Events

Retiro De Equipo (Recall) de Copernic2L and Eclipse2L Occlusion Balloon Catheters

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getz Healthcare 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-01311-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-31
  • 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-01311-1
  • 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
    Getz healthcare is advising that damages on the catheters' tubes have been observed during post-marketing surveillance program. this may lead to unusual balloon behaviour during the contrast liquid injection through the guiding catheter, such as unexpected inflation and/or difficult deflation.The manufacturer, balt extrusion has received 3 reports of cases involving this issue, but there have been no reports of patient injury due to these types of failures on the devices. however, these kinds of incidents may lead to patient injury with vascular trauma if the devices are not used in accordance with the recommendations.
  • Acción
    Getz Healthcare is advising users to not insert the double lumen catheters ECLIPSE2L and COPERNIC2L through the Y­ connector's side-arm; they shall be inserted through the axial-arm to prevent any deterioration of the tube. The Instructions for Use will be updated as a permanent measure.

Device

Copernic2L and Eclipse2L Occlusion Balloon Catheters
  • Modelo / Serial
    Copernic2L and Eclipse2L Occlusion Balloon CathetersAll Lot NumbersARTG Numbers: 263592 (Getz Healthcare Pty Ltd - COPERNIC 2L occlusion balloon catheter - Catheter, intravascular, occluding) and;263593 (Getz Healthcare Pty Ltd - ECLIPSE 2L occlusion balloon catheter - Catheter, intravascular, occluding)
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd