Events

Retiro De Equipo (Recall) de Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Stryker Neurovascular.

¿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
    19898
  • Fecha de inicio del evento
    2016-03-18
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    It was identified that the neuroform atlas pouch and carton label references the incorrect measurement in millimeters for the minimum catheter diameter. the minimum catheter diameter is correctly listed as 0.0165 inches on both product labels, but incorrectly converted to millimetres as 0.69mm. the correct conversion value is 0.42. the 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. the result to the patient being extended procedure/ additional treatment required and increased time under anaesthesia. no adverse health consequences are anticipated. there is no risk to patients associated with previous use of affected devices.
  • Acción
    Manufacturer to issue advice regarding use

Device

Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

Manufacturer

Stryker Neurovascular
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA