BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1817560 · Received April 14, 2010

    Report

    Report Number
    3004904811-2010-00006
    Event Type
    Other
    Date Received
    April 14, 2010
    Date of Event
    December 30, 2009
    Report Date
    March 15, 2010
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT WITH HIGH-GRADE DYSPLASIA IN A BARRETT'S ESOPHAGUS UNDERWENT CIRCUMFERENTIAL RFA AS PART OF THE (B)(6) REGISTRY AND WAS FOUND TO HAVE A STRICTURE ONE MONTH LATER IN THE TREATED AREA. THIS WAS DILATED SUCCESSFUL FOLLOWED BY FOCAL ABLATION. THE PHYSICIAN GRADED THE SEVERITY OF THIS EVENT AS MODERATE AND NOT RELATED TO ANY DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention