BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO90 ABLATION CATHETER

    MDR report key: 2121977 · Received June 3, 2011

    Report

    Report Number
    3004904811-2011-00018
    Event Type
    Other
    Date Received
    June 3, 2011
    Date of Event
    March 5, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BARRX MEDICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS. THE PT HAD AN ENDOSCOPIC MUCOSAL RESECTION FOLLOWED THREE MONTHS LATER BY FOCAL ABLATION. FOUR DAYS AFTER FOCAL ABLATION, THE PT WAS ADMITTED FOR THREE DAYS TO THE HOSPITAL FOR COMPLAINTS OF DIFFICULT AND PAINFUL SWALLOWING. HE WAS PROVIDED WITH INTRAVENOUS FLUIDS AND PAIN CONTROL. A CONTRAST SWALLOWING STUDY WAS PERFORMED AND WAS NORMAL. APPROX THREE WEEKS AFTER DISCHARGE FROM THE HOSPITAL, THE PT UNDERWENT ENDOSCOPY WHICH SHOWED SOME PERSISTENT ULCERATION OF THE ABLATION ZONE CONSISTENT WITH PRIOR ABLATION (AND EXPECTED 1 MONTH AFTER ABLATION). THE PHYSICIAN REPORTED THAT THE ADVERSE EVENT WAS RESOLVED AFTER PERFORMING THE ENDOSCOPY. PER THE PHYSICIAN REPORT, THE ADVERSE EVENT SEVERITY WAS SEVERE, THE RELATIONSHIP TO THE DEVICE PROCEDURE WAS DEFINITE, 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 F1013305

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization