BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1856668 · Received May 7, 2010

    Report

    Report Number
    3004904811-2010-00031
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    May 28, 2009
    Report Date
    May 17, 2009
    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)(6). THIS IS A (B)(6) MALE WITH INTRA-EPITHELIAL NEOPLASIA OF THE ESOPHAGUS. CIRCUMFERENTIAL ABLATION WAS PERFORMED WITHOUT ACUTE ADVERSE EVENT REQUIRING INTERVENTION AND WITH NO DEVICE MALFUNCTION. AT THREE MONTH FOLLOW-UP, A STRICTURE WAS NOTED AS WELL AS AN AREA WHICH HAD NOT YET HEALED FROM TREATMENT. AT ONE YEAR ENDOSCOPY, THE STRICTURE WAS RESOLVED AND THE PT HAD NO DYSPHAGIA.

    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 54 YR Required Intervention