BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1340330 · Received March 4, 2009

    Report

    Report Number
    3004904811-2009-00010
    Event Type
    Other
    Date Received
    March 4, 2009
    Date of Event
    January 20, 2009
    Report Date
    February 9, 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

    A (B) (6) WITH 5 CM OF HGD TREATED WITH CIRCUMFERENTIAL RFA HAD A STRICTURE NOTED AT 3 MONTH FOLLOW-UP. DILATED SUCCESSFULLY. AWAITING BIOPSIES AND ADDITIONAL RFA.

    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 62 YR Required Intervention