BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2439612 · Received January 12, 2012

    Report

    Report Number
    3004904811-2011-00068
    Event Type
    Other
    Date Received
    January 12, 2012
    Date of Event
    August 25, 2011
    Report Date
    December 13, 2011
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CRF AS PART OF THE US RFA REGISTRY FOR BARRETT'S ESOPHAGUS. THIS PT WAS ENROLLED WITH A 3 CM LOW GRADE DYSPLASIA. AFTER A SECONDARY FOCAL ABLATION THE PT WAS OBSERVED TO HAVE GRADE D ULCERATIVE ESOPHAGITIS AND DYSPHAGIA DUE TO STRICTURE. PT WAS DILATED AND SYMPTOMS WERE RESOLVED. PER THE PHYSICIAN THE SEVERITY OF THIS EVENT WAS MILD AND RELATIONSHIP OF THE EVENT TO THE DEVICE PROCEDURE WAS PROBABLE 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, INCORPORATED 90-9100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention