BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 1180839 · Received September 23, 2008

    Report

    Report Number
    3005099803-2008-04766
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLONOSCOPY PROCEDURE, THE ROTATABLE SNARE BECAME TANGLED. THE PHYSICIAN HAD SNARED A POLYP IN THE LEFT COLON AND THE NURSE ATTEMPTED TO CLOSE THE SNARE. THE SNARE BECAME TANGLED. IT WAS REPORTED THAT THERE APPEARED TO BE A KNOT IN THE SNARE AND IT WAS NOT POSSIBLE TO CLOSE THE SNARE. THE SCOPE WAS REMOVED AND THE CATHETER WAS CUT TO REMOVE THE SNARE. IT WAS NOT POSSIBLE TO REMOVE THE SNARE THROUGH THE WORKING CHANNEL DUE TO THE KNOT. THERE WERE NO PT COMPLICATIONS AND THE PT WAS REPORTED TO BE STABLE POST PROCEDURE. THE PROCEDURE WAS REPORTED TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE SNARE FDI - FLEXIBLE ROTATION SNARE FDI BOSTON SCIENTIFIC CORPORATION M00561831 11816907

    Patients

    Seq Age Sex Outcome Treatment
    1