Events

Alerta De Seguridad para SUPER TORQUE® MB Angiographic Catheter

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

¿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
    2011-11-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111129a.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
    Field safety notice: cordis super torque® mb angiographic catheter medical device manufacturer, cordis, has issued a field safety notice related to a specific subgroup of cordis angiographic catheters, super torque® mb angiographic catheter. manipulation of the super torque® mb angiographic catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter. stretching or elongation of the super torque® mb angiographic catheter during endovascular procedures could result in the marker bands moving along the catheter. in extreme cases, marker bands may come off the super torque® mb angiographic catheter and dislodge into the vascular system. movement of the marker bands can result in inaccurate reference and device sizing. dislodgement of the marker bands into the vascular system can result in additional intervention, embolism, thrombosis, or other vascular complications. the manufacturer is in the process of updating the product labeling. according to local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

SUPER TORQUE® MB Angiographic Catheter
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cordis SUPER TORQUER MB Angiographic Catheter
  • Manufacturer
    Cordis

Manufacturer

Cordis