Events

Retiro De Equipo (Recall) de Device Recall Spectranetics TurboElite Laser Atherectomy Catheters

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 Spectranetics Corporation.

¿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
    77474
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2863-2017
  • Fecha de inicio del evento
    2017-06-06
  • Fecha de publicación del evento
    2017-07-14
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156104
  • 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
    Catheter, peripheral, atherectomy - Product Code MCW
  • Causa
    Potential for flouroscopially visible marker band at the tip of the rapid exchange turbo elite atherectomy catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
  • Acción
    Spectranetics sent a Field Safety Notice letter via certified mail on June 7, 2017, to all customers who have ordered the affected model numbers since 23May2016 reiterating the risks associated with off-label use of the device (i.e., not activating the laser within a stent and not until all contrast media is flushed from the treatment area). The product continues to meet specifications and does not need to be returned. Customers with questions were encouraged to call their local Spectranetics Sales Representative or Spectranetics Customer Service Department. Customer Service can be reached by phone at 800-231-0978 (Option 2), by fax at 877-447-2022, or by email at customer.service@spnc.com. Customer Service is available Monday thru Friday, From 7AM-5PM MST.

Device

Device Recall Spectranetics TurboElite Laser Atherectomy Catheters
  • Modelo / Serial
    Model Number 414-159 Catheter Diameter 1.4mm,  Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
  • Descripción del producto
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters || Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
  • Manufacturer
    Spectranetics Corporation

Manufacturer

Spectranetics Corporation
  • Dirección del fabricante
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA