Events

Alerta De Seguridad para CUTTING BALLOON PERIPHERAL. Registration at ANVISA: 10341350358. Risk Class III - High Risk.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Interventional Technologies Europe 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
    871
  • Fecha
    2007-06-12
  • 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 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.
  • Causa
    Possibility of the balloon having a leak at the distal tip or a fault exists to maintain the pressure thereof.
  • Acción
    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.

Device

CUTTING BALLOON PERIPHERAL. Registration at ANVISA: 10341350358. Risk Class III - High Risk.

Manufacturer

Interventional Technologies Europe Ltda
  • Source
    ANVSANVISA