Events

Retiro De Equipo (Recall) de Wingman35 Crossing 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 Diverse Devices 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-00578-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-09
  • 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-00578-1
  • 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 reflow medical, has identified specific lots of wingman35 crossing catheters may be prone to tip detachment. if a catheter tip detaches from the wingman 35 crossing catheter within the vasculature, it could cause injuries to blood vessel walls, thrombotic events, foreign body embolisation, heart attacks and death. the manufacturer has received no reports of injury or death associated with the tip failures.
  • Acción
    Diverse Devices is advising users to stop using and quarantine all affected products. Affected products are to be returned to Diverse Devices for replacement.

Device

Wingman35 Crossing Catheters
  • Modelo / Serial
    Wingman35 Crossing CathetersWingman 35 Crossing Catheter, 65cmReference: WGM35065CELot Numbers: 15087074R1Wingman 35 Crossing Catheter, 90cmReference: WGM35090CELot Numbers:1505144R, 1508264, 1603214R2, 1605194RWingman 35 Crossing Catheter, 135cmReference: WGM35135CELot Numbers: 1505264, 1508204, 1604213R, 160620RARTG Number: 246377
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Diverse Devices Pty Ltd

Manufacturer

Diverse Devices Pty Ltd