BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2534582 · Received April 10, 2012

    Report

    Report Number
    MW5024984
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Date of Event
    March 31, 2012
    Report Date
    April 3, 2012
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A COMPLEX PERCUTANEOUS INTERVENTION OF THE RCA, WHEN THE GUIDEWIRE DISTAL TIP FRACTURED. AN ATTEMPT WAS MADE TO SNARE THE FRACTURED GUIDEWIRE AND WAS UNSUCCESSFUL. A STENT WAS PERFORMED TO TRAP THE FRACTURED GUIDEWIRE WITH A (10MM) SEGMENT MIGRATING INTO THE DISTAL RCA BRANCH OTHERWISE, THE REMAINDER OF THE GUIDEWIRE WAS TRAPPED BY STENTS. PT REMAINED HEMODYNAMICALLY STABLE AT THE END OF THE PROCEDURE. NO EKG CHANGES OR COMPLAINTS OF CHEST PAIN. POST EVENT PT TRANSFERRED TO FLOOR IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR WHISPER MS HI-TORQUE GUIDEWIRE DQX ABBOTT VASCULAR 1120771

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other