BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3004904811-2020-00004

    MDR report key: 9876131 · Received March 24, 2020

    Report

    Report Number
    3004904811-2020-00004
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    December 3, 2017
    Report Date
    March 24, 2020
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ARTICLE: MASSIMILIANO DI PIETRO, UNITED EUROPEAN GASTROENTEROLOGY JOURNAL 2018, VOL. 6(5) 662¿668. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED 2007 AND 2017, NINE PATIENTS REQUIRED RESCUE EMR (ENDOSCOPIC MUCOSAL RESECTION) DUE TO DEVELOPMENT OF NEW NODULAR LESIONS AFTER COMMENCING THE RFA (RADIOFREQUENCY ABLATION). 10 PATIENTS DEVELOPED STRICTURE FOLLOWING RFA (RADIOFREQUENCY ABLATION) AND THEY REQUIRED DILATION. ONE PATIENT IN THE HGD (HIGH-GRADE DYSPLASIA) GROUP DEVELOPED ATRIAL FIBRILLATION DURING ABLATION NECESSITATING CESSATION OF THE RFA (RADIOFREQUENCY ABLATION). AFTER A BRIEF PAUSE, THE ABLATION WAS RESUMED AND THE PROCEDURE WAS COMPLETED. ONE PATIENT DEVELOPED DELAYED SYMPTOMATIC ATRIAL FIBRILLATION 36 HOURS AFTER TWO CONSECUTIVE ABLATIONS WHICH REQUIRED HOSPITAL ADMISSION AND PHARMACOLOGICAL CARDIOVERSION. ONE PATIENT REQUIRED ADMISSION POST PROCEDURE BECAUSE OF SEVERE CHEST PAIN AND TOTAL DYSPHAGIA. NO STRICTURE WAS NOTED FOR THIS PATIENT DURING ENDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334451 GEI COVIDIEN LP BARRX UNK-BARRX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R