BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARRX

    MDR report key: 12181065 · Received July 16, 2021

    Report

    Report Number
    3004904811-2021-00011
    Event Type
    Death
    Date Received
    July 16, 2021
    Report Date
    July 16, 2021
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    UDI-DI
    10884521189379
    PMA / PMN Number
    K120431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PHYSICIAN USED AN ULTRA 90 CATHETER TO TREAT A 1 CM SEGMENT OF LOW DYSPLASIA. THE PATIENT WAS ON EFFIENT (BLOOD THINNER) BUT IT WAS HELD 7 DAYS PRIOR TO PROCEDURE. THE ABLATIONS WERE PERFORMED WITH 1 TAP ¿ CLEAN ¿ 1 TAP PROTOCOL GIVEN THEY USED THE ULTRA. THE PROCEDURE WAS VERY SHORT AND EXTREMELY UNEVENTFUL, NO SYMPTOMS AFTERWARDS. THERE WAS NOT EVEN ANY SIGNIFICANT OOZING AFTER RFA (RADIOFREQUENCY ABLATION) PERFORMED. THERE WAS NO EVIDENCE OF LIVER DISEASE, AND NO VARICES ON EXAM. THE PATIENT WAS DISCHARGED HOME ON THE TYPICAL REGIMEN OF SUCRALFATE, BID PPI (TWICE A DAY, PROTON PUMP INHIBITORS) AND VISCOUS LIDOCAINE AS PER OUR UNIT PROTOCOL FOLLOWING RFA. THE PATIENT WAS ASYMPTOMATIC UNTIL 10 DAYS AFTER THE RFA, WHEN THE PATIENT DEVELOPED ACUTE ONSET HEMATEMESIS (VOMITING OF BLOOD). THE PATIENT HAD TO RESUME EFFIENT AROUND A WEEK AFTER THE PROCEDURE DUE TO CARDIAC COMORBIDITIES. THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL FOR THE GASTROINTESTINAL BLEED AND INITIAL EGD SHOWED PRESENCE OF LARGE AMOUNT OF BLOOD IN THE ESOPHAGUS, BUT NOTHING ACTIVELY BLEEDING. THE PATIENT WAS EMBOLIZED BY IR (INTERVENTIONAL RADIOLOGY) AND FOLLOW UP EGD SHOWED ULCERS AT THE DISTAL ESOPHAGUS WITHOUT ANY STIGMATA AND NO BLEEDING. IT WAS CONFIRMED THAT THERE WAS NO SIGNIFICANT OVERLAP BETWEEN ABLATION HIT LOCATIONS AND THE ENERGY DENSITY USED WAS 12 FOR THE ULTRA, THEY LEFT THE SETTING AT THE DEFAULT. IT WAS LEARNED THAT THE PATIENT DIED 10 DAYS AFTER THE PROCEDURE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080887 BARRX ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN LP BARRX 90-9200 10884521189379

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R