Events

Alerta De Seguridad para Wallstent Tips Endoprosthesis with Unistep Release System (WALLSTENT® Carotid with Monorail® Delivery System), ANVISA registration no. 10341350226.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific do Brasil Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    834
  • Fecha
    2006-07-17
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to Boston Scientific, so far, it has received no reports of complications or damage associated with this product disability. In addition to the batches reported in this notification, this recall does not affect any other WALLSTENT® Carotid with Monorail® Delivery System. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company. Voluntary Withdrawal Notification Letter: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/834_recall.pdf Verification / Traceability Form to be completed by affected clients: http://www.anvisa.gov. br / technovigilance / alerts / annexes_2006 / 834_formula.pdf
  • Causa
    As of 06/29/2006, boston scientific has received 26 claims related to the inability to irrigate the product release system at the time of rescue. the potential clinical effects associated with this complication include prolongation and delay of the clinical procedure.
  • Acción
    Immediately discontinue use and segregate the units affected by this recall (the attached table provides a complete list of products affected by this recall, including codes, batch numbers, and product descriptions). List of affected products: The distribution or use of products affected by this recall must cease immediately. Corrective measures are being implemented and the replacement of the product is now available. ************************************************ Update on 08/15/2006: Boston Scientific informs that all customers have already been notified and that all affected products have already been collected. In total, 646 units of affected products were collected. http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/834_prod_afetados.pdf

Device

Wallstent Tips Endoprosthesis with Unistep Release System (WALLSTENT® Carotid with Monorail® Deli...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA