BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2439619 · Received January 12, 2012

    Report

    Report Number
    3004904811-2011-00066
    Event Type
    Other
    Date Received
    January 12, 2012
    Date of Event
    July 5, 2011
    Report Date
    December 13, 2011
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVEN RECORDED ON A CRF AS PART OF THE US RFA REGISTRY FOR BARRETT'S ESOPHAGUS. THIS PT WAS ENROLLED WITH A 3 CM NON-DYSPLASTIC BARRETT'S ESOPHAGUS. AFTER A SECONDARY FOCAL ABLATION PT WAS OBSERVED TO HAVE A MODERATE STRICTURE WHICH WAS DILATED WITH SOME HEMOSTASIS. PT TOLERATED PROCEDURE WELL AND WAS REASSURED. PER THE PHYSICIAN THE SEVERITY OF THIS EVENT WAS MILD AND RELATIONSHIP OF THE EVENT TO THE DEVICE PROCEDURE WAS NOT RELATED AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER LPB BARRX MEDICAL, INCORPORATED 90-9100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention