Events

Retiro De Equipo (Recall) de Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences 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-2015-RN-00294-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-31
  • 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-2015-RN-00294-1
  • 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
    Through post market surveillance, edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula, sizes 8, 10, and 12 french only. edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use. in a worst-case scenario, if the physician attempted to insert the device, the exposed wire could damage the femoral artery, causing a vascular injury that could require surgical or interventional repair.While there have been no reports of injury associated with this issue, edwards is taking this action to eliminate the chance of tissue damage caused by a protruding wire.
  • Acción
    All affected product is being Recalled from the Market. This action has been closed-out on 17/08/2016.

Device

Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French
  • Modelo / Serial
    Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 FrenchProduct Codes: FEMII008A, FEMII008AT, FEMII010A, FEMII010AT, FEMII012A & FEMII012ATARTG Number: 177959Product Codes: FEMII008V, FEMII010V & FEMII012VARTG Number: 142782Multiple lot numbers affectedARTG number: 142782
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd