Events

Retiro De Equipo (Recall) de StarClose SE Vascular Closure System (VCS), International Green Sheath

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abbott Vascular Division of Abbott Australasia 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-00211-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-08
  • 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-00211-1
  • 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
    Product from the affected lots may exhibit difficulty or failure to deploy the starclose se clip. exchange sheath material variation with a higher sheath split force may result in difficulty or failure to deploy the device. potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve haemostasis. to date, there have been no long term or irreversible patient effects reported.
  • Acción
    Customers are advised to cease use of devices from the affected lots immediately and return all unused stock to Abbott Vascular. Abbott Vascular has implemented corrective actions to ensure ongoing product performance and has ceased distributing any product built before the corrective actions. Abbott Vascular will work with customers to replace returned units with similar product, pending availability.

Device

StarClose SE Vascular Closure System (VCS), International Green Sheath

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA