BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT UL400 DELIVERY DEVICE & IMPLANT

    MDR report key: 22608588 · Received July 25, 2025

    Report

    Report Number
    3015181082-2025-00024
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 22, 2025
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020087
    PMA / PMN Number
    K193269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED, AND THE FOLLOWING OBSERVATIONS WERE MADE: RECEIVED WITHOUT TRAY, PUSHER D EPLOYED, CUTTER DEPLOYED, NEEDLE TRIGGER RETRACTED, RETRACT LEVER FULLY RETRACTED, LEVER LOCK AND TAPE DISENGAGED, URETHRAL ENDPIECE (UE) DEPLOYED, DISTAL TIP UNDAMAGED, UNSHEATHING PAWL NOT ENGAGED WITH SUTURE SPOOL, SUTURE UNBUCKLED, SHUTTLE NOT ENGAGED WITH NEEDLE SPOOL, SUTURE FERRULE IN PLACE, CASE RIGHT UNDAMAGED THE ITEMS LISTED ABOVE ARE INDICATORS OF DEVICE STATUS AND ARE AS EXPECTED FOR A DEVICE THAT FUNCTIONED AS DESIGNED. THE FOLLOW-ING DISCREPANCIES WERE OBSERVED:THE CT WAS PRESENT, UNSHEATHED, AND PULLED BACK INTO THE DISTAL TIP (CT PULL THROUGH), NEEDLE DAMAGED: THE NEEDLE IS BROKEN AT THE TIP. THE NEEDLE WAS FOUND TO BE BROKEN APPROXIMATELY 1 MM FROM THE TIP. COMPARISON WITH A REFERENCE NEEDLE SHOWS APPROXIMATELY 1 MM OF NEEDLE MISSING. THE MISSING NEEDLE MATERIAL WAS NOT RETURNED WITH THE DEVICE. DEVICE HIS-TORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER REPORT OF: " IMPLANT WAS NOT DELIVERED " WAS CONFIRMED. CONFIRMATION IS BASED ON THE INVESTIGATION RESULTS SHOWING THAT DEVICE SUFFERED A CT PULL THROUGH. THIS IS A KNOWN POSSIBLE OUTCOME OF THE PROCEDURE THUS THIS IS NOT CONSIDERED A MALFUNCTION. THIS INVESTIGATION HAS DETER-MINED THAT DEVICE ENCOUNTERED THE FOLLOWING FAILURE MODE(S):UL-CT PULL THROUGH: THE CT WAS PRESENT, UNSHEATHED, AND PULLED BACK INTO THE DISTAL TIP OF THE DEVICE. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERROR- UNINTENTIONAL CANNOT DETERMINE. UL-NEEDLE DAMAGED: NEEDLE DAMAGE OCCURS WHEN THE NEEDLE STRIKES BONE. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERROR- UNINTEN-TIONAL- CANNOT DETERMINE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DESCRIPTION OF THE INCIDENT: THIS INTRAPROSTATIC IMPLANT WAS NOT DELIVERED BY UROLIFT DEVICE. ANOTHER IMPLANT WAS USED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DESCRIPTION OF THE INCIDENT: THIS INTRAPROSTATIC IMPLANT WAS NOT DELIVERED BY UROLIFT DEVICE. ANOTHER IMPLANT WAS USED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246701 UROLIFT UL400 DELIVERY DEVICE & IMPLANT IMPLANTABLE TRANSPROSTATIC TIS PEW NEOTRACT, INC. 73E2400575 00814932020087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown