Events

Retiro De Equipo (Recall) de PRECISE PRO RX NITINOL STENT SYSTEM -40MM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH CANADA 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
    53524
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Based on recent complaints and subsequent investigation cordis has determined that products made between april 27 2015 and november 22 2015 have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment. product manufactured after november 22 2015 including product currently manufactured and supplied are not affected. there have been no patient injuries reported to us related to this issue. however considering the products risk analysis the potential impact of inability to deploy the stent or partial stent deployment include an intra-procedural delay while a replacement device is prepared vessel damage requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment or in most severe cases transient ischemic attack or stroke.

Device

PRECISE PRO RX NITINOL STENT SYSTEM -40MM
  • Modelo / Serial
    Model Catalog: PC1040XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0740XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0840XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0940XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0640XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0540XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0720XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0820XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC1030XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0930XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0830XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0730XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0630XCE (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Descripción del producto
    PRECISE PRO RX NITINOL STENT SYSTEM -40MM;PRECISE PRO RX NITINOL STENT SYSTEM - 20MM;PRECISE PRO RX NITINOL STENT SYSTEM - 30MM
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC