Events

Alerta De Seguridad para SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)

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

¿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
    2012-04-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120412.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: idev technologies supera veritas® interwoven self-expanding nitinol stent peripheral vascular system (6f and 7f) the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the supera veritas® interwoven self-expanding nitinol stent peripheral vascular system (6f and 7f), manufactured by idev technologies. according to the manufacturer, there were reports of a rare event in which the catheter tip was pulled off during use. the manufacturer has determined that the failure to adhere to the instructions for use appeared to be the root cause of these events. specifically, if the thumb slide on the catheter handle is not retracted and locked prior to catheter withdrawal, per the instructions for use, the catheter tip may catch on the introducer sheath and may be pulled off the catheter body. removal of the detached tip may be necessary, as determined by the physician. to date, the manufacturer is not aware of these incidents occurring when the instructions for use are followed and, no injuries have been reported. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)
  • Manufacturer
    IDEV Technologies

Manufacturer

IDEV Technologies
  • 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
    DH