air Balloon Catheter should only be placed in anatomical locations where a portion of the balloon can be continually visualised to ensure access in the unlikely event of deflation difficulty.

Device

Inspira Air Balloon Dilation System (Bronchial balloon catheter)

Manufacturer

Johnson & Johnson Medical Pty Ltd