Events

Retiro De Equipo (Recall) de Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mapping of 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-2016-RN-00488-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-20
  • 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-00488-1
  • 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 manufacturer, biosense webster, is clarifying the contraindication language in the instructions for use (ifu) and product labelling for use of this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray catheter in patients with prosthetic valves under the contraindication section stating: “[the] use of this catheter may not be appropriate for use in patients with prosthetic valves.” the update to the ifu is to clarify the contraindication statement to the following: “do not use pentaray catheters in patients with prosthetic valves”.If excessive force is applied on the entangled catheter spine, there is a potential for parts to detach and embolise inside the patient’s body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. the likelihood of these serious complications remains low.
  • Acción
    Johnson and Johnson Medical (JJM) are providing users with an updated IFU to follow to ensure the products are not used in patients with prosthetic valves. This action has been closed-out on 10/05/2017.

Device

Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mappi...
  • Modelo / Serial
    Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mapping of the heart)Catalogue Numbers: D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212All Lot Numbers affectedARTG numbers: 129479, 203362, 231772
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd