Events

Alerta De Seguridad para Archer 0.035 inch (0.89mm) Super Stiff Guidewire

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

¿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
    2013-03-22
  • Fecha de publicación del evento
    2013-03-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130322a.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: medtronic archer 0.035 inch (0.89mm) super stiff guidewire medical device manufacturer,medtronic inc., has initiated a medical device field safety correction action concerning specific lot numbers of the medtronic archer 0.035 inch (0.89mm) super stiff guidewire, models arcsj200w, arcsj260w and arcdj260w. medtronic has identified an issue involving the affected products, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. as a result, medtronicis recalling the affected guidewires. as of 1 feb, 2013, medtronic has received 9 reports involving 14 guidewires related to this issue; 4 of these reports involved serious injury.There were no patient deaths and no additional reported clinical sequelae related to these reports. in hong kong, the local supplierhas not been aware of any adverse incident related to the above mentioned issue. based on these reports, the overall failure rate of affected guidewires is approximately 0.1% for the kinking or breaking in-vivo.Corrective actions to the manufacturing process have been taken to prevent recurrenceof this issue in subsequent production. the manufacturer advises that patients should continue to be managed in accordance with the standard patient management protocol andthe guidewireinstruction foruse. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 march 2013.

Device

Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH