Events

Retiro De Equipo (Recall) de Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)

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 South Pacific.

¿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-00298-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-16
  • 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-00298-1
  • 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 the product labels (pouch and carton) for the neuroform atlas stent catheter contains an incorrect conversion from inches to millimetres for the minimum catheter diameter dimension (0.0165in 0.69 mm). the correct dimensions are 0.0165in (0.42mm). this labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. if this happens, additional procedure/treatment would be required and the patient may be exposed to increased time under anaesthesia.
  • Acción
    The sponsor is advising that the affected devices can continue to be used, provided that the correct dimensions listed in the product directions for use (DFU) are followed. This action has been closed-out on 23/01/2017.

Device

Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneury...
  • Modelo / Serial
    Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)Item numbers: EZAS3024, EZAS3015, EZAS4015, EZAS4530, EZAS3021, EZAS4521 and EZAS4024.All lot numbersSupplied under the Special Access Scheme
  • Manufacturer
    Stryker South Pacific

Manufacturer

Stryker South Pacific
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA