Events

Alerta De Seguridad para PIPELINE EMBOLIZING DEVICE - Registration 80301610006 - MODELS / LOTS AFFECTED: VIDE ANNEX .. http://portal.anvisa.gov.br/wps/wcm/connect/f4094c804e37c340a02cb3c09d49251b/Lote_Afetados_no_Brasil.pdf?MOD=AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EV3 COMÉRCIO DE PRODUTOS ENDOVASCULARES 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
    1224
  • Fecha
    2013-01-17
  • 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
    The company clarifies that such difficulties usually occur in patients with tortuous or restrictive anatomy. Therefore, patient selection and device use following the guidelines outlined in the Instructions for Use are critical. Anvisa follows this Field Action. See attached Customer Letter. http://portal.anvisa.gov.br/wps/wcm/connect/1b2139004e37c2c3a023b3c09d49251b/Carta_ao_Cliente.pdf?MOD=AJPERES####ERRORAMENTO - 03/12/2013 - The company forwards the Report of Completion of the Field Action, having communicated all its clients. ####
  • Causa
    The device may not readily disengage from the capture / protection coil and may not open completely and attach to the wall of the vessel. see attached customer letter. http://en.Wikipedia.Org/w/index.Php/.
  • Acción
    The company recommends to users that: If there is excessive friction during insertion of the supply system at any time during the use of the PED, carefully remove the whole system simultaneously (microcatheter and delivery system). See attached Customer Letter. http://en.wikipedia.org/w/index.php/

Device

PIPELINE EMBOLIZING DEVICE - Registration 80301610006 - MODELS / LOTS AFFECTED: VIDE ANNEX .. htt...

Manufacturer

EV3 COMÉRCIO DE PRODUTOS ENDOVASCULARES DO BRASIL LTDA.
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA