Events

Alerte De Sécurité sur Ventricular Catheter (AESCULAP ​​HYDROCEPHAL SYSTEM, Registration no. 80136990434 - lot: 4505252662 and PROGAV - GRAVITACIONAL VALVE FOR AESCULAP ​​HYDROCEPHAL, Registration 80136990624 - Serial numbers / codes Annex)

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 Laboratórios B. Braun S.A..

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
    1386
  • Date
    2014-05-09
  • 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
    According to the manifestation of the company, the problem can occur when the surgeon moves the baffle, not being possible to do it without damaging the catheter. However, this problem is detectable by the surgeon during implantation. Thus, the risk to the patient is low and detectable. In addition, in most cases of implantation the ventricular-deflector catheter combinations are implanted without deflector movement.////// UPDATE - 07/18/2014 - The company closed the field action and the collected units were returned to the manufacturer.
  • Cause
    The company that holds the registry informs about the possibility of rupture of the ventricular catheter within the baffle. this problem may occur during implantation of the baffle, with the movement of the catheter, since the baffle attaches very strongly to the ventricular catheter. the problem is caused by deviations in the tolerance limit of the external diameter of the ventricular catheter.
  • Action
    The company that holds the registration in Brazil requests the interruption of the distribution of said products / lots, which are still in the customer's stock, segregation thereof, information to Laboratorios B. Braun SA of the quantities of existing units of each product code and number of lot. If the aforementioned products have already been implanted, and the surgeon has noticed that signs that the Shunt is not working properly, we recommend that an investigation be done on these patients.

Device

Ventricular Catheter (AESCULAP ​​HYDROCEPHAL SYSTEM, Registration no. 80136990434 - lot: 45052526...

Manufacturer

Laboratórios B. Braun S.A.