Events

Alerta De Seguridad para electrophysiological mapping catheters for diagnosis

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
    I1705-184
  • Número del evento
    2010DM-0006049
  • Fecha
    2017-05-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=87
  • 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 is clarifying the contraindications in the usage instructions (ifu) and the labeling of the product for this catheter with respect to patients with prosthetic valves, the current text in the ifu reports on a contraindication with the device in patients with prosthetic valves that establishes the following: "the use of this catheter may not be appropriate for use in patients with prosthetic valves" this legend is changed to be more clear in this statement of contraindication of the following pentaray® catheters in patients with the form: "do not use prosthetic valves", this with the in order to avoid possible adverse events on patients.

Device

electrophysiological mapping catheters for diagnosis
  • Modelo / Serial
  • Descripción del producto
    Electrophysiological mapping catheters for diagnosis are indicated for the electrophysiological mapping of cardiac structures, for example stimulation and registration only.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.