Events

Retiro De Equipo (Recall) de PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart)

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-00519-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-09
  • 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-00519-1
  • 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
    Biosense webster, a division of johnson and johnson medical, has identified an issue in the production process of the pentaray nav catheter that can lead to an insufficient bond of the distal tip to the catheter shaft. to date, with regard to the affected products, biosense webster has not received any reports of: (i) a complete tip separation from the shaft; or (ii) patient injuries or adverse events as a result of a partial tip separation from the shaft. there is no concern for patients who have already been successfully mapped with the affected products. the incidence rate of the tip to shaft separation is 0.11 % . partial separation exposes the internal components of the catheter to intracardiac blood and could lead to thrombus formation and could become a potential embolic source.
  • Acción
    Customers are advised to immediately check their inventory to quarantine if there are affected products.

Device

PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac struct...
  • Modelo / Serial
    PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart)Product codes: D128201, D128202, D128204, & D128205All lot numbersARTG number: 203362
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd