Events

Alerta De Seguridad para Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

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

¿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
    2016-02-26
  • Fecha de publicación del evento
    2016-02-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160226.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: arrow intra-aortic balloon catheter kits and percutaneous insertion kits the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning arrow intra-aortic balloon catheter kits and percutaneous insertion kits manufactured by arrow international, inc. the arrow intra-aortic balloon catheter kits and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the issue pertains to the sheath introducer in the insertion kit only. the other components of the kits are unaffected. the manufacturer has advised there is the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. in addition, delay of treatment, interruption of treatment, or loss of intra-aortic balloon therapy can occur. the manufacturer is advising customers to immediately quarantine all affected kits. the manufacturer will deliver replacement kits to the affected customers before the recovery of the affected kit. the manufacturer advises users that in the case of an emergency situation before the replacement kit can be delivered, the arrow intra-aortic balloon catheter can be inserted through the following alternative 8 fr. sheaths: -st jude medical diag maximum -terumo pinnacle -cordis avanti for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00204-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 26 february 2016.

Device

Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medical Device Safety Alert: ARROW Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
  • Manufacturer
    Arrow International

Manufacturer

Arrow International