Events

Alerta De Seguridad para Precise Pro RX Nitinol Stent System (Carotid)

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

¿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
    2016-05-10
  • Fecha de publicación del evento
    2016-05-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160510b.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: cordis precise pro rx nitinol stent system (carotid) medical device manufacturer, cordis corporation, inc. (cordis) has issued a medical device safety alert concerning its precise pro rx nitinol stent system (carotid) [catalog numbers: pc0640xce, pc0730xce, pc0740xce, pc0840xce, pc0930xce and lot numbers: 17344454, 17337067, 17256212, 17308315, 17381651, 17323769, 17314384]. based on recent complaints and subsequent investigation, the manufacturer has determined that products made between 27 apr 2015 and 22 nov 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. product manufactured after 22 nov 2015, including product currently manufactured and supplied are not affected. there have been no patient injuries reported to the manufacturer related to this issue. according to the manufacturer, the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared; vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment; or in most severe cases, transient ischaemic attack or stroke. the manufacturer is voluntarily recalling the affected lots. according to the local supplier, the affected lots are distributed in hong kong. if you are in possession of the affected lots, please contact your supplier for necessary actions. posted on 10 may 2016.

Device

Precise Pro RX Nitinol Stent System (Carotid)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cordis Precise Pro RX Nitinol Stent System (Carotid)
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation