BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT UL2 ATC IMPLANT CARTRIDGE

    MDR report key: 23594425 · Received November 19, 2025

    Report

    Report Number
    3015181082-2025-00060
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 21, 2025
    Report Date
    October 21, 2025
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020459
    PMA / PMN Number
    K232558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED " NOTICED THROUGHOUT THE PROCEDURE CARTRIDGES WERE SLIGHTLY MORE DIFFICULT TO INSERT BUT STILL SEEMED TO BE LOCKING IN PROPERLY. BEFORE PLACING THE 6TH IMPLANT, THE DELIVERY SYSTEM NEEDED TO BE RESET. IT SEEMED LIKE THE TRIGGER HADN'T BEEN FULLY RETRACTED AFTER LAST IMPLANT DELIVERY. PHYSICIAN SUCCESSFULLY INSERTED ATC CARTRIDGE INTO DELIVERY SYSTEM AND ATTEMPTED PLACEMENT ON PATIENTS LEFT PROXIMAL SLIGHTLY ANTERIOR TO FIRST PROXIMAL IMPLANT. AFTER RETRACTING NEEDLE/3RD PULL THE KEYHOLE SHOWED METAL THAT LOOKED LIKE THE NEEDLE, NOT A CT OR UE. SUCCESSFULLY REMOVED DELIVERY SYSTEM BUT THE TIP OF DELIVERY SYSTEM SHOWED THE NEEDLE WAS BROKEN IN HALF. WE USED VO TO LOOK INSIDE PATIENT AND SAW NEEDLE TIP FLOATING AT THE BASE OF THE BLADDER. PHYSICIAN USED A GRASPER TO REMOVE TIP OF NEEDLE THROUGH RIGID CYSTO SHEATH. PATIENT HAD SOME IRRITATION TO THE BLADDER WALL FROM NEEDLE WHICH RESULTED IN PLACEMENT OF A CATHETER. PATIENT HAD CATHETER REMOVED NEXT DAY AND DOES NOT REPORT ANY ADDITIONAL CONCERNS".

    Description of Event or Problem · 0

    IT WAS REPORTED " NOTICED THROUGHOUT THE PROCEDURE CARTRIDGES WERE SLIGHTLY MORE DIFFICULT TO INSERT BUT STILL SEEMED TO BE LOCKING IN PROPERLY. BEFORE PLACING THE 6TH IMPLANT, THE DELIVERY SYSTEM NEEDED TO BE RESET. IT SEEMED LIKE THE TRIGGER HADN'T BEEN FULLY RETRACTED AFTER LAST IMPLANT DELIVERY. PHYSICIAN SUCCESSFULLY INSERTED ATC CARTRIDGE INTO DELIVERY SYSTEM AND ATTEMPTED PLACEMENT ON PATIENTS LEFT PROXIMAL SLIGHTLY ANTERIOR TO FIRST PROXIMAL IMLANT. AFTER RETRACTING NEEDLE/3RD PULL THE KEY HOLE SHOWED METAL THAT LOOKED LIKE THE NEEDLE, NOT A CT OR UE. SUCCESSFULLY REMOVED DELIVERY SYSTEM BUT THE TIP OF DELIVERY SYSTEM SHOWED THE NEEDLE WAS BROKEN IN HALF. WE USED VO TO LOOK INSIDE PATIENT AND SAW NEEDLE TIP FLOATING AT THE BASE OF THE BLADDER. PHYSICIAN USED A GRASPER TO REMOVE TIP OF NEEDLE THROUGH RIGID CYSTO SHEATH. PATIENT HAD SOME IRRITIATION TO THE BLADDER WALL FROM NEEDLE WHICH RESULTED IN PLA CEMENT OF A CATHETER. PATIENT HAD CATHETER REMOVED NEXT DAY AND DOES NOT REPORT ANY ADDITIONAL CONCERNS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326520 UROLIFT UL2 ATC IMPLANT CARTRIDGE IMPLANTABLE TRANSPROSTATIC TIS PEW NEOTRACT, INC. 73G2500079 10814932020459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.