BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE SENSOR

    MDR report key: 731693 · Received June 29, 2006

    Report

    Report Number
    8030904-2006-00001
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    June 16, 2006
    Report Date
    June 29, 2006
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN POSITIONING THE PRESSUREWIRE FOR EQUALIZATION OF THE PRESSURE, THE OPERATOR NOTICED THAT THE TIP OF THE WIRE DID NOT RESPOND TO THE MANIPULATION. UPON PULLING OUT THE WIRE, A PART OF THE WIRE (TIP) WAS NOTICED UNDER FLUOROGRAPHY "FLAPPING" INSIDE THE VESSEL. FEARING THAT IT MAY BE WASHED AWAY AND UP TO THE PATIENT'S BRAIN, THE OPERATOR REFERRED THE PATIENT TO AN IMMEDIATE RESCUE OPERATION, WHERE THE DISLODGED PART OF THE WIRE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB * 061130

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R