Events

Retiro De Equipo (Recall) de ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-2016-RN-00204-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-02-24
  • 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-00204-1
  • 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
    The arrow intra-aortic balloon catheter and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the manufacturer has advised there is the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. in addition, delay of treatment, interruption of treatment, or loss of iab therapy can occur.
  • Acción
    The sponsor is advising customers to immediately quarantine all affected kits. The sponsor will deliver replacement kits to the affected customers before the recovery of the affected kit. In the case of an emergency situation before the replacement kit can be delivered, the sponsor is advising that the Arrow IntraAortic Balloon Catheter can be inserted through the following alternative 8 Fr. sheaths: -St Jude Medical Diag Maximum -Terumo Pinnacle -Cordis Avanti . This action has been closed-out on 23/05/2017.

Device

ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits
  • Modelo / Serial
    ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion KitsProduct Codes : IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-06830-U, IAB-06840-U and IAK-06845Multiple Batch Numbers affectedARTG Numbers: 101617, 106866 and 107249
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd