BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRX

    MDR report key: 11627286 · Received April 7, 2021

    Report

    Report Number
    3004904811-2021-00006
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    November 1, 2015
    Report Date
    April 7, 2021
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    UDI-DI
    10884521211599
    PMA / PMN Number
    K142364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: RADIOFREQUENCY ABLATION FOR BARRETT¿S OESOPHAGUS RELATED NEOPLASIA WITH THE 360 EXPRESS CATHETER: INITIAL EXPERIENCE FROM THE UNITED KINGDOM AND IRELAND¿PRELIMINARY RESULTS SOURCE: SURGICAL ENDOSCOPY HTTPS://DOI.ORG/10.1007/S00464-021-08325-0 RECEIVED: 29 JUNE 2020 / ACCEPTED: 13 JANUARY 2021 © THE AUTHOR(S) 2021. 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 NOVEMBER 2015 TO NOVEMBER 2017, RADIO-FREQUENCY ABLATION (RFA) FOR BARRETT¿S OESOPHAGUS (BE)-RELATED NEOPLASIA WAS DONE TO PRESENT REAL WORLD DATA ON THE USE OF THE 360 EXPRESS CATHETER. THE AIM OF THIS STUDY WAS TO RETROSPECTIVELY EVALUATE THE EFFICACY AND SAFETY (IN TERMS OF STRICTURE FORMATION) OF THE 360 EXPRESS RFA BALLOON CATHETER. THERE WERE 123 PATIENTS AND 112 OF THEM HAD A FOLLOW UP ENDOSCOPY. THE MEDIAN AGE WAS 67 YEARS. OUT OF 112 PATIENTS, 5 PATIENTS (15%) DEVELOPED STRICTURES REQUIRING DILATION. THE PRIMARY OUTCOME WAS THE SURFACE REGRESSION OF BARRETT¿S OESOPHAGUS AT 3 MONTHS AS CALCULATED BY % CHANGE IN CIRCUMFERENTIAL. THE 5 PATIENTS DEVELOPED ESOPHAGEAL STRICTURES THAT WERE SYMPTOMATIC, AND WHICH REQUIRED ENDOSCOPIC DILATION. THE MEDIAN NUMBER OF DILATIONS REQUIRED TO RESOLVE WAS 2 AND ALTHOUGH 2 PATIENTS REQUIRED 5 DILATIONS, MOST WERE NOT REFRACTORY STRICTURES AND WERE THEREFORE AMENABLE TO ENDOSCOPIC BALLOON DILATATION TO ALLOW ALLEVIATION OF THE RESULTANT DYSPHAGIA. SECONDARY ANALYSIS WAS PERFORMED TO ASSESS IF STRICTURE FORMATION WAS RELATED TO THE TREATMENT REGIMEN USED. THE 12 J/CM2 ENERGY SETTING WAS ASSOCIATED WITH SIGNIFICANTLY MORE STRICTURES THAN THE 10 J/CM2. THE INSTRUCTION FOR USE (IFU) STATED THAT THE DOSIMETRY AND TREATMENT PROTOCOL FOR THE NEW DEVICE USED IN CLINICAL PRACTICE SHOULD BE 10 J/CM2 AND THAT A CLEANING PHASE A DISTAL ATTACHMENT CAP FOLLOWED BY WATER IRRIGATION SHOULD BE PERFORMED WHEN THE DEVICE IS USED FOR THE TREATMENT OF BARRETT¿S OESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527747 BARRX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP BARRX 64082 UNKNOWN 10884521211599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention