BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3032438 · Received March 29, 2013

    Report

    Report Number
    2134070-2013-00070
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    PMA / PMN Number
    K051220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE INSULATION DAMAGED ON THE DISTAL END AND METAL EXPOSED. THE TIP OF THE DEVICE WAS TWISTED. UPON EVALUATION IT WAS FOUND THAT THE DEVICE DID NOT RESPOND TO THE ADJUSTMENT CONTROLS ON THE HANDLE. IT WAS NOTED THAT DURING ELECTRICAL TESTING, THE DEVICE DID NOT PASS A CONTINUITY TEST. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS VISUALLY AND FUNCTIONALLY TESTED PRIOR TO BEING RELEASED, NO CONCLUSION COULD BE MADE REGARDING WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE KINKED INSIDE THE PATIENT WITH BARE METAL SHOWING THROUGH THE COVERING DURING AN ABLATION PROCEDURE. THE CASE WAS ABORTED MID-PROCEDURE. THE PT EXPERIENCED A RIGHT ATRIAL CLOT THAT WAS TREATED WITH IV HEPARIN, AND GROIN TRAUMA THAT WAS TREATED WITH PRESSURE HELD AND NO FURTHER TREATMENT. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE WAS HOME WITH NO COMPLAINTS. THE PT HAD BEEN TAKING COUMADIN AS HOME MEDICATION. THE PT WAS SCHEDULED TO RETURN FOR A REPEAT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130424 NA NLH STERILMED, INC. DAI401932

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R