BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT ATC SYSTEM

    MDR report key: 14296708 · Received May 6, 2022

    Report

    Report Number
    3015181082-2022-00007
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 11, 2022
    Report Date
    May 4, 2022
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020145
    PMA / PMN Number
    K200441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THREE DEVICES DID NOT PROPERLY DEPLOY AN IMPLANT (ONE UROLIFT SYSTEM UL400 AND TWO UROLIFT ATC SYSTEM DEVICES). DUE TO CONTINUED OBSTRUCTION, THE CASE WAS CONVERTED INTO A TURP. THE TWO UROLIFT ATC SYSTEM DEVICES WERE RETURNED FOR INVESTIGATION. ON (B)(6) 2022, INVESTIGATION OF ONE OF THE RETURNED DEVICES CONFIRMED 1MM OF THE NEEDLE WAS BROKEN AND NOT ACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND REPORTED THAT THE PATIENT WAS DOING WELL AND NO FURTHER ACTION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693835 NEOTRACT UROLIFT ATC SYSTEM UROLIFT ATC SYSTEM PEW NEOTRACT, INC. UROLIFT ATC SYSTEM P00678 10814932020145

    Patients

    Seq Age Sex Outcome Treatment
    1 Male