Events

Retiro De Equipo (Recall) de Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sorin Group Australia.

¿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-00032-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-20
  • 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-2014-RN-00032-1
  • 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
    For the size and lots identified, the blue marker (placed on the catheter shaft close to the balloon proximal extremity, aiding correct positioning of the balloon with respect to the prosthesis, prior to dilation) may detach and displace during removal of the plastic tube which protects the balloon. removal of the plastic tube protection may displace the blue marker distal to the balloon. if this is not identified, the blue marker might then fall in the operative field, including the possibility to fall in the patient ventricle during the post-dilation procedure, causing serious injury or death if it is not retrieved.
  • Acción
    Sorin is recommending that clinicians follow the indications provided in the customer letter to remove the plastic tube protecting the balloon and to verify that the blue marker is not displaced. In case the verification leads to the conclusion that the marker is displaced, the involved post-dilation catheter must not be used and must be replaced with a new one.

Device

Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve ...
  • Modelo / Serial
    Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation)Item number: ICV1149Lot numbers: 1306130204, 1306170173 1307290152, 1309230205ARTG Number: 204444
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia