Events

Alerta De Seguridad para Left Atrial Appendage Closure System

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 Boston Scientific Corporation.

¿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
    R1604-149
  • Número del evento
    2010DM-0007757
  • Fecha
    2016-04-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=147
  • 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 informs that he has received reports of embolization of the implant during the procedure as well as after it, leading to the occurrence of adverse events on the patients.

Device

Left Atrial Appendage Closure System
  • Modelo / Serial
    WATCHMAN FLX / WS5020, WS5024, WS5027, WS5031 and WS5035, specific batches.
  • Descripción del producto
    The closure technology of the left atrial appendage WATCHMAN was designed to avoid embolization of the atrial appendage of the left atrial appendage and reduce the risk of life-threatening hemorrhage in nonvalvular atrial confibrillation patients who are suitable for anticoagulant treatment or who present a contraindication for anticoagulant treatment. of instructions for use: reinforcing the existing instructions for use to offer greater guidance regarding the correct use of the hemostasis valve to avoid coiling and to securely seal the valve. Minimizing the possibility of undesirable blood leakage, which could prevent potentially adverse events from occurring. the patient.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA