BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY® URETERAL STENT

    MDR report key: 23735154 · Received December 5, 2025

    Report

    Report Number
    1018233-2025-10865
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 28, 2025
    Report Date
    May 8, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAD
    UDI-DI
    00801741014833
    PMA / PMN Number
    K983498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARTIAL LEFT NEPHRECTOMY. TO PREVENT POSTOPERATIVE URINARY LEAKAGE, A DOUBLE-J STENT WAS PLACED IN THE URETER FOR INTERNAL DRAINAGE TO REDUCE RENAL PELVIC PRESSURE. A LEFT-SIDED DOUBLE-J STENT WAS INSERTED. AN F6 DOUBLE-J STENT WAS ATTEMPTED BUT ENCOUNTERED SIGNIFICANT DIFFICULTY DURING PLACEMENT OVER THE ZEBRA GUIDEWIRE. CONSIDERED FRICTION BETWEEN THE STENT LUMEN AND GUIDEWIRE, INITIALLY ATTRIBUTED TO INSUFFICIENT LUBRICATION. DESPITE ADEQUATE LUBRICATION, PLACEMENT REMAINED TIGHT, RAISING CONCERN FOR URETERAL STRICTURE. AN F5 URETERAL CATHETER WAS SUCCESSFULLY ADVANCED APPROXIMATELY 25 CM INTO THE URETER. SUBSEQUENTLY, AN F5 DOUBLE-J STENT WAS SELECTED AND SUCCESSFULLY PLACED OVER THE ZEBRA GUIDEWIRE TO THE TARGET LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493443 BARD® INLAY® URETERAL STENT URETERAL STENT FAD C.R. BARD INC. (COVINGTON) -1018233 NGKR0287 00801741014833

    Patients

    Seq Age Sex Outcome Treatment
    1