BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1856651 · Received May 7, 2010

    Report

    Report Number
    3004904811-2010-00029
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    February 24, 2009
    Report Date
    March 12, 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

    THIS IS AN ADVERSE EVENT NOTED AS PART OF THE (B)(6). PT HAS INTRA-EPITHELIAL NEOPLASIA OF THE ESOPHAGUS. CIRCUMFERENTIAL ABLATION WAS PERFORMED WITHOUT ACUTE ADVERSE EVENT OR DEVICE MALFUNCTION. NAUSEA AND VOMITING WAS REPORTED 1-2 DAYS AFTER TREATMENT. A STRICTURE WAS NOTED ONE MONTH LATER AND WAS SERIALLY DILATED. THE STRICTURE AND SYMPTOMS WERE RELIEVED WITH DILATION. AT ONE YEAR ENDOSCOPY, THE STRICTURE WAS RESOLVED AND THE PT HAD NO DYSPHAGIA.

    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 56 YR Required Intervention