BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 1854657 · Received October 1, 2010

    Report

    Report Number
    3004904811-2010-00054
    Event Type
    Other
    Date Received
    October 1, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL #: 3441C; LOT #: F1013082; EXPIRATION DATE: 12/31/2012. ADDITIONAL DEVICE MFR DATE: 01/2010.

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED IN THE (B)(6) REGISTRY. PT HAS VERY LONG SEGMENT (12 CM) BARRETT'S ESOPHAGUS WITH DYSPLASIA. AFTER CIRCUMFERENTIAL ABLATION, ON FOLLOW-UP ENDOSCOPY 2 MONTHS LATER, PT WAS NOTED TO HAVE A MILD TO MODERATE STRICTURE. THE PT DID NOT HAVE SYMPTOMS OF DYSPHAGIA. THE STRICTURE WAS DILATED A SINGLE TIME. THE NARROWING WAS DILATED TO FACILITATE INTRODUCTION OF THE FOCAL ABLATION DEVICE. PRESENTLY, THE PT HAS NO COMPLAINTS AND THE PHYSICIAN GRADED THE SEVERITY AS MILD-MODERATE, RELATIONSHIP TO PROCEDURE AS PROBABLE, AND NOT RELATED TO ANY DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED 32041-31 F1012805

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention