BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIS¿ URETERAL ACCESS SHEATH

    MDR report key: 23632789 · Received November 24, 2025

    Report

    Report Number
    1018233-2025-10500
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 14, 2025
    Report Date
    January 22, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    00801741101700
    PMA / PMN Number
    K160861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATE: "WARNINGS: THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. DIRECTIONS FOR USE: 1. INSPECT PRODUCT/PACKAGE FOR DAMAGE PRIOR TO USE. 2. ACTIVATE THE HYDROPHILIC COATING BY PLACING THE DILATOR AND SHEATH COMPONENTS INTO SALINE OR STERILE WATER. PLACE AN 0.035" (0.889 MM) OR 0.038" (0.965 MM) GUIDEWIRE INTO THE URETER USING STANDARD ENDOUROLOGY TECHNIQUES. 3. ENSURE THE DILATOR LOCK IS SECURELY ENGAGED WITH SHEATH HUB PRIOR TO INSERTION. 4. INSERT THE GUIDEWIRE INTO THE TAPERED END OF THE DILATOR/SHEATH ASSEMBLY AND GRADUALLY ADVANCE THE ASSEMBLY INTO THE URETER. PLACEMENT OF THE ASSEMBLY CAN BE VERIFIED USING FLUOROSCOPY OR RADIOGRAPHIC MEANS. 5. 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. SUTURE HOLES ARE PROVIDED ON SHEATH HUB FOR SECURING EXTERNALLY, IF DESIRED. 6. AN ENDOSCOPE AND/OR RELATED INSTRUMENTS CAN NOW BE USED THROUGH THE URETERAL SHEATH AS NEEDED. 7. 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. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: A,D,F,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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH ITEM # 231225 DURING SURGERY. THE ACCESS SHEATH BROKE IN HALF, AND THE SURGEON HAD TO RETRIEVE THE OF SHEATH. PER CUSTOMER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 21JAN2026, IT WAS REPORTED THAT THE PRODUCT WAS NO LONGER AVAILABLE TO BE RETURNED. THERE WAS NO PATIENT IMPACT, AND THE BROKEN ITEM WAS REMOVED IN ENTIRETY BY THE DOCTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH ITEM # 231225 DURING SURGERY. THE ACCESS SHEATH BROKE IN HALF, AND THE SURGEON HAD TO RETRIEVE THE OF SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323199 PROXIS¿ URETERAL ACCESS SHEATH URETERAL SHEATH FED C.R. BARD INC. (COVINGTON) -1018233 BMKTFM21 00801741101700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other