Events

Alerta De Seguridad para JETSTREAM Atherectomy Catheters

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

¿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
    2017-04-18
  • Fecha de publicación del evento
    2017-04-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170418b.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: boston scientific jetstream atherectomy catheters medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its jetstream atherectomy catheters. the manufacturer is initiating a voluntary removal of two lots of jetstream sc 1.85mm [material numbers: 112262-001, 112262-003; lot numbers: 18775553, 18775552; expiration date: 24 december 2017] and one lot of jetstream xc 2.1mm [material number: 112264-001; lot number: 18822086; expiration date: 24 december 2017] atherectomy catheters due to these units being mislabeled. some 1.85mm jetstream sc catheters may have been labeled as 2.1mm catheters, and some 2.1mm jetstream xc catheters may have been labeled as 1.85mm catheters. the affected units that were distributed between january and september 2016 are labeled as bayer product. according to the manufacturer, the most reasonably foreseeable consequence of this situation would be an insignificant prolongation of the procedure to exchange the device for another. there have been no reported patient adverse events as a result of this issue. the affected users are advised to immediately remove all affected products from their inventory (whether in central service, shipping and receiving, or any other location) and segregate the affected products in a secure location for return to the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2017.

Device

JETSTREAM Atherectomy Catheters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific JETSTREAM Atherectomy Catheters
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH