Events

Alerta De Seguridad para Relay Thoracic Aortic Endoprosthesis with Transport Release System - Model: Relay and Relay NBS - ANVISA Registration No. 80003610282

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bolton Medical Espanha S.L.U.

¿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
    1424
  • Fecha
    2014-09-12
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    1. Upon reaching the intended proximal access zone, visually confirm that the distal marking bands of the stent can be seen approximately 2 cm out of the outer primary sheath. 2. If the distal marking bands of the stent do not appear to have come out of the External Primary Sheath, while in Position 1, grasp the Stationary Gray Stamping Tweezers while pulling back the Black Stationary Tweezer until the marking bands distal from the stent exit of the External Primary Sheath by approximately 2 cm.
  • Causa
    A difficulty was observed in the handling of the prosthesis transport system as set forth below: it was observed that in a small number of cases, the internal secondary sheath may not have completely exited the external primary sheath upon reaching the black line. in this situation, the distal end of the stent will also remain inside the external primary sheath. failure to recognize this condition prior to deployment could lead to deployment difficulties or deployment failures. there is no impact on devices already deployed.
  • Acción
    Updating, correcting or supplementing the instructions for use.

Device

Relay Thoracic Aortic Endoprosthesis with Transport Release System - Model: Relay and Relay NBS -...

Manufacturer

Bolton Medical Espanha S.L.U