Events

Retiro De Equipo (Recall) de NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic 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-2013-RN-00973-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-16
  • 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-2013-RN-00973-1
  • 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
    Medtronic has identified a labelling issue for lot number 207002011 of the nc sprinter rx balloon dilatation catheter, model ncsp22512x, in which the compliance chart contained inside the package incorrectly references a 2.5mm balloon diameter instead of the correct 2.25mm diameter. if the affected product was utilised referencing the incorrect compliance chart, the target diameter of the balloon may be less than expected, resulting in suboptimal treatment. the situation would require further inflation at a higher pressure or the use of another balloon catheter to resolve the stenosis, resulting in longer procedural duration.
  • Acción
    Medtronic is requesting users to return affected stock for replacement with unaffected product.

Device

NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)
  • Modelo / Serial
    NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)Model Number: NCSP22512XLot Number: 207002011ARTG 154737
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA