BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 21894276 · Received April 23, 2025

    Report

    Report Number
    3015181082-2025-00048
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 23, 2025
    Manufacturer
    HUDSON RESPIRATORY CARE TECATE
    Product Code
    PEW
    PMA / PMN Number
    K193269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT EVALUATION TESTING WAS PERFORMED FROM THE SAMPLE RETURNED. UPON COMPLETION OF THE INVESTIGATION, THE REPORTED INCIDENT OF ¿PULL THROUGH DID NOT WORKED. NEEDLE BLOCKED / PUSHED BACK¿ WAS CONFIRMED BASED ON THE FAILURE MODE OF CT DID NOT UNSHEATHE. ANALYSIS PERFORMED REVEALED THAT THE DEVICE ENCOUNTERED THE FOLLOWING FAILURE MODES: 1) NEEDLE BROKEN. THE NEEDLE WAS FOUND WITH A BROKEN NEEDLE PROXIMAL TO THE SPOOL. THE BREAK INTERFACE IS FOUND TO MATCH, AND THERE ARE NO MISSING FRAGMENTS TO REPORT. THE ROOT CAUSE OF THIS FAILURE MODE IS BONE STRIKE. 2) NEEDLE BENT. THE DISTAL NEEDLE TIP WAS FOUND BENT. THE ROOT CAUSE OF THIS FAILURE MODE IS BONE STRIKE. 3) CT DID NOT UNSHEATHE. THE ROOT CAUSE OF THIS FAILURE MODE IS BONE STRIKE. IT IS NOT POSSIBLE TO DETERMINE IF THE CAUSE OF THE BONE STRIKE WAS ¿DEVICE POSITION/USER RELATED¿ OR ¿PATIENT ANATOMY¿. NEOTRACT, INC. WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON MARCH 04, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿THE PULL-THROUGH DID NOT WORK AND THE NEEDLE WAS BLOCKED/PUSHED BACK. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS FINE." ADDITIONAL INFORMATION RECEIVED ON MARCH 10, 2025, INDICATED THAT ¿THE PROCEDURE TOOK PLACE ON (B)(6) 2025, AND WAS COMPLETED WITHOUT ANY REPORTED ADVERSE EVENTS¿. ON APRIL 10, 2025, THE INVESTIGATION OF THE RETURNED DEVICE FOUND THE NEEDLE TO BE BROKEN. THE NEEDLE WAS OBSERVED TO BE FRACTURED PROXIMALLY TO THE SPOOL. THE FRACTURE SURFACES WERE FOUND TO MATCH, AND NO MISSING FRAGMENTS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726879 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW HUDSON RESPIRATORY CARE TECATE UROLIFT SYSTEM 73D2401085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male