Events

Retiro De Equipo (Recall) de Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angioplasty of the femoral, renal and iliac arteries)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2015-RN-00286-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-03-27
  • 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-00286-1
  • 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
    Bard peripheral vascular (bpv) has identified that the product code / lot number combinations affected may be at risk of having deflation related issues.In the event a pta balloon will not deflate, immediate intervention is required in order to deflate the balloon and allow for continued blood flow. in many cases, this can be accomplished percutaneously by inserting a device (i.E., guidewire or sheath) to the pta balloon and puncturing the balloon and/or a sheath, allowing its withdrawal. this can usually be completed through the same vascular access, however, may require additional access. in the event a pta balloon cannot be deflated while in the extremities (i.E., superficial femoral artery or av fistula), it may be possible to insert a sterile needle through the skin and reach the balloon and pierce it in order to deflate it. in the event a percutaneous approach cannot successfully deflate the pta balloon, an open surgical approach will be required.
  • Acción
    Customers are advised to remove any affected product from their shelves and contact Bard Australia Customer Service to arrange for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.

Device

Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angi...
  • Modelo / Serial
    Bard ConQuest PTA Balloon Dilatation Catheter (Intended for use in Percutaneous Transluminal Angioplasty of the femoral, renal and iliac arteries)Product Codes: CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124, CQ75124Lot Numbers:REYA0973, REYA2566, REYC0372, REYC0950, REYC1426, REYC2200, REYC2365, REYC2825, REYC2575ARTG Number: 137802
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd