Events

Alerta De Seguridad para Clip Delivery System - Mitraclip System, model CDS02ST, registration 80146501877, Risk class IV. The following lots are in stock at Abbott Vascular: 50930U101, 50930U102. 50930U103, 50930U104, 50930U105, 50930U106, 50930U107, 50930U108, 50930U110, 50930U111, 50930U112, 50930U113, 50930U115, 50930U116, 50930U117, 50930U118, 50930U119, 50930U126, 50930U132, 50930U129, 50930U128, 50930U131, 50930U130, 50930U127, 50930U133, 50930U134, 51118U106, 51118U113, 51118U119, 51118U128.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Evalve 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
    1815
  • Fecha
    2016-02-04
  • 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
    Cases reported as serious adverse events resulted in surgical interventions and, in one case, the patient died after the operation due to severe comorbidities. After investigating the case, Abbott Vascular has determined that a chuck fracture may occur if stress is exerted on the Single-Directional Knob to implant the Clip. Tension occurs if the Arm Positioner is not in Neutral position during clip release.
  • Causa
    Nine case reports related to the single-directional pushbutton clip delivery system device (batch number 50714u1 and above) according to which the user attempted to deploy a mitraclip but could not remove the clip from the delivery system due to a fracture in the mandrel. the chuck is an internal component of the clip delivery system, integral to the operation and deployment of the clip. after investigating the case, abbott vascular has determined that a chuck fracture may occur if stress is exerted on the single-directional drive knob to implant the clip.
  • Acción
    Safety notice. Change of Instructions for Use. Action Code: February 4, 2016. As long as the user follows the procedure described in the revised instructions for use contained in the notice of this field action, there are no consequences for the use of products at risk. It should be noted that in addition to this statement, Abbott Vascular has a trained professional to follow all the procedures that involve the use of the product in Brazil, ensuring the correct use by the physician, according to the new instructions.

Device

Clip Delivery System - Mitraclip System, model CDS02ST, registration 80146501877, Risk class IV. ...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Evalve Inc.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA