BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROVASIVE

    MDR report key: 279281 · Received May 24, 2000

    Report

    Report Number
    279281
    Event Type
    Other
    Date Received
    May 24, 2000
    Date of Event
    March 30, 2000
    Report Date
    May 23, 2000
    Manufacturer
    BOSTON SCIENTIFIC/MICROVASIVE D
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD UNDERGONE A RIGHT NEPHROSTOMY FOR OBSTRUCTION & FEVER FOLLOWED BY URETEROSCOPY FOR IMPACTED RIGHT URETERAL STONE RECENTLY. PT HAD AN INDWELLING STENT AND NEPHROSTOMY TUBE, BOTH TO BE REMOVED. UPON REMOVAL OF THE INDWELLING STENT, IT WAS NOTICED THAT PART OF THE UPPER COIL WAS MISSING AND LEFT IN THE KIDNEY. REPEATED ATTEMPTS WERE MADE TO RETRIEVE IT BUT ALL FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE 6 X 26 INDWELLING URETHRAL STENT FAD BOSTON SCIENTIFIC/MICROVASIVE D * 2751743

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other