Events

Alerta De Seguridad para Guider Softip Guiding Catheter

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines 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
  • Número del evento
    2018-045
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/488564-fda-advisory-no-2018-045
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2018-045  voluntary product recall of guider softip guiding catheter all concerned healthcare professionals and establishments are hereby advised by the food and drug administration (fda) regarding the voluntary product recall of specific lots of guider softip guiding catheter with dvr no. 4230 (see photos of the product below), distributed and imported by partners’ choicemed, inc. description lot no. guider/ 40 deg xf /7fr/ 9cm   19793264 18056772 20013730 20601623 17987235 17997088 19791829 20471803 18056695 19787277 20144784 20601934 18116710 20471804 description lot no. guider/ 40 xf /8f/ 90cm   19157528 19159673 partners’ choicemed, inc. received a notice of product recall from stryker neurovascular, in coordination with boston scientific the manufacturer of the above-mentioned medical device product. stryker neurovascular has become aware that the above-mentioned lots of guider 7f and 8f product may be at risk of degrading within its shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017. patients previously treated with the impacted devices are not at risk. for potential patients, the reported issue can cause the embolization of degraded polymer fragments into the neurovasculature which can cause stroke. there have been no reports of catheter degradation or injury. all concerned healthcare professionals and establishments are advised to discontinue further use, sale and distribution of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2018-045.Pdf.

Device

Guider Softip Guiding Catheter

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
    FDAP