BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 1874291 · Received October 15, 2010

    Report

    Report Number
    3004904811-2010-00066
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    July 2, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BARRX MEDICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT REPORTED AS PART OF THE (B)(6) US PATIENT REGISTRY. PATIENT HAD A BARRETT'S ESOPHAGUS AND WAS TREATED WITH FOCAL ABLATION. A MILD STRICTURE WAS NOTED AFTER ABLATION WITH THE PATIENT REPORTING SOME DYSPHAGIA, YET ABLE TO SWALLOW SOFT FOOD AND LIQUIDS. THIS WAS DILATED SUCCESSFULLY IN ONE SESSION WITH ALLEVIATION OF SYMPTOMS. UPON THE NEXT ENDOSCOPY, THE STRICTURE HAD RESOLVED COMPLETELY. THE PHYSICIAN INDICATED THAT THE SEVERITY WAS MILD, RELATIONSHIP TO DEVICE DEFINITE, AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INC. 90-9100 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention