Events

Retiro De Equipo (Recall) de Thermocool Smarttouch SF Bi-Directional Navigation 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-2017-RN-01208-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-18
  • 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-2017-RN-01208-1
  • 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 has recently received an increased number of complaints related to the display of alert 402 on the carto 3 system for two specific lots of thermocool brand catheters. alert 402 implies a ‘map: magnetic distortion’ when connected to carto 3 system. magnetic distortion may result in inaccurate catheter tip location information on the carto 3 system. this issue may subsequently lead the physician to ablate in an unintended area when delivering rf energy. severe complications (e.G. av block, vascular injury, cardiac perforation) are highly unlikely but may occur due to the physician selecting higher than required power settings for a given anatomical area.Whilst there have been no reports of adverse events in australia, one adverse event of pericardial effusion requiring pericardiocentesis with no further patient consequences was reported internationally, and was deemed to be potentially associated with this issue.
  • Acción
    1. Users should immediately inspect the device(s) in possession to determine if they hold affected product, if so quarantine this product prior to returning it to J&J; Medical. 2. Complete and return the supplied acknowledgement form, even if no affected product is present, as directed. 3. Return any affected product within 30 business days, by contacting JJM Customer Service on 1800 252 194. 4. Forward this notice to relevant personnel. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable). 5. Maintain awareness of this notice.

Device

Thermocool Smarttouch SF Bi-Directional Navigation Catheter
  • Modelo / Serial
    Thermocool Smarttouch SF Bi-Directional Navigation CatheterProduct Number: D134805Lot Numbers.: 17682911L and 17685902LARTG Number: 233355
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd