BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 2000868 · Received February 17, 2011

    Report

    Report Number
    1825146-2011-00014
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED, THE PT'S FAMILY HAS TAKEN THE PT TO A HOSP OTHER THAN THE REPORTING HOSPITAL FOR F/U ON THIS ISSUE. THE URETERAL STENT IS SUPPLIED WITH A RETRIEVING (STRING) TETHER, TO ASSIST IN KEEPING THE TETHER FROM TANGLING, A WHILE SEGMENT OF TUBING IS PLACED ON THE TIP OF THE LIGHT BLUE STENT TO HOLD THE TETHER IN PLACE DURING TRANSPORTATION. THE FACILITY HAS BEEN CONTACTED FOR ADD'L INFO AND AT THIS TIME HAVE NOT RECEIVED ANYTHING FURTHER. SHOULD INFO BE OBTAINED, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A PYELOPLASTY ON A CHILD ROBOTICALLY. THE 039518-R SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET 4.7 FR X 18CM WAS INSERTED LAPAROSCOPICALLY VIA THE ABDOMEN. OBVIOUSLY, THESE CASES ARE DONE IN THE DARK LAPAROSCOPICALLY SO IT WAS NOT NOTED THAT THERE WAS A 8MM SLEEVE OVER THE SUTURE END OF THE STENT. THE SLEEVE IS NOT LISTED IN THE INSTRUCTION SHEET AS BEING PRESENT IN THE "SET CONTAINS" SECTION, NOR DOES IT MENTION THAT THE PIECE SHOULD BE REMOVED PRIOR TO STENT INSERTION IN THE "SUGGESTED INSTRUCTION FOR USING" SECTION. THE STRINGS WERE CUT OFF THE STENT FOR THE ABDOMINAL APPROACH INSERTION BUT POSTOPERATIVELY IT WAS NOTED THAT THE PT HAD A FOREIGN BODY IN THE PELVIS WHICH WE BELIEVE IS THIS SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. NA UF1728536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention