Events

Alerta De Seguridad para Rapid Exchange Dilatation Balloon Catheter

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1707-313
  • Número del evento
    2014DM-0012302
  • Fecha
    2017-07-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=77
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The importer has identified that in the referenced devices it may be difficult to remove the stylet, in such case, there is a possibility that the balloon or the catheter could be damaged due to the application of excessive force, so that it could be difficult to inflate or deflate the balloon, leading to possible adverse events on the patient or delays in the procedures.

Device

Rapid Exchange Dilatation Balloon Catheter
  • Modelo / Serial
    Euphora and Solarice, lots 212553130 to 213283557.
  • Descripción del producto
    The dilatation balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in order to improve myocardial perfusion. The dilatation balloon catheter is also indicated for post-deployment expansion of expandable balloon stents.
  • Manufacturer
    Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc

Manufacturer

Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc
  • 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
    NIDFSINVIMA