Events

Safety Alert for Filterwire EZ System, Anvisa Registry # 10341350378, lots # 729905, 730208, 730316, 731207, 731905, 803705, 803712, 805203, 805704, 806405, 806605, 807008, 807205, 807905, 728206, 731007, 731704, 731809, 807108, 731901 , 803510, 803602, 803602, 805603, 730903, 728107,728212, 730406, 730505, 731101, 731201, 731610, 802806, 802904, 803605, 804505, 805007, 805105, 805902, 806310, 806507, 806602, 807902, 808004, 808501, 808602 , 731004, 731803, 805701.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    922
  • Date
    2008-06-06
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    ATTENTION: NO PRODUCT IS BEING REMOVED FROM THE MARKET, SO IT IS NOT NECESSARY TO RETURN ANY PRODUCT TO BOSTON SCIENTIFIC OF BRAZIL LTDA. The batches affected are also described in the document available at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_922_lotes.pdf. #### Update (09/03/2009): The holder of the product registration informed (on 10/20/2008) the UTVIG / Anvisa that finalized this action.
  • Reason
    Boston scientific has identified that the 48 lots listed above may not display the instructions for use inside their packaging. this fact may lead to a delay in the surgical procedure, which may result in risk to the patient, since the user will need to look for the use instructions in the other product box. so far, boston scientific has not received any complaint claiming the absence of the instructions for use. boston scientific has sent the following letter warning about the problem: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2008/ alert_922_carta.Pdf.
  • Action
    1. IMMEDIATELY INSPECT ALL PRODUCTS MENTIONED IN THIS NOTIFICATION: - Immediately identify all batches affected by this action in your inventory (and also from the Rooms of Special Procedures, Interventional Radiology, Operating Room, Hemodynamics, Central Service, Shipment, Receipt or any another location). - Segregate these products and verify the presence of the Instructions for Use on the packaging. - If you find units that do not have Instructions for Use, quarantine them until Boston Scientific provides them with a replacement. 2. COMPLETE AND RETURN THE VERIFICATION / TRACEABILITY FORM: - Complete the Verification / Traceability Form (even if you do not have any affected units in your inventory), following the instructions on the form itself at http://www.anvisa.com Return to the Verification / Traceability Form for: RENATA BRANDÃO Fax: (11) 5502 - 8510.

Device

Filterwire EZ System, Anvisa Registry # 10341350378, lots # 729905, 730208, 730316, 731207, 73190...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA