BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LSE-SOF-FLEX PIGTAIL URETERAL STENT SET

    MDR report key: 3027812 · Received March 21, 2013

    Report

    Report Number
    1820334-2013-00129
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    COOK, UROLOGICAL, INC.
    Product Code
    FAD
    PMA / PMN Number
    K952513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REMOVAL OF DEVICE PORTIONS IS NOT LABELED IN THE IFU. DEVICE BREAKAGE IS NOT LABELED IN THE IFU. A STRAIGHT, 3 CM PIECE OF THE STENT WAS RETURNED. BOTH ENDS OF THE RETURNED PIECE SHOWED SIGNS OF SEPARATION AT SIDEPORTS. THE STENT MATERIAL WAS NOTED TO BE SLIGHTLY DISCOLORED. THE ROOT CAUSE OF THE FAILURE CANNOT BE PRECISELY DETERMINED BASED ON THE REPORT OR PHYSICAL EVIDENCE, HOWEVER, THE DEVICE WAS USED PAST ITS EXPIRATION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTION IS NECESSARY AT THIS TIME AS THERE IS INSUFFICIENT RISK DUE TO LOW SEVERITY AND HIGH DETECTABILITY.

    Description of Event or Problem · 1

    A (B)(6), MALE, UNDERWENT STENT PLACEMENT. THE EXPIRED LSE SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET WAS PLACED SUCCESSFULLY DURING THE INITIAL PROCEDURE. (B)(6) WEEKS LATER, THE PT COMPLAINED OF URINATING OUT PIECES OF THE STENT. X-RAYS WERE TAKEN, SHOWING PIECES OF THE STENT WERE IN THE URETER, KIDNEY, AND BLADDER OF PT. PORTIONS WERE EXTRACTED USING GRASPERS. ACCORDING TO THE INITIAL REPORTER, NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118814 LSE-SOF-FLEX PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK, UROLOGICAL, INC. NA UF1786289

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention