Alerta De Seguridad para CUTTING BALLOON PERIPHERAL - Registro ANVISA Nº 10341350358

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 LIMITED, BOSTON SCIENTIFIC INTERNATIONAL B V, BOSTON SCIENTIFIC CORPORATION.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The company reports that the most important potential clinical effect related to balloon leakage is to prolong or delay the clinical procedure because of the need to change the balloon. The company also reports that although the likelihood of these failures is rare, they are possible, especially if the physician chooses to use the product in a different way from the Instructions for Use of the Product. The most serious damage expected from the outcome of this type of event is venous damage or an embolic event, which may result in the need for additional surgical procedures. The Anvisa Technovigilance unit is following up on this case. #### Update on 09/20/2007: The company Boston Ltda informed, in communication to Anvisa (file no. 242614/075, dated May 2, 2007) , that all affected products were collected (82 units, according to the company) and sent to the company's distribution center in the Netherlands for analysis. For further information, access alert no. 871.
  • Causa
    It has been found through analysis that the balloon may leak at the distal tip or otherwise there is the possibility of a failure to maintain the pressure. identified that this could be potential for the detachment of the arterotome or twisting of the folds of the balloon of the product.////// - see list of products affected (codes and lots) cutting balloon peripheral- let-2006-06-6364-fa , through the link: http: //www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2007/875.Pdf.
  • Acción
    1. Immediately discontinue use and segregate units affected by this action - Immediately remove all batches affected by this action from your inventory (and also from the Special Procedures Rooms, Interventional Radiology, OR, Hemodynamics, Central Service, Shipping, Receiving, or any other location). - Segregate the affected units in a safe place and return them to Boston Scientific of Brazil. The Company makes clear that the distribution or use of any remaining product affected by this Voluntary Product Medical Product Withdrawal must be terminated immediately. Replacement of these products is not available at the moment, however, a credit will be generated for all returned products. 2. Complete and return the Verification / Traceability Form - Complete the Verification / Traceability Form (even if you do not have any units to return), following the instructions on this page and the form itself. - Return all pages of the Verification / Traceability Form to BOSTON SCIENTIFIC DO BRASIL LTDA (11) 5502-8510 3. Packaging and Return of affected products - Pack the products to be returned in an appropriate box; - Identify the box with the customer's name; - Seal the carton and return it to Boston Scientific of Brazil: