Events

Retiro De Equipo (Recall) de Device Recall PowerCross .018 OTW PTA Dilation Catheter

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 Inc.

¿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
    75780
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0892-2017
  • Fecha de inicio del evento
    2016-11-10
  • Fecha de publicación del evento
    2016-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151248
  • 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, angioplasty, peripheral, transluminal - Product Code LIT
  • Causa
    Medtronic identified an issue with specific models and lots of the powercross .018 over the wire (otw) percutaneous transluminal angioplasty (pta) dilatation catheter. during an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. the catheter outer shafts were pinched and deformed at the proximal balloon bond. bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
  • Acción
    Medtronic verbally communicated about the issue on November 20. 2016, to affected customers. Additionally, consignees were hand delivered by Field Sales Representatives a Medtronic "Urgent Medical Device Recall" letter dated November 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to immediately identify, quarantine the affected product, and return it to Medtronic. Requested consignees to complete and email the Customer Confirmation Certificate to RS.CFQFCA@medtronic.com or fax it to Medtronic at 651-367-0612, attention: Customer Focused Quality. For questions, contact your Medtronic representative. If you require assistance in contacting your representative, please contact Medtronics National Answering Service at 800-633-8766.

Device

Device Recall PowerCross .018 OTW PTA Dilation Catheter
  • Modelo / Serial
    UDI/Product Lot/Serial Product Number UPN/GTIN Number 00821684046647 A358626 AB18W030100150 00821684046883 A357386 AB18W060100150 00821684046722 A357070 AB18W040100150 00821684046777 A358043 AB18W050040150 00821684046722 A356360 AB18W040100150 00821684046777 A357348 AB18W050040150 00821684046562 A359219 AB18W025040150
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    NY, NC, WA
  • Descripción del producto
    ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. || The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Dirección del fabricante
    Medtronic Inc, 710 Medtronic Pkwy, NE Mailstop LS245, Minneapolis MN 55432-5603
  • 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