Alerte De Sécurité sur CUTTING BALLOON PERIPHERAL. Registration at ANVISA: 10341350358. Risk Class III - High Risk.

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 Interventional Technologies Europe Ltda.

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
    871
  • Date
    2007-06-12
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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 Boston Scientific do Brasil Ltda, the most important potential clinical effect related to balloon leakage would be a prolongation or delay in the clinical procedure, due to the need to change the balloon and also due to the possibility of the arterotome detachment or twisting of the balloon. balloon folds. For further information regarding the case, check complementary health alert No. 875.
  • Cause
    Possibility of the balloon having a leak at the distal tip or a fault exists to maintain the pressure thereof.
  • Action
    Boston Scientific do Brasil Ltda reported that it communicated all the customers involved, collected all the affected products (57 units collected from customers and 25 units from the own warehouse) and already sent the defective products to its Distribution Center in Kerkrade (Holland). The company sent to UTVIG / ANVISA supporting documentation of the sending of units of the product under suspicion and letter of communication, which contains the information that the company considers that the action of recall of the product in Brazil has already been finalized.

Manufacturer