Events

Alerte De Sécurité sur SYMMETRY CATETER TALON CATETER DANCING BALLOON DILATATION BALLOON - Reg. Anvisa nº 10341350165

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 Boston Scientific Corporation.

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
    814
  • Date
    2005-09-21
  • 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
    The company Boston Scientific do Brasil informs that these products are no longer part of the marketing strategy of the company and for this reason the expiration of its registration published in DOU of 04/11/05. It emphasizes that in the period of commercialization of these products in Brazil there were no reports of any incident of this type. It is also informed that the FDA has already been notified of the occurrence and that all customers who have purchased the product will be notified by notice. Additional information access: http://www.anvisa.gov.br/divulga/informes/2005/071005_boston.pdf
  • Cause
    Boston scientific corporation received 16 reports distributed in n = 5 of slow deflation and = 11 non-deflation for the 20,000 units of talon product distributed worldwide since the product was introduced in the market five years ago. twelve of these incidents were reported by customers in japan in 2005. likewise, 6 slow-deflation events and 3 non-deflation events were reported for the symmentry product, which has 92,000 units distributed worldwide since its introduction which occurred 5 years ago, were all reported in japan and 7 of them occurred in 2005. in all reported cases the balloons were fit to be deflated by traditional standard methods. none of the patients required medical intervention to remove the balloon. in none of the cases there was an adverse event, complications and extension in the procedure time. investigations of these reports by boston scientific corporation revealed that in at least 3 of the cases, the balloon catheter was intentionally inflated to more than 3 atmospheres ("atm") above the recommended maximum burst pressure ("rbp"). balloon rupture)) as described in the instructions for use of the product. not enough information was available to determine if the balloons were over-inflated in other cases. analyzes of a failed product unit determined the potential cause of the collapse of the thin wall material (crevice) at the tip interface and the inner lumen of the catheter wall. this may have prevented the exit of the insufflation solution from the balloon.
  • Action
    In order to thoroughly investigate the cause of these slow-deflating and non-deflating events, Boston Scientific Corporation conducted an engineering study in which the Talon and Symmetry product balloons were repeatedly inflated to RBP (15 atm) and deflated according to instructions contained in the Instructions for Use. All products tested passed the disinflation / inflation test according to the criteria of the product specification.

Device

SYMMETRY CATETER TALON CATETER DANCING BALLOON DILATATION BALLOON - Reg. Anvisa nº 10341350165

Manufacturer

Boston Scientific Corporation
  • Source
    ANVSANVISA