BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2121995 · Received June 3, 2011

    Report

    Report Number
    3004904811-2011-00019
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    November 4, 2010
    Report Date
    May 6, 2011
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A REPORT OF AN ADVERSE EVENT OCCURRING IN A PT ENROLLED IN THE US BARRETT'S RFA REGISTRY. THE PT IS A MALE WITH INDEFINITE FOR DYSPLASIA BARRETT'S ESOPHAGUS. THE PT HAD A PRIOR FUNDOPLICATION APPROX 10 YEARS PRIOR TO ENROLLMENT AND TREATMENT. APPROX 2 MONTHS AFTER A F/U FOCAL ABLATION, THE PT WAS NOTED TO HAVE A MILD STRICTURE, DILATED WITH A BALLOON DUE TO PT REPORTING MILD DIFFICULTY SWALLOWING MAINLY TO SOLID FOOD. TWO MONTHS LATER, ENDOSCOPY WAS REPEATED AND THE STRICTURE WAS GRADED AS MODERATE AND AGAIN DILATED. ONE MONTH LATER, ENDOSCOPY REPORTED AND STRICTURE WAS STATED TO BE MUCH IMPROVED (NOW MILD). THE PHYSICIAN REPORTS THAT THE STRICTURE IS MUCH IMPROVED BUT NOT YET RESOLVED. PER THE PHYSICIAN REPORT, THE ADVERSE EVENT SEVERITY WAS MODERATE, THE RELATIONSHIP TO THE DEVICE PROCEDURE WAS POSSIBLE, AND THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO90 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL INC. 90-9100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention