Events

Alerta De Seguridad para Electrophysiological Mapping, Diagnostic and Ablation Catheters THERMOCOOL SMARTTOUCH SF

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 Biosense Webster, 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
    R1709-433
  • Número del evento
    2010DM-0006099
  • Fecha
    2017-09-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=72
  • 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 manufacturer reports that it has been able to identify an increase in the claim rate due to the appearance of the alert message 402 in the carto 3 navigation system with the referenced devices, this alert associates the message "map: magnetic distortion", which could cause the location if the tip of the catheter in the navigation system is not adequate, the navigator manual indicates the steps to follow to resolve this alert, but for the devices involved, these steps are not effective, leading to possible delays in procedures or adverse events. the patients.

Device

Electrophysiological Mapping, Diagnostic and Ablation Catheters THERMOCOOL SMARTTOUCH SF
  • Modelo / Serial
    D134701, D134702, D134703
  • Descripción del producto
    For cardiac electrophysiological mapping, when used as a radiofrequency generator or for cardiac ablation.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.