Events

Alerta De Seguridad para Jagwire Straight and Angle Tip High Performance Guidewire

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
    2016-01-04
  • Fecha de publicación del evento
    2016-01-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160104.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
    Boston scientific jagwire straight and angle tip high performance guidewire medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its jagwire straight and angle tip high performance guidewire. the affected products are identified as follows: jagwire straight tip high performance guidewire; material number: m00556581, m00556561, m00556601, m00556621, m00556641, m0055656011, m0055658011, m0055660011 and m0055662011 jagwire angle tip high performance guidewire; material number: m005566101, m00556591, m00556611 and m0055659011 jagwire angle tip high performance extendable guidewire material number: m00556931 the manufacturer is implementing a voluntary medical device recall removal for specific lots of the affected products in china only, because there was an increase in the rate of complaints about tip detachment of the affected products being reported from china between october and november of 2015. according to the manufacturer, this increase was caused by the implementation of an over-pouching process in china. investigation revealed that this process increased the rate of tip detachment by trapping moisture present during shipping and storage in high humidity conditions within the pouch. the tip detachment could lead to device fragments left behind inside the biliary system which would pass naturally or potentially perforation due to exposed underlying guidewire. as at 28 december 2015, no serious injuries have been reported. the manufacturer instructs the affected users to take the following actions:- immediately discontinue use of and segregate recalled product. complete and return the account reply verification tracking form package/ship the recalled product. 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 4 january 2016.

Device

Jagwire Straight and Angle Tip High Performance Guidewire
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Boston Scientific Jagwire Straight and Angle Tip High Performance Guidewire
  • 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