BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRX

    MDR report key: 7839468 · Received August 31, 2018

    Report

    Report Number
    3004904811-2018-00024
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    June 9, 2015
    Report Date
    August 31, 2018
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE EFFECTIVENESS OF FOCAL VS. BALLOON RADIOFREQUENCY ABLATION DEVICES IN THE TREATMENT OF BARRETT¿S ESOPHAGUS. SOURCE UNITED EUROPEAN GASTROENTEROLOGY JOURNAL. (1 - 6), 2015. DATE OF PUBLICATION: 9 JUNE 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RETROSPECTIVE CROSS-SECTIONAL STUDY OF PATIENTS WHO UNDERWENT AT LEAST ONE TREATMENT WITH EITHER FOCAL AND/OR BALLOON RADIOFREQUENCY ABLATION (RFA) DEVICES. RFA WAS PERFORMED TO TREAT PATIENTS WITH HIGH-GRADE DYSPLASIA (HGD) AND INTRAMUCOSAL CANCER, AND LOW-GRADE DYSPLASIA (LGD). REPEATED ABLATIONS (EVERY TWO TO FOUR MONTHS IN PATIENTS WITH HGD/INTRAMUCOSAL CANCER OR EVERY SIX TO 12 MONTHS IN PATIENTS WITH LGD WERE PERFORMED TO TREAT RESIDUAL BARRETT¿S ESOPHAGUS (BE) AFTER ENDOSCOPIC MUCOSAL RESECTION (EMR) WAS PERFORMED TO TREAT CANCER. ONE PATIENT IN THE BALLOON RFA GROUP HAD ESOPHAGEAL STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680875 BARRX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP BARRX UNKNOWN HALO 360 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention