Events

Retiro De Equipo (Recall) de Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Stylet)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien 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-01319-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-10-07
  • 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-01319-1
  • 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 the potential for an issue with a specific set of lot numbers of medtronic neurovascular products where the ptfe (polytetrafluoroethylene) coating could de-laminate and separate from the delivery wire. de-lamination 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 could lead to thromboembolic complications or irreversible injuries including but not limited to: intracranial oedema, peripheral oedema, incomplete treatment, infection, local inflammatory response, systemic inflammatory response, ischemic stroke, lysis/necrosis, neurological deficit, organ impairment, shock, space occupying lesion, thrombosis, and haemorrhage.Through september 27 2016, medtronic has received a total of five (5) reports for the products that are potentially affected by this issue however; no reports of serious injuries or patient death have been reported.
  • Acción
    Customers are advised to quarantine and remove all unused affected products in their inventory. Medtronic will be issuing a credit for the returned, unused and unexpired device(s). If replacement product is needed, Medtronic representative can assist customers with identifying suitable replacement products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with your standard patient management protocol.

Device

Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Sty...
  • Modelo / Serial
    Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Stylet)Multiple Catalogue and Lot numbersManufactured between August 2014 and September 2016ARTG Numbers: 190843, 203671, 274595
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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