Alerta De Seguridad para FlexCath Advance Steerable Sheath

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic flexcath advance steerable sheath medical device manufacturer, medtronic, has issued a medical device safety alert concerning its flexcath advance steerable sheath (model number 4fc12). the manufacturer is informing customers regarding an update to the abovementioned product’s instructions for use (ifu) manual. this ifu revision incorporates current best practices for minimizing the potential for air ingress and the risk of air embolism. this ifu update is not in response to a device design deficiency, device malfunction, or a change in reported field performance data. air embolism is a known risk for patients undergoing percutaneous interventions requiring access to the left atrium, such as ablation procedures. according to the 2017 hrs/ehra/ecas/aphrs/solaece expert consensus statement on catheter and surgical ablation of atrial fibrillation, “the most common cause of air embolism is introduction of air via the transseptal sheath.” the manufacturer has supplemented the flexcath advance steerable sheath ifu to highlight the known risk of air embolism more prominently. these updates do not impact current clinical practice as this information is consistent with current training and education materials, and with recommendations from hrs, jhrs, and ehra. users are advised to review the ifu update summary regarding air ingress and air embolism provided by the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 october 2017.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic FLexCath Advance Steerable Sheath
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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