BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2050975 · Received April 1, 2011

    Report

    Report Number
    3004904811-2011-00008
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    October 28, 2010
    Report Date
    March 7, 2011
    Manufacturer
    BARRX MEDICAL, INC
    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 A REPORT OF AN ADVERSE EVENT IN A PT TREATED IN THE US RFA BARRETT'S REGISTRY FOR BARRETT'S ESOPHAGUS CONTAINING DYSPLASIA. AFTER AN INITIAL FOCAL ABLATION PROCEDURE, THE PT EXPERIENCE DIFFICULTY SWALLOWING ON OR ABOUT DAY 20. ENDOSCOPY SHOWED A MILD STRICTURE WHICH WAS DILATED ON TWO OCCASIONS TO COMPLETE RESOLUTION. PER THE STUDY SITE INVESTIGATOR, THE SEVERITY WAS MILD, RELATIONSHIP TO THE ABLATION 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, INC 90-9100 F1013182

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention