BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 1833085 · Received April 26, 2010

    Report

    Report Number
    3004904811-2010-00008
    Event Type
    Other
    Date Received
    April 26, 2010
    Date of Event
    December 8, 2006
    Report Date
    March 26, 2010
    Manufacturer
    BARRX MEDICAL, INC.
    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

    PATIENT WITH VERY LONG SEGMENT BARRETT'S AND HIGH-GRADE DYSPLASIA (14 CM) UNDERWENT ENDOSCOPIC MUCOSAL RESECTION FOR VISIBLE LESIONS WITHIN BARRETT'S SEGMENT. NO INFORMATION AVAILABLE ON WHETHER OR NOT THE PATIENT DEVELOPED DYSPHAGIA AFTER EMR OR IF THEY REQUIRED DILATION. THE PATIENT UNDERWENT ABLATION WITH THE FOCAL RFA DEVICE 3 MONTHS LATER, PERHAPS DUE TO NARROWING FROM EMR. A STRICTURE WAS NOTED AND DILATED. SUBSEQUENT ENDOSCOPY REPORTS STATE THAT THERE WAS EITHER NO STRICTURE OR A MILD STRICTURE, AND ABLATION CONTINUED UNTIL BARRETT'S RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention