Events

Retiro De Equipo (Recall) de Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation 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-2015-RN-01048-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-10-26
  • 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-2015-RN-01048-1
  • 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
    The potential for a sterile breach in the pouch material was discovered during standard internal packaging tests. the pouch seal breach could potentially result in compromised sterility of the product. following the instructions for use (ifu) would reduce the risk of potential patient harm if issue was easily detectable but in most cases it is not. there have been no reports of adverse patient events related to this issue.
  • Acción
    Customers are advised to remove and quarantine and return all units of the Amphirion Deep Balloon Catheter that remain in their inventory. Patients who have received treatment with an Amphirion Deep PTA Balloon Dilation Catheter affected by this recall should continue to be monitored in accordance with the standard practice. This action has been closed-out on 22/08/2016.

Device

Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Modelo / Serial
    Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation CatheterModel Numbers: AMD253210002, AMD025150152, AMD030120152 Lot Numbers: 209425769, 209436620, 209470464, 209470474, 209507756, 209553426, 209664051, 209722663, 209760068 ARTG Number: 154327
  • 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