Events

Alerta De Seguridad para BEGRAFT BENTLEY Coronary Stent 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 Bentley Innomed Gmbh.

¿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
    R1706-247
  • Número del evento
    2014DM-0011011 ; 2014DM-0012309
  • Fecha
    2017-06-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • 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 has identified that the use of the referenced devices has presented problems related to the compatibility of use with the 7 f sheath, since the passage through the sheath can be critical, it could cause prolonged bleeding times or perforations of the vessel, leading to their potential presentation. adverse events on patients.

Device

BEGRAFT BENTLEY Coronary Stent System
  • Modelo / Serial
  • Descripción del producto
    Indicated for transluminal implantation in the coronary arteries or grafts derived from the aorta-coronary for the treatment of: acute perforation or rupture of the coronary arteries, aneurysms of the coronary arteries or vein bypass graft. Patients who are being considered for endoprosthesis implantation must be acceptable candidates for coronary artery bypass graft surgery. Indicated for chronic intraluminal implant in renal oilic arteries for restoration and improvement of distensibility and treatment of aneurysms and perforations, ruptures and fistulas sharp
  • Manufacturer
    Bentley Innomed Gmbh

Manufacturer

Bentley Innomed Gmbh