BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY OPTIMA® URETERAL STENT

    MDR report key: 22483139 · Received July 11, 2025

    Report

    Report Number
    1018233-2025-05773
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    July 8, 2025
    Report Date
    February 24, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAD
    UDI-DI
    00801741015762
    PMA / PMN Number
    K043193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL FACILITY NAME: (B)(6). 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: SECTION 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED - CAUSE UNKNOWN. RECEIVED 1 URETERAL STENT. VERIFIED MATERIAL NUMBER 788626 AND BATCH NUMBER NGJR0224. VISUAL INSPECTION NOTED THE PIG TAIL WAS BROKEN OFF. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D,E,H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION 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 ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. WHEN THE PROCEDURE ENTERED THE CATHETERIZATION STAGE, THE URETERAL STENT WAS INSERTED. AFTER THE STENT WAS OPENED FROM ITS PACKAGE, THE STENT BROKE DURING INSERTION. THE SPECIFIC CAUSE OF THE BREAKAGE WAS UNKNOWN. THE UNIT HAD RICH CLINICAL OPERATION EXPERIENCE. THE CLINIC CHOSE TO OPEN A NEW PACKAGE, AND THE PRODUCT COMPLETED THE SUBSEQUENT OPERATIONS SMOOTHLY WITHOUT ANY PROBLEMS, AND THE OPERATION WAS COMPLETED SMOOTHLY. THE OPERATION WAS DELAYED, WITH NO OTHER IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY FOR KIDNEY STONES. WHEN THE PROCEDURE ENTERED THE CATHETERIZATION STAGE, THE URETERAL STENT WAS INSERTED. AFTER THE STENT WAS OPENED FROM ITS PACKAGE, THE STENT BROKE DURING INSERTION. THE SPECIFIC CAUSE OF THE BREAKAGE WAS UNKNOWN. THE UNIT HAD RICH CLINICAL OPERATION EXPERIENCE. THE CLINIC CHOSE TO OPEN A NEW PACKAGE, AND THE PRODUCT COMPLETED THE SUBSEQUENT OPERATIONS SMOOTHLY WITHOUT ANY PROBLEMS, AND THE OPERATION WAS COMPLETED SMOOTHLY. THE OPERATION WAS DELAYED, WITH NO OTHER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677755 BARD® INLAY OPTIMA® URETERAL STENT URETERAL STENT FAD C.R. BARD INC. (COVINGTON) -1018233 NGJR0224 00801741015762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other