Events

Alerta De Seguridad para Five products affected by the Field Action. 1. PIPELINE EMBOLIZING DEVICE - Registration 10349000471 - Technical Name: ANEURISMA IMPLANT - Risk Class IV ;. 2. ALLIGATOR RECOVERY DEVICE - Registration 10349000457 - Technical Name: DEVICES - Risk Class IV ;. 3. HYDROFILIC GUIDE X-CELERATOR - Registration 10349000313 - Technical Name: FIO CARDIOVASCULAR GUIDE - Risk Class II ;. 4. ULTRAFLOW HPC FLOW ORIENTED MICROCATETER - Record 10349000461 - Technical Name: INTRAVASCULAR MICROPHYDRUS CATETER - Risk Class IV ;. 5. MARATHON MICRO CATHETER FLOW DIRECTED - Record 10349000478 - Technical Name: INTRAVASCULAR MICROPHEPER CATHETER - Risk Class IV ;. Affected lots: Products manufactured between August 2014 and September 2016

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AUTO SUTURE DO BRASIL LTDA; Micro Therapeutics, Inc. - d/b/a ev3 Neurovascular.

¿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
    2012
  • Fecha
    2016-10-05
  • 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
    Recommendations for users and patients: For affected products that have been used, no action is necessary and patients should continue to be monitored in accordance with the patient's protocol of conduct. If the products affected by the recall have not been used, the customer must immediately take the following actions: 1. Remove and quarantine all unaffected products in inventory. 2. Return potentially affected products to Medtronic. #### UPDATED ON 7/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the client and collection of the equipment informed.
  • Causa
    Medtronic has identified a potential problem with a specific batch number group of medtronic neurovascular products, as noted below, where the ptfe (polytetrafluoroethylene) coating could delaminate and separate from the shaft. as a result, we are recalling the products listed in appendix 1 of the attached letter to the customer. this problem affects batches of the following medtronic products manufactured between august 2014 and september 2016: 1. pipeline ™ embolization device 2. alligator ™ recovery device 3. marathon flow directed micro catheter (with chuck) 4. flow oriented microcateter ultraflow hpc (with chuck) 5. xcelerator ™ hydrophilic guidewire.
  • Acción
    Field Action Code FA 740 triggered under the responsibility of the company AUTO SUTURE DO BRASIL LTDA. Company is performing the collection of products that have not been used for later return to the manufacturer.

Device

Five products affected by the Field Action. 1. PIPELINE EMBOLIZING DEVICE - Registration 10349000...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Micro Therapeutics, Inc. - d/b/a ev3 Neurovascular
  • 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