BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 2162269 · Received July 6, 2011

    Report

    Report Number
    3004904811-2011-00025
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BARRX MEDICAL INC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A (B)(4) AS PART OF THE U.S. (B)(4) PATIENT REGISTRY. SUBJECT WAS ENROLLED IN THE REGISTRY HAVING A BARRETT'S ESOPHAGUS CONTAINING LOW-GRADE DYSPLASIA. CIRCUMFERENTIAL ABLATION WAS PERFORMED WITHOUT ACUTE ADVERSE EVENT. AT ONE MONTH, THE PATIENT WAS NOTED TO HAVE A MODERATE STRICTURE OF THE ESOPHAGUS, WHICH WAS DILATED ONCE. NO INFORMATION IS YET AVAILABLE REGARDING RESOLUTION OF THE STRICTURE. PER THE PHYSICIAN, THE ADVERSE EVENT SEVERITY WAS MODERATE, THE RELATIONSHIP TO THE ABLATION DEVICE WAS POSSIBLE, AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention