BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIS¿ URETERAL ACCESS SHEATH

    MDR report key: 20135649 · Received September 4, 2024

    Report

    Report Number
    1018233-2024-05491
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 17, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FED
    UDI-DI
    00801741101694
    PMA / PMN Number
    K160861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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: 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 INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE ¿EQUIPMENT ERROR". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿INDICATIONS FOR USE: THE PROXIS¿ URETERAL ACCESS SHEATH IS INDICATED FOR USE IN ENDOSCOPIC UROLOGY PROCEDURES WHERE URETERAL DILATION AND URETERAL ACCESS IS DESIRED FOR INJECTION OF FLUIDS AND INSERTION AND REMOVAL OF ENDOSCOPES AND RELATED INSTRUMENTS 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. DO NOT USE IF STERILE BARRIER IS DAMAGED. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND WITH APPLICABLE LAWS AND REGULATIONS. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. PRECAUTIONS: THE RECOMMENDATIONS GIVEN ARE MEANT TO SERVE ONLY AS A BASIC GUIDE TO THE UTILIZATION OF THIS ACCESS SHEATH. THE URETERAL ACCESS SHEATH SHOULD NOT BE USED WITHOUT COMPREHENSIVE KNOWLEDGE OF THE INDICATIONS, TECHNIQUES AND RISKS OF THE PROCEDURE. TO MINIMIZE RESISTANCE DURING ADVANCEMENT, ENSURE THE HYDROPHILIC COATING ON THE DILATOR AND SHEATH IS ACTIVATED WITH SALINE OR STERILE WATER PRIOR TO PLACEMENT. DO NOT ADVANCE SHEATH WITHOUT THE DILATOR IN PLACE AS THIS COULD LEAD TO TRAUMA OR INJURY TO PATIENT. DO NOT BEND THE DEVICE PRIOR TO PLACEMENT AS THIS COULD DAMAGE THE INTEGRITY OF THE DEVICE AND RESULT IN PATIENT INJURY. DO NOT ADVANCE OR WITHDRAW DEVICE IF ANY RESISTANCE IS ENCOUNTERED DURING PLACEMENT OR REMOVAL WITHOUT DETERMINING CAUSE AND TAKING ACTION. ADVERSE EVENTS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE TRANSURETHRAL ACCESS DEVICE INCLUDE, BUT ARE NOT LIMITED TO: MUCOSAL IRRITATION, INFLAMMATION AND EDEMA URETHRAL STRICTURES ACUTE BLEEDING OR HEMORRHAGE URETHRAL, BLADDER, OR URETERAL PERFORATION OTHER INJURY TO THE URINARY TRACT.¿ 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

    THERE WERE A LOT OF CASES WHERE THE GUIDEWIRE WOULD NOT GO THROUGH BECAUSE THERE WAS SOMETHING LIKE GLUE REMAINING ON THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR. IN MANY CASES, IT WOULD GO THROUGH IF PRESSED IT HARD AND REPEATEDLY, AND MEDICON CLAIMS THAT THIS WAS A DEFECT. LOT#BMJRFM14 AND LOT#UNK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE A LOT OF CASES WHERE THE GUIDEWIRE WOULD NOT GO THROUGH BECAUSE THERE WAS SOMETHING LIKE GLUE REMAINING ON THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR. IN MANY CASES, IT WOULD GO THROUGH IF PRESSED IT HARD AND REPEATEDLY, AND MEDICON CLAIMS THAT THIS WAS A DEFECT. LOT#BMJRFM14 AND LOT#UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064353 PROXIS¿ URETERAL ACCESS SHEATH URETERAL ACCESS SHEATH FED C.R. BARD INC. (COVINGTON) -1018233 BMJRFM14 00801741101694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other