BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3960153 · Received June 24, 2014

    Report

    Report Number
    2134070-2014-00126
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 1, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    PMA / PMN Number
    K101789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION, BUT IN A DEFLECTED POSITION. UPON EVALUATION, IT WAS DETERMINED THAT THE STEERING MECHANISM DID NOT ACTUATE THE END OF THE CATHETER AT ALL, AND THE CATHETER WAS STUCK IN THE DEFLECTED POSITION AT APPROXIMATELY A 90 DEGREE TURN. THE CONTROLS MOVED BACK AND FORTH IN THEIR OPERATION EASILY, BUT THE TIP DID NOT RESPOND. THE DISTAL END RETAINED THE CAPABILITY TO ALTER ITS LASSO SIZE, ACHIEVING BOTH MINIMUM AND MAXIMUM RADII. THE DEVICE PASSED BOTH CONTINUITY AND ISOLATION TESTING. THE DHR WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE THE DEVICE DID NOT STEER PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON INVESTIGATION. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367170 NA NLH STERILMED, INC. IRV81687 1729840

    Patients

    Seq Age Sex Outcome Treatment
    1