Events

Alerte De Sécurité sur Relay Thoracic Aortic Endoprosthesis with Transport Release System - Model: Relay and Relay NBS - ANVISA Registration No. 80003610282

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Bolton Medical Espanha S.L.U.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1424
  • Date
    2014-09-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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