BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUEPORT, AMPLATZ, 90CM

    MDR report key: 499850 · Received November 25, 2003

    Report

    Report Number
    2951009-2003-00012
    Event Type
    Malfunction
    Date Received
    November 25, 2003
    Date of Event
    October 27, 2003
    Report Date
    November 24, 2003
    Manufacturer
    CARDIMA, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO ACCESS THE "CS", THE DISTAL TIP MARKER BAND CAME OFF OF THE VUEPORT AND CURRENTLY RESIDES IN THE PT'S ATRIUM. PT STABLE, ATTEMPTS MADE TO RETRIEVE BAND WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUEPORT, AMPLATZ, 90CM VUEPORT DQY CARDIMA, INC. 08-002025 M1644

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR