BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOSEAL CS-17-QL-PFO

    MDR report key: 484311 · Received September 16, 2003

    Report

    Report Number
    1222632-2003-00016
    Event Type
    Other
    Date Received
    September 16, 2003
    Date of Event
    August 14, 2003
    Report Date
    September 15, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN OFF LABEL PROCEDURE TO CLOSE A FENESTRATED "FONTAN," THERE WAS A POWER FAILURE IN THE CATH LAB. DEVICE INADVERTENTLY RELEASED IN THE LA AND WAS WITHDRAWN WITH A SNARE THROUGH A 14F SHEATH INTRODUCED VIA TRANSHEPATIC ACCESS. PATIENT DEVELOPED BLEEDING AROUND AND OUTSIDE THE LIVER. BLEEDING WAS REPORTEDLY DUE TO THE INTRODUCTION OF THE LARGE 14F SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-17-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-17-QL-PFO 0207197

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization