Events

Retiro De Equipo (Recall) de Euphora Semi-Compliant Rapid Exchange 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-2017-RN-00862-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-14
  • 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-2017-RN-00862-1
  • 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 received reports of difficulties in removing the stylette of the euphora semi-compliant rapid exchange (rx) balloon dilatation catheter. in the event that stylette removal difficulties are encountered, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges. potential risks associated with balloon inflation and deflation difficulties include prolonged procedure time and the need for additional intervention. in addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury. medtronic has received one report of patient injury related to this matter.
  • Acción
    Medtronic is requesting customers: 1. Identify and quarantine all unused affected product as listed in your inventory; 2. Return all unused, affected product listed in your inventory to Medtronic. Contact Customer Service on 1800 668 670 to initiate a product return and credit. Your Medtronic Representative can assist you in the return of affected product as necessary; and 3. Complete the supplied Customer Acknowledgement Form and fax it to Medtronic on 1800 929 645 to the attention of ANZ Regulatory Affairs or scan and email to rs.anzregaffairs@medtronic.com with TGA Ref # “RC-2017-RN-XXXXX-X” in the subject line.

Device

Euphora Semi-Compliant Rapid Exchange Balloon Dilatation Catheter
  • Modelo / Serial
    Euphora Semi-Compliant Rapid Exchange Balloon Dilatation CatheterLot Number range: 212553130 to 213283557Expiration Date range: 4 Jan 2019 to 9 May 2019Multiple Model NumbersARTG Number: 238388
  • Clasificación del producto
    Cardiovascular Devices
  • 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