Events

Alerta De Seguridad para Zenith Alpha Thoracic Endovascular Graft

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por William Cook Europe.

¿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
  • Fecha
    2017-03-22
  • Fecha de publicación del evento
    2017-03-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170322b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: william cook europe zenith alpha thoracic endovascular graft abbott vascular has issued a medical device safety alert concerning its nc trek rx coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx ptca balloon catheter. the manufacturer has initiated a voluntary field action regarding specific lots of the nc trek rx coronary dilatation catheter, nc traveler rx coronary dilatation catheter, and nc tenku rx ptca balloon catheter. product from the lots may exhibit difficulty in removing the protective balloon sheath. if excessive force is required to remove the balloon sheath, the sheath may damage the device causing problem with inflating and deflating the balloon. according to the manufacturer, the worldwide frequency of tight sheath removal, inflation and deflation reported events are 0.12%. potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. in one reported case, failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death. this action does not affect patients having successfully undergone cardiac procedures using these devices. the affected users are advised to take the following actions: immediately stop using devices from the affected lots, and return all unused products to the manufacturer for replacement. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 march 2017.

Device

Zenith Alpha Thoracic Endovascular Graft
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
  • Manufacturer
    William Cook Europe

Manufacturer

William Cook Europe