Events

Retiro De Equipo (Recall) de PIPELINE EMBOLIZATION DEVICE (25-35MM)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDTRONIC OF CANADA 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
    41765
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-10-20
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Medtronic has identified the potential for an issue with a specific set of lot numbers where the ptfe (polytetrafluoroethylene) coating could delaminate and separate from the delivery wire. delamination and detachment of the ptfe coating material may lead to ptfe coating in the blood stream. ptfe in the blood stream based on its specific size and quantity may be safe or could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial edema peripheral edema incomplete treatment infection local inflammatory response systemic inflammatory response ischemic stroke lysis/necrosis neurological deficit organ impairment shock space occupying lesion thrombosis and hemorrhage. through september 27 2016 medtronic has received a total of five (5) reports for the products that are potentially affected by this issue. medtronic has received no reports of serious injuries or patient death as a result of this issue.

Device

PIPELINE EMBOLIZATION DEVICE (25-35MM)
  • Modelo / Serial
    Model Catalog: FA-71500-25 (Lot serial: A090167); Model Catalog: FA-71400-25 (Lot serial: A090167); Model Catalog: FA-71450-25 (Lot serial: A090167); Model Catalog: FA-71475-25 (Lot serial: A090167); Model Catalog: FA-71425-25 (Lot serial: A090167); Model Catalog: FA-71375-25 (Lot serial: A090167); Model Catalog: 103-0602-300 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 103-0601-300 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 105-5055 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-40 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-50 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-30 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-88810-20 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: FA-71500-25 (Lot serial: A090209); Model Catalog: FA-71400-25 (Lot serial: A090209); Model Catalog: FA-71450-25 (Lot serial: A090209); Model Catalog: FA-71475-25 (Lot serial: A090209); Model Catalog: FA-71425-25
  • Clasificación del producto
    Neurological Devices
  • Descripción del producto
    PIPELINE EMBOLIZATION DEVICE (25-35MM);X-CELERATOR EXCHANGE HYDROPHILIC GUIDEWIRE - SS;MARATHON FLOW DIRECTED MICRO CATHETER;ALLIGATOR RETRIEVAL DEVICE;ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC