BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2121981 · Received June 3, 2011

    Report

    Report Number
    3004904811-2011-00016
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    December 21, 2010
    Report Date
    May 3, 2011
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A REPORT OF AN ADVERSE EVENT OCCURRING IN A PT ENROLLED IN THE US BARRETT'S RFA REGISTRY. THE PT IS A MALE WITH HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS. TWO MONTHS AFTER INITIAL FOCAL ABLATION, A MILD STRICTURE WAS NOTED AT THE GASTROESOPHAGEAL JUNCTION. DILATION WAS PERFORMED ONE TIME AND THE PHYSICIAN REPORTS THAT THE STRICTURE HAS RESOLVED. PER THE PHYSICIAN REPORT, THE ADVERSE EVENT SEVERITY WAS MILD, THE RELATIONSHIP 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 INC. 90-9100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention