BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 20334071 · Received September 30, 2024

    Report

    Report Number
    1820334-2024-01283
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 8, 2024
    Report Date
    September 22, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002148987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: PMA/510(K) NUMBER = K180053. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' WAS PLACED ON (B)(6) 2024 FOR TREATMENT OF A PELVIC TUMOR AND HYDRONEPHROSIS. THE PATIENT WAS DISCHARGED HOME BUT RETURNED ON (B)(6) 2024 DUE TO THE STENT PROTRUDING FROM URETHRAL MEATUS. THE PATIENT RETURNED TO THE OPERATING ROOM WHERE IT WAS NOTED THAT THE DEVICE HAD SEPARATED; THE SURGEON USED A URETEROSCOPE TO CHECK FOR ANY REMAINING STENT FRAGMENTS IN THE URETHRA AND KIDNEY. IT WAS REPORTED THAT THE REMAINING PIECES OF THE STENT WERE REMOVED. A REPLACEMENT STENT WAS PLACED AND THE PATIENT WAS HOSPITALIZED FOR AN ADDITIONAL DAY. THE DEVICE DID NOT PERFORATE ANY PART OF THE PATIENT'S ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061247 SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G14898 14951501 00827002148987

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Female Required Intervention