Events

Retiro De Equipo (Recall) de Device Recall Snap Shunt Ventricular Catheter, Standard, with BioGlide

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Neurosurgery.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    51287
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1138-2009
  • Fecha de inicio del evento
    2009-02-12
  • Fecha de publicación del evento
    2009-03-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79650
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Central Nervous System Shunt and Components - Product Code JXG
  • Causa
    The ventricular catheters may become detached from the snap base assembly after implantation and this condition may increase the need for emergency revision surgery.
  • Acción
    An Urgent - Medical Device Recall notification was sent on February 13,2009 to the attention of risk managers, advising them to cease use of the Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782 ( all versions and all lot numbers), the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27802 ( all versions and all lot numbers), and the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27708 ( all version and all lot numbers). Each customer is to cease the use of the listed product and any unused unit needs to be returned to Medtronic. Further, each account is required to account for product used/implanted and to advise surgeons of the recall information. Each account will recieved an individualized Customer Product Reconciliation Form provided by their Medtronic Sales Representative for determining the status of any product shipped to them.

Device

Device Recall Snap Shunt Ventricular Catheter, Standard, with BioGlide
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, Ireland, and Australia.
  • Descripción del producto
    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Dirección del fabricante
    Medtronic Neurosurgery, 125-B Cremona Dr, Goleta CA 93117
  • 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
    USFDA