BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIS¿ URETERAL ACCESS SHEATH

    MDR report key: 23559744 · Received November 14, 2025

    Report

    Report Number
    1018233-2025-10329
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    May 14, 2025
    Report Date
    April 27, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    30382902310458
    PMA / PMN Number
    K160861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATE: DO NOT USE IF STERILE BARRIER IS DAMAGED. WARNING: FOR SINGLE USE ONLY. DO NOT REUSE, REPROCESS OR RESTERILIZE. REUSE, REPROCESSING OR RESTERILIZATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE AND/ OR LEAD TO DEVICE FAILURE, WHICH IN TURN, MAY RESULT IN PATIENT INJURY, ILLNESS OR DEATH. REUSE REPROCESSING OR RE-STERILIZATION MAY ALSO CREATE A RISK OF CONTAMINATION OF THE DEVICE AND/OR CAUSE PATIENT INFECTION OR CROSS INFECTION, INCLUDING, BUT NOT LIMITED TO, THE TRANSMISSION OF INFECTIOUS DISEASE(S) FROM ONE PATIENT TO ANOTHER. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. DIRECTIONS FOR USE: 1. ACTIVATE THE HYDROPHILIC COATING BY PLACING THE DILATOR AND SHEATH COMPONENTS INTO SALINE OR STERILE WATER. PLACE AN 0.035" (0.889MM) OR 0.038" (0.965MM) GUIDEWIRE INTO THE URETER USING STANDARD ENDOUROLOGY TECHNIQUES. 2. ENSURE THE DILATOR LOCK IS SECURELY ENGAGED WITH SHEATH HUB PRIOR TO INSERTION. 3. INSERT THE GUIDEWIRE INTO THE TAPERED END OF THE DILATOR/SHEATH ASSEMBLY AND GRADUALLY ADVANCE THE ASSEMBLY INTO THE URETER. NOTE: PLACEMENT OF THE ASSEMBLY CAN BE VERIFIED USING FLUOROSCOPY OR RADIOGRAPHIC MEANS. 4. WHILE MAINTAINING SHEATH POSITION, DISENGAGE THE DILATOR LOCK FROM THE SHEATH HUB TO GENTLY REMOVE THE DILATOR. DO NOT ADVANCE SHEATH WITHOUT THE DILATOR IN PLACE. NOTE: SUTURE HOLES ARE PROVIDED ON SHEATH HUB FOR SECURING EXTERNALLY, IF DESIRED. 5. AN ENDOSCOPE AND/OR RELATED INSTRUMENTS CAN NOW BE USED THROUGH THE URETERAL SHEATH AS NEEDED. 6. IF DESIRED, IRRIGATION CAN BE APPLIED USING THE LUER CONNECTOR ON THE DILATOR. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTIONS: D, H. 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.

    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 ON (B)(6) 2025, DURING A FLEXIBLE URETER LITHOTRIPSY, A DEFECT WAS REPORTED IN (B)(6). ACCESS SHEATH APPARENTLY CLOGGED, GUIDE WIRE NOT PASSING THROUGH. THE PRODUCT WAS STORED AND CLEANED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, DURING A FLEXIBLE URETER LITHOTRIPSY, A DEFECT WAS REPORTED IN 231045. ACCESS SHEATH APPARENTLY CLOGGED, GUIDE WIRE NOT PASSING THROUGH. THE PRODUCT WAS STORED AND CLEANED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228313 PROXIS¿ URETERAL ACCESS SHEATH URETERAL SHEATH FED C.R. BARD INC. (COVINGTON) -1018233 BMJRFM20 30382902310458

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Unknown Other