BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 1790580 · Received August 3, 2010

    Report

    Report Number
    3004904811-2010-00042
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    June 14, 2010
    Report Date
    July 4, 2010
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CRF AS PART OF THE (B)(6) PT REGISTRY FOR A PT WITH BARRETT'S ESOPHAGUS TREATED WITH FOCAL ABLATION. AT 2 MONTHS FOLLOW-UP, PT NOTED TO HAVE A MILD STRICTURE WHICH WAS DILATED SUCCESSFULLY. AFTER ONE DILATATION, SYMPTOMS RESOLVED AND STRICTURE NO LONGER NOTED. PHYSICIAN DEEMED THIS EVENT SEVERITY AS MILD, DEFINITELY RELATED TO THE ABLATION, AND NOT RELATED TO ANY MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention