BEUDAMED
    FDA Adverse Event Other Summary report: N

    HI-TORQUE CROSS-IT 100XT 0.014" 190 CM REF1003309H

    MDR report key: 5027390 · Received August 21, 2015

    Report

    Report Number
    MW5055697
    Event Type
    Other
    Date Received
    August 21, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 10, 2015
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING PTCA OF THE RCA, THE TIP OF THE WIRE BROKE OFF AND BECAME EMBEDDED IN THE SUBINTIMAL CALCIFIED PLAQUE. A FEMORAL APPROACH WAS BEING USED. NO ATTEMPT TO RETRIEVE THE TIP WAS TRIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554518 HI-TORQUE CROSS-IT 100XT 0.014" 190 CM REF1003309H GUIDEWIRE DQX ABBOTT VASCULAR INC. NA 4032801

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR