BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-SOF AQ DOUBLE PIGTAIL STENT SET

    MDR report key: 1884946 · Received October 21, 2010

    Report

    Report Number
    1825146-2010-00048
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. INITIAL INFO RECEIVED INDICATED THE DEVICE WAS NOT BEING USED AS INTENDED, BY PLACING THE POSITIONER INTO THE SCOPE AND THEN PLACING THE WIREGUIDE THROUGH. THE INTENDED USE FOR THE POSITIONER: PLACING THE WIRE GUIDE INTO THE PT FOLLOWED BY LOADING OF THE STENT ON THE WIRE AND MANEUVERING THE STENT INTO PLACE WITH THE POSITIONER NOTING THE POSITIONER WOULD BE INSERTED TO THE BLADDER ONCE THE STENT IS IN PLACE. FOR REMOVAL OF THE POSITIONER TIP, THE PT WAS PREVIOUSLY SCHEDULED TO RETURN FOR ANOTHER LITHOTRIPSY PROCEDURE DUE TO ADDITIONAL KIDNEY STONES AND STENT REMOVAL NOTING THE PHYSICIAN WILL REMOVE THE TIP FROM THE PT DURING THIS PROCEDURE. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, UPON RECEIPT OF THE DEVICE AND PREVIOUSLY REQUESTED INFO, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS BACKLOADING THE POSITIONER THROUGH THE SCOPE AND DISLODGED THE RADIOPAQUE TIP. IT FELL OFF IN THE PT'S RENAL PELVIS WHEN THE PHYSICIAN EITHER REPLACED THE WIRE GUIDE OR STENT. HE DOES NOT KNOW WHICH. HE IS AWARE THAT USAGE OF THE POSITIONER IN THIS WAY IS NOT INDICATED FOR USE. THE RADIOPAQUE TIP OF THE POSITIONER WILL BE REMOVED WHEN THE PT RETURNS FOR A SECOND PROCEDURE. THE RADIOPAQUE TIP OF THE POSITIONER WILL BE REMOVED WHEN THE PT RETURNS FOR A SECOND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO-SOF AQ DOUBLE PIGTAIL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention