Events

Alerta De Seguridad para Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERIPHERAL ANGIOPLASTY ANVISA Registration Number: 10349000474 Hazard Class: II Affected Model: AB18W030200150

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; ev3 Inc..

¿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
    2120
  • Fecha
    2016-08-30
  • 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
    There is no need for action with the patient. Patients who received treatment with an OTW Dilatation Catheter for 0.018 "PowerCross ™ PTA affected by this recall should continue to be monitored according to standard practice.
  • Causa
    Auto suture is conducting a voluntary recall of two lots of otw dilatation catheter for pta powercross ™ 0.018 ". this recall was initiated for model ab18w030200150 and is limited to lot numbers a213373 and a216702. this voluntary recall is being initiated due to the identification of a divergence in the description of the size of the balloon. where these affected units, which have a true size of the 3 x 200 mm balloon, are incorrectly marked on the product itself, specifically in the area of ​​tension relief, such as 2.5 x 150 mm (as shown in the enclosed customer letter ). the correct labeling (3 x 200 mm) for the actual size of the balloon is included in the outer carton as well as the inner packaging of the affected devices.
  • Acción
    Field Action Code FA Recall PowerCross triggered under the responsibility of the company AUTO SUTURE DO BRASIL LTDA. Company will collect for further destruction.

Device

Trade name: POWERCROSS DILATATION CATHETER 0.018 OTW PTA Technical name: CATETER BALLOON FOR PERI...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; ev3 Inc.
  • 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