BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® INLAY® URETERAL STENT

    MDR report key: 21892828 · Received April 23, 2025

    Report

    Report Number
    1018233-2025-02947
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 13, 2025
    Report Date
    July 3, 2025
    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
    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 IS CONFIRMED CAUSE UNKNOWN DUE TO FAIR-03-0032. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. VISUAL EVALUATION NOTED RECEIVED 1 URETERAL STENT WITH PIGTAIL BROKEN OFF STENT. ALSO RECEIVED ONE PHOTO SAMPLE THAT SHOWS THE TOP VIEW OF DAMAGE PRESENT ON PIGTAIL OF STENT. A DHR REVIEW IS NOT REQUIRED, AS THE INFORMATION NEEDED TO INVESTIGATE THE ISSUE IS ALREADY DETERMINED WITHOUT REVIEWING THE DHR. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: PRECAUTIONS: 1. FOR SINGLE USE ONLY. DO NOT RESTERILIZE. DO NOT USE IF THE PACKAGE OR PRODUCT IS DAMAGED. 2. IMPROPER HANDLING TECHNIQUE CAN SERIOUSLY WEAKEN THE STENT. ACUTE BENDING OR OVERSTRESSING DURING PLACEMENT COULD RESULT IN SUBSEQUENT SEPARATION OF THE STENT AT THE POINT OF STRESS AFTER A PROLONGED. INDWELLING PERIOD. 3. SUTURE MAY BE CUT OFF PRIOR TO STENT PLACEMENT. REMOVE SUTURE PRIOR TO PLACEMENT FOR PEDIATRIC PATIENTS. 4. EXERCISE CARE. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. 5. URETERAL STENTS SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF ENCRUSTATION AND PROPER FUNCTION. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND/OR RADIOGRAPHIC PROCEDURES ARE RECOMMENDED AT INTERVALS DEEMED TO BE APPROPRIATE BY THE PHYSICIAN IN CONSIDERATION OF THE INDIVIDUAL PATIENT'S CONDITION AND OTHER PATIENT SPECIFIC FACTORS. WHEN LONG-TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 365 DAYS. THE STENT IS NOT INTENDED AS A PERMANENT INDWELLING DEVICE.* 6. CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT FROM INNER POLYBAG SO AS NOT TO CAUSE TEARING OR FRAGMENTATION. F AVOID IMPROPER HANDLING OF STENT SUCH AS BENDING, KINKING, TEARING, ETC. MISUSE COULD DAMAGE THE OVERALL INTEGRITY OF THE STENT. CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT FROM THE INNER POLYBAG TO ELIMINATE TEARING OR FRAGMENTATION. (2) AVOID IMPROPER HANDLING WHICH MAY AFFECT THE INTEGRITY OF THIS DEVICE, INCLUDING BENDING, KINKING, OR TEARING. (3) EXERCISE CAUTION TO AVOID DAMAGING THE STENT WITH SHARP INSTRUMENTS. THIS MAY CAUSE THIS DEVICE TO TEAR, BREAK, OR FRAGMENT. (8) CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT TO ELIMINATE TEARING OR FRAGMENTATION. (2) AVOID IMPROPER HANDLING WHICH MAY AFFECT THE INTEGRITY OF THIS DEVICE, INCLUDING BENDING, KINKING, OR TEARING. (3) EXERCISE CAUTION TO AVOID DAMAGING THE STENT WITH SHARP INSTRUMENTS. THIS MAY CAUSE THIS DEVICE TO TEAR, BREAK, OR FRAGMENT. (8) CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT TO ELIMINATE TEARING OR FRAGMENTATION. (2) AVOID IMPROPER HANDLING OF STENT SUCH AS BENDING, KINKING, TEARING, ETC. MISUSE COULD DAMAGE THE OVERALL INTEGRITY OF THE STENT. (3) AVOID CONTACT WITH SHARP EDGES AS THIS MAY CAUSE DAMAGE TO THE STENT. IF GRASPING DEVICE IS USED, THE STENT SHOULD BE REMOVED FROM URETER FIRST. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. (8) CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT TO ELIMINATE TEARING OR FRAGMENTATION. PRECAUTIONS: 1. FOR SINGLE USE ONLY. DO NOT RESTERILIZE. DO NOT USE IF THE PACKAGE OR PRODUCT IS DAMAGED. 2. IMPROPER HANDLING TECHNIQUE CAN SERIOUSLY WEAKEN THE STENT. ACUTE BENDING OR OVERSTRESSING DURING PLACEMENT COULD RESULT IN SUBSEQUENT SEPARATION OF THE STENT AT THE POINT OF STRESS AFTER A PROLONGED INDWELLING PERIOD. 3. REMOVE SUTURE PRIOR TO PLACEMENT FOR PEDIATRIC PATIENTS. 4. EXERCISE CARE. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS. 5. ALL STENTS WILL BE SUBJECTED TO VARYING DEGREES OF ENCRUSTATION WHEN PLACED IN THE URINARY TRACT. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND RADIOGRAPHIC MEANS ARE RECOMMENDED. WHEN ENCRUSTATION IS SEVERE ENOUGH TO POTENTIALLY OCCLUDE THE STENT, REPLACE IT WITH A NEW ONE. IT IS RECOMMENDED THAT A SINGLE STENT NOT REMAIN INDWELLING MORE THAN FOUR (4) WEEKS. THE STENT MAY BE REPLACED WITH A NEW STENT IF THE PATIENT'S STATUS PERMITS. 6. CARE SHOULD BE EXERCISED WHEN REMOVING THE STENT SO AS NOT TO CAUSE TEARING OR FRAGMENTATION. CORRECTION: D, 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 UNPACKED AND OPENED THE STENT AND FOUND THE HEAD END OF THE STENT WAS BROKEN AND UNUSABLE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23APR2025, STATED THAT THEY REPLACED THE BRACKET WITH A NEW ONE. THE BROKEN STENT WAS NOT USED, AND A NEW STENT HAD BEEN REPLACED FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNPACKED AND OPENED THE STENT AND FOUND THE HEAD END OF THE STENT WAS BROKEN AND UNUSABLE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23APR2025, STATED THAT THEY REPLACED THE BRACKET WITH A NEW ONE. THE BROKEN STENT WAS NOT USED, AND A NEW STENT HAD BEEN REPLACED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291110 BARD® INLAY® URETERAL STENT URETERAL STENT FAD C.R. BARD INC. (COVINGTON) -1018233 NGJS0325 00801741014833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other