BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX

    MDR report key: 2073623 · Received April 20, 2011

    Report

    Report Number
    2073623
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ABBOTT
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    STYLET WOULD NOT COME OUT OF END OF THE BALLOON. CARDIOVASCULAR TECHNOLOGIST (CVT) TRIED TO TAKE THE STYLET OUT BUT IT SEEMED TO BE STUCK. THE DOCTOR TRIED TO REMOVE THE STYLET, FORCEFULLY BENT THE END OF THE STYLET AND RIPPED GLOVE, THEREFORE QUESTIONING THE SAFE USE OF THE DEVICE. WE WERE ABLE TO FINISH THE PROCEDURE THERE WERE NO COMPLICATIONS ANOTHER DEVICE WAS USED AND WORKED FINE THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX ABBOTT * 0111862

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR