BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1856673 · Received May 7, 2010

    Report

    Report Number
    3004904811-2010-00012
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    February 27, 2010
    Report Date
    March 26, 2010
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT NOTED AS PART OF THE B-300 EARLY (B)(6) TRIAL IN (B)(6). THIS IS A (B)(6) MALE WITH HIGH-GRADE INTRA-EPITHELIAL NEOPLASIA (HGIN) OF THE ESOPHAGUS. CIRCUMFERENTIAL ABLATION WAS PERFORMED WITHOUT ACUTE ADVERSE EVENT OR DEVICE MALFUNCTION. DYSPHAGIA DEVELOPED WITHIN TWO WEEKS OF PROCEDURE AND A STRICTURE WAS NOTED ONE MONTH LATER AND WAS SERIALLY DILATED. SYMPTOMS SIGNIFICANTLY IMPROVED AFTER DILATION AND PT IS STILL BEING FOLLOWED TO DETERMINE IF ADDITIONAL DILATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention