BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRX

    MDR report key: 7831967 · Received August 30, 2018

    Report

    Report Number
    3004904811-2018-00021
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    February 26, 2018
    Report Date
    August 30, 2018
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE A SINGLE-STEP SIZING AND RADIOFREQUENCY ABLATION CATHETER FOR CIRCUMFERENTIAL ABLATION OF BARRETT¿S ESOPHAGUS: RESULTS OF A PILOT STUDY SOURCE UNITED EUROPEAN GASTROENTEROLOGY JOURNAL 0(0) 1¿10 2018 (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATES THAT, UNCONTROLLED, PROSPECTIVE MULTICENTER PILOT STUDY. THIRTY (30) BARRETT¿S ESOPHAGUS (BE) PATIENTS IN STUDY. BE PATIENTS WITH LOW-GRADE DYSPLASIA (LGD), HIGH-GRADE DYSPLASIA (HGD) OR EARLY CANCER (EC) WERE INCLUDED. VISIBLE LESIONS WERE REMOVED BY ENDOSCOPIC RESECTION (ER) PRIOR TO RADIOFREQUENCY ABLATION (RFA). RFA WAS PERFORMED WITH THE 360 EXPRESS USING THE STANDARD ABLATION REGIMEN. CIRCUMFERENTIAL ABLATION WAS PERFORMED USING THE BARRX 360 EXPRESS RFA BALLOON CATHETER. ADDITIONAL FOCAL RFA SESSIONS USING THE STANDARD ABLATION WERE SCHEDULED APPROXIMATELY EVERY THREE MONTHS UNTIL COMPLETE ENDOSCOPIC ERADICATION OF ALL BE WAS ACHIEVED. AFTER COMPLETE ENDOSCOPIC AND HISTOLOGICAL ERADICATION OF INTESTINAL METAPLASIA AND DYSPLASIA. ALL STUDY PATIENTS RECEIVED ESOMEPRAZOLE 40 MG TWICE A DAY (OR AN EQUIVALENT DOSE OF PROTON PUMP INHIBITOR) AS A MAINTENANCE DOSAGE DURING THE STUDY. IN ADDITION, PATIENTS WERE PRESCRIBED RANITIDINE 300 MG AT BEDTIME AND 5 ML SUCRALFATE SUSPENSION FOR A PERIOD OF TWO WEEKS FOLLOWING RFA. ONE PATIENT EXPERIENCED MUCOSAL LACERATION. ONE PATIENT EXPERIENCED ASYMPTOMATIC ATRIAL FIBRILLATION. ONE PATIENT EXPERIENCED VOMITING AND DYSPHAGIA. ONE PATIENT EXPERIENCED DYSREGULATED DIABETES. THREE PATIENTS HAD PRONOUNCED ESOPHAGEAL SCARRING AT THE THREE-MONTH FOLLOW-UP ENDOSCOPY. IN THREE OF THE SEVEN PATIENTS, ENDOSCOPIC RESECTION (ER) WAS PERFORMED PRIOR TO RFA TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674737 BARRX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP BARRX 64082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other