BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 1817583 · Received April 14, 2010

    Report

    Report Number
    3004904811-2010-00007
    Event Type
    Other
    Date Received
    April 14, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 12, 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

    A PT WITH BARRETT'S ESOPHAGUS UNDERWENT FOCAL RFA AS A PART OF THE (B)(6) REGISTRY AND WAS FOUND TO HAVE A STRICTURE ONE MONTH LATER. THIS WAS DILATED TO RESOLUTION ONE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention