BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX.014"/205 FLOPPY

    MDR report key: 503784 · Received December 11, 2003

    Report

    Report Number
    6000078-2003-00225
    Event Type
    Malfunction
    Date Received
    December 11, 2003
    Date of Event
    October 21, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION NEUROVASCULAR DIVISION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX.014"/205 FLOPPY GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION NEUROVASCULAR DIVISION * 5877283

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO RENEGADE CATHETER, GUIDER GUIDE CATHETER.