BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER 16, 2-6-2, 135

    MDR report key: 499828 · Received November 25, 2003

    Report

    Report Number
    2951009-2003-00011
    Event Type
    Malfunction
    Date Received
    November 25, 2003
    Date of Event
    October 21, 2003
    Report Date
    November 24, 2003
    Manufacturer
    CARDIMA, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN INSERTED A PATHFINDER 16 INTO THE "CS" USING A VENAPORT D90, THE SHAPE OF THE PLATINUM COIL CHANGED. THE PHYSICIAN CONTINUED THE PROCEDURE WITH THE CHANGED SHAPE AND THE COIL CAME OFF. THE PLATINUM COIL WAS RETRIEVED AND THERE WERE NO PROBLEMS WITH THE PT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER 16, 2-6-2, 135 PATHFINDER DRF CARDIMA, INC. 01-161002 M1809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN