Alerta De Seguridad para Trade name: Disposable Barrx. Technical Name: Radiofrequency Tips for Surgery. ANVISA registration number: 10349000491. Risk class: III. Affected Model: 64082. Affected Batches / Series Numbers: F2502807X; F2503073X; F2503284X;

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.; Covidien LLC.

¿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
    What the user should do for these two situations: 1) When using the Barrx ™ 360 express RFA balloon catheter, position and move the balloon catheter under direct endoscopic visualization. During withdrawal, observe the balloon and electrode in relation to any interaction with the esophageal tissue to ensure atraumatic removal. Do not feed or retract the catheter if excessive resistance is encountered. Observe the other instructions and warnings mentioned in the Instructions for Use and in Annex A; 2) When using the Barrx ™ 360 express RFA balloon catheter, do not omit the esophageal cleaning and catheter cleaning step between the two esophageal ablations. Observe the other instructions and warnings mentioned in the Instructions for Use and in Annex B; 3) When using the Barrx ™ 360 express RFA balloon catheter, follow all instructions for use to reduce the likelihood of complications; 4) Ensure that those using the Barrx ™ 360 express RFA balloon catheter are familiar with the recommended use instructions and procedure steps outlined in the Use Instruction; 5) Complete the Confirmation Form sent by the company. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/29/2018 - Date of notification notice for Anvisa: 05/04/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    The manufacturer was aware of two situations using the product rfa barrx ™ 360 express rfa balloon catheter in a manner inconsistent with the instructions for use (normal use), resulting in adverse events - including three esophageal perforations (the first abnormal use situation) . the safety warning issued by the company aims to reinforce the information contained in the instructions for use.
  • Acción
    Field Action Code FA Barrx 360 triggered under the responsibility of the company Auto Suture do Brasil Ltda. Updating, correcting or supplementing the instructions for use.


  • Empresa matriz del fabricante (2017)
  • 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