BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE 5

    MDR report key: 804088 · Received December 4, 2006

    Report

    Report Number
    804088
    Event Type
    Malfunction
    Date Received
    December 4, 2006
    Date of Event
    November 28, 2006
    Report Date
    December 4, 2006
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE PRESSURE WIRE WAS PASSED THROUGH THE GUIDE CATHETER, THE PRESSURE READING KEPT CLIMBING UNTIL IT WENT RIGHT OFF OF THE SCALE. DID NOT CORRELATE WITH ANY DATA. IN TROUBLESHOOTING, A NEW PRESSURE WIRE WAS INSERTED FIRST, AND A NORMAL TRACING PRESSURE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE 5 PRESSURE SENSOR, INTRACORONARY DQX RADI MEDICAL SYSTEMS AB 0.014' (0.36 MM)- 175 CM 061890

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR