BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1874288 · Received October 15, 2010

    Report

    Report Number
    3004904811-2010-00060
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BARRX MEDICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT REPORTED AS PART OF AN INTERNATIONAL TRIAL IN (B)(6) USING RFA FOR THE TREATMENT OF EARLY SQUAMOUS CELL NEOPLASIA OF THE ESOPHAGUS. THIS PATIENT WITH LOW-GRADE INTRAEPITHELIAL NEOPLASIA WAS TREATED WITH CIRCUMFERENTIAL ABLATION AND WAS NOTED TO HAVE SOME DYSPHAGIA IN THE MONTH AFTER TREATMENT. THEY WAS DILATED ONCE WITH IMPROVEMENT. ADDITIONAL INFORMATION AT THIS TIME IS NOT AVAILABLE REGARDING RESOLUTION OF SYMPTOMS OR STRICTURE. THE PHYSICIAN INDICATED THAT THE SEVERITY WAS SEVERE, RELATIONSHIP TO DEVICE UNKNOWN, AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INC. NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention