BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 1631199 · Received March 11, 2010

    Report

    Report Number
    3004904811-2010-00005
    Event Type
    Other
    Date Received
    March 11, 2010
    Date of Event
    April 20, 2007
    Report Date
    February 12, 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

    A (B) (6), PATIENT, WITH BARRETT'S ESOPHAGUS CONTAINING INTRAMUCOSAL CARCINOMA UNDERWENT ENDOSCOPIC RESECTION FOLLOWED BY ARGON PLASMA COAGULATION IN 2005 AND 2006. IT IS UNKNOWN IF THERE WAS NARROWING OR STENOSIS AFTER THIS INITIAL TREATMENT. IN 2007 THE PATIENT UNDERWENT FOCAL RFA DUE TO RESIDUAL BARRETT'S DISEASE AND DEVELOPED A STRICTURE AFTERWARDS, WHICH WAS SUCCESSFULLY DILATED TWO TIMES. SUBSEQUENT BIOPSIES IN 2007 AND 2008 SHOWED NO CANCER AND NO RESIDUAL BARRETT'S TISSUE. THE STRICTURE IS 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 61 YR Required Intervention