Events

Retiro De Equipo (Recall) de Venture RX, OTW and CS 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 Pyramed 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-00538-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-28
  • 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-00538-1
  • 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 vascular solutions (vsi), through an internal investigation has concluded there is the potential for excess material used to manufacture specific venture catheters to be present within the inner lumen of the distal catheter tip. it is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient. to date, the manufacturer has received no reports of adverse patient events related to this issue.
  • Acción
    Pyramed is advising users to immediately cease use of and quarantine the affected units. Pyramed will arrange for the return of affected devices and credit for unused devices after their return.

Device

Venture RX, OTW and CS Catheters
  • Modelo / Serial
    Venture RX, OTW and CS CathetersVenture RX Model Number: 5820Venture OTW Model Number: 5821Venture CS Model Number: 5882 Multiple Lot NumbersSupplied under Special Access Scheme (SAS)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd