BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2439610 · Received January 12, 2012

    Report

    Report Number
    3004904811-2011-00073
    Event Type
    Other
    Date Received
    January 12, 2012
    Date of Event
    May 4, 2011
    Report Date
    December 20, 2011
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 1CM NON-DYSPLASTIC BARRETT'S ESOPHAGUS. AFTER A SECONDARY FOCAL ABLATION THE PT COMPLAINED OF DYSPHAGIA. PT WAS DILATED AND SYMPTOMS WERE RESOLVED. PER THE PHYSICIAN THE SEVERITY OF THIS EVENT WAS MODERATE AND RELATIONSHIP OF THE EVENT TO THE DEVICE PROCEDURE WAS UNK 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 66 YR Required Intervention