BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT 2 SYSTEM

    MDR report key: 21084785 · Received January 6, 2025

    Report

    Report Number
    3015181082-2025-00034
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 28, 2025
    Manufacturer
    HUDSON RESPIRATORY CARE TECATE
    Product Code
    PEW
    UDI-DI
    10814932020350
    PMA / PMN Number
    K201837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT EVALUATION TESTING WAS PERFORMED FROM THE SAMPLE RETURNED. THE REPORTED INCIDENT OF ¿NEEDLE BROKE DURING THE DEPLOYMENT. DEVICE REMOVED FROM PATIENT REVEALED TIP BROKE¿ WAS CONFIRMED. NO DEVIATIONS OR REMARKS WERE IDENTIFIED IN THE REVIEW OF BATCH RECORDS ON THE REPORTED LOT THAT CAN EXPLAIN THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER ACTIONS WILL BE TAKEN REGARDING THIS COMPLAINT. NEOTRACT, INC. WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, NEOTRACT HAS BEEN MADE AWARE BY A [PHYSICIAN] THAT ¿[PHYSICIAN] PERFORMED UROLIFT PROCEDURE ON (B)(6) 2024, THE FIRST IMPLANT WAS PLACED PROXIMALLY, BUT THE DEVICE DID NOT PERFORM AS EXPECTED DURING PULL 2. IT APPEARED THAT THE NEEDLE BROKE DURING DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT, AND UPON INSPECTION, THE NEEDLE WAS CONFIRMED TO BE BROKEN. THE BROKEN NEEDLE WAS REMOVED FROM THE PATIENT, AND A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.¿ ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, CONFIRMED THAT NO PART OF THE NEEDLE WAS LEFT IN THE PATIENT AND THE NEEDLE, THE CARTRIDGE, AND ENDOSCOPIC IMAGES WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417946 NEOTRACT UROLIFT 2 SYSTEM UROLIFT 2 SYSTEM PEW HUDSON RESPIRATORY CARE TECATE UROLIFT 2 SYSTEM 73C2400343 10814932020350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male