Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1386
  • Date
    2014-05-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.