BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE WIRE SENSOR

    MDR report key: 445910 · Received February 21, 2003

    Report

    Report Number
    8030904-2003-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2003
    Date of Event
    February 4, 2003
    Report Date
    February 21, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS CAUGHT IN A VERY CALCIFIED VESSEL WITH SEVERE MORPHOLOGY. THERE WAS A 90 ANGLE AT THE PROXIMAL END OF THE THREE (3) CM LONG TIP. THE PRESSURE WIRE SENSOR WAS CONTINUOUSLY ROTATED BACK AND FORTH (>100 TIMES) FOR SOME 20 MINUTES TO REACH THE TARGET VESSEL. SOMETIMES NO TIP MOVEMENT WAS NOTED EVEN THOUGH THE DEVICE WAS ROTATED PROXIMALLY, POSSIBLY BECAUSE THE TIP WAS STUCK OR CAUGHT. AFTER SUCCESSFUL PRESSURE MEASUREMENTS, THE GUIDEWIRE WAS WITHDRAWN BUT THE TIP DID NOT FOLLOW. THE TIP WAS STILL IN THE VESSEL. THE OPERATOR CAUGHT THE TIP WITH A GOOSE NECK AND WAS ABLE TO TAKE IT OUT. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE WIRE SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 12004 D2096

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention