BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE WIRE SENSOR

    MDR report key: 446446 · Received February 26, 2003

    Report

    Report Number
    8030904-2003-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2003
    Date of Event
    February 7, 2003
    Report Date
    February 25, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "PRESSURE MEASURMENTS AND ULTRASOUND MEASUREMENTS PEFORMED WITHOUT ANY PROBLEMS. AT THE END OF THE EXAMINATION WHEN THE IVUS CAHTETER SHOULD BE WITHDRAWN, THE TIP OF THE PRESSURE WIRE SENSOR WAS CAUGHT IN THE DISTAL PART OF THE IVUS CATHETER. THE DR. COULD NOT ADVANCE OR WITHDRAW THE PRESSURE WIRE SENSOR. THE DR. THEN DECIDED TO WITHDRAW BOTH CATHETER AND PRESSURE WIRE SENSOR AT THE SAME TIME. THE TIP OF THE PRESSURE WIRE SENSOR WAS DETACHED AND TRAPPED IN THE IVUS CATHETER. 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 D2080

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR (IVUS).| BOSTON SCIENTIFICS ATLANTIS SR PLUS CATHETER