BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 2162247 · Received July 6, 2011

    Report

    Report Number
    3004904811-2011-00026
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    May 17, 2010
    Report Date
    June 13, 2011
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 PATHOLOGY THAT WAS INDEFINITE FOR DYSPLASIA. CIRCUMFERENTIAL ABLATION WAS PERFORMED. THREE MONTHS LATER, THE PATIENT WAS NOTED TO HAVE AN ESOPHAGEAL STRICTURE. THE STRICTURE WAS DILATED ENDOSCOPICALLY ON FOUR OCCASIONS AND UPON THE LAST VISIT, WAS NOTED TO BE RESOLVED. PER THE PHYSICIAN, THE ADVERSE EVENT SEVERITY WAS MODERATE, THE RELATIONSHIP TO THE ABLATION DEVICE WAS DEFINITE, 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 67 YR Required Intervention