BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2162271 · Received July 6, 2011

    Report

    Report Number
    3004904811-2011-00023
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BARRX MEDICAL INC
    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 U.S. (B)(6) PATIENT REGISTRY. SUBJECT WAS ENROLLED IN THE REGISTRY HAVING A 6 CM BARRETT'S ESOPHAGUS CONTAINING HIGH-GRADE DYSPLASIA. CIRCUMFERENTIAL ABLATION WAS PERFORMED WITHOUT ADVERSE EVENT. A SERIES OF FOCAL ABLATION PROCEDURES ENSUED, WITH AN INTERVENING ENDOSCOPIC MUCOSAL RESECTION, TO COMPLETELY ERADICATE ALL ABNORMAL TISSUE. A STRICTURE WAS NOTED AFTER THE LAST ENDOSCOPIC MUCOSAL RESECTION AND ABLATION PROCEDURE. THE STRICTURE WAS DILATED. PER THE PHYSICIAN, THE ADVERSE EVENT SEVERITY WAS MILD, 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 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL INC 90-9100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention