BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9174385 · Received October 10, 2019

    Report

    Report Number
    1717344-2019-01306
    Event Type
    Death
    Date Received
    October 10, 2019
    Report Date
    October 10, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: FEASIBILITY AND OUTCOMES OF PERCUTANEOUS THERMAL ABLATION OF HEPATOCELLULAR CARCINOMA IN A TRANSPLANTED ALLOGRAFT SOURCE: BRIAN T. WELCH, 2017, ABDOMINAL RADIOLOGY, (2018) 43:1478¿1481, 21 SEPTEMBER 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI10 ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED ON JANUARY 2000 TO SEPTEMBER 2016, ONE PATIENT (8%) EXPERIENCED A MAJOR COMPLICATION. THIS PATIENT DEVELOPED A HEPATIC ABSCESS FOUR WEEKS AFTER THE ABLATION PROCEDURE FOR RECURRENT HCC. THE PATIENT HAD ROUX-EN-Y BILIARY RECONSTRUCTION AT THE TIME OF LT AND FOR UNCLEAR REASONS DID NOT RECEIVE POST-PROCEDURE ANTIBIOTICS AFTER ABLATION. CT IMAGES DEMONSTRATED RESIDUAL VIABLE TUMOR AND CONCOMITANT ABSCESS IN THE ABLATION BED. THE PATIENT WAS TREATED WITH RIGHT HEPATECTOMY. HE SUBSEQUENTLY DEVELOPED HCC RECURRENCE ALONG THE HEPATECTOMY MARGIN AND DIED 17 MONTHS AFTER ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970650 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R