BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ULTRA ABLATION CATHETER

    MDR report key: 1854652 · Received October 1, 2010

    Report

    Report Number
    3004904811-2010-00057
    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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT OCCURRING IN A PT WITH SEVERE GERD TREATED PREVIOUSLY WITH FUNDOPLICATION. THEY HAD BARRETT'S ESOPHAGUS WITH HIGH-GRADE DYSPLASIA THAT WAS THEN TREATED WITH FOCAL ABLATION. SINCE THEY HAD PRIOR FUNDOPLICATION, NO ANTI-SECRETORY MEDICATION WAS USED AFTER ABLATION. THE PT DEVELOPED DIFFICULTY SWALLOWING AND WAS NOTED TO HAVE A STRICTURE. HE WAS DILATED AND REPORTED RESOLUTION OF HIS SYMPTOMS. PHYSICIAN ATTRIBUTES STRICTURE TO THE FAILURE FOR THE PT TO ADMINISTER ANTI-SECRETORY THERAPY AFTER ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ULTRA ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED 90-9200 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention