Events

Retiro De Equipo (Recall) de Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia 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-2016-RN-00772-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-06-09
  • 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-2016-RN-00772-1
  • 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
    Stryker neurovascular has become aware that some units of the target nano detachable coils do not have the intended stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.The most likely adverse health consequence from coil stretching is prolongation of the procedure, as the stretched coil needs to be removed from the patient and replaced. there is a potential of thrombus formation when the stretched coil is left exposed in the blood flow. additional intervention may be required to snare the stretched coil or pin it to the vessel wall with a stent if safe removal is not possible. this may result in thrombus or thromboembolism which can lead to stroke. there will be no long term adverse health consequence after a stretched coil is removed from the body.
  • Acción
    Stryker is advising users to inspect stock and quarantine any remaining affected units for return. This action has been closed-out on 03/03/2017.

Device

Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)
  • Modelo / Serial
    Target Nano Detachable Coil (used to obstruct or occlude blood flow in blood vessels)Item Numbers: 542102, 542103, 542152, 542153, 542154, 543101, 543102, 543103, 543151, 543152, 543153, 543154, 544203, 544204, 544254, 544304, 544306, 544356, 545202, 545203, 545204, 545206, 545253, 545254, 545256, 545304, 545306, 545308Multiple lot numbers affectedARTG Number: 170214
  • Clasificación del producto
    Neurological Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA