BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 21586071 · Received March 12, 2025

    Report

    Report Number
    3015181082-2025-00041
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 13, 2025
    Report Date
    April 7, 2025
    Manufacturer
    HUDSON RESPIRATORY CARE TECATE
    Product Code
    PEW
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS. NEOTRACT, INC. WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON FEBRUARY 14, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿THE PHYSICIAN FOLLOWED ALL THE STEPS AS EXPECTED; HOWEVER, AT THE URETHRAL ENDPIECE STEP, THE BLUE BUTTON WAS PRESSED, BUT THE SUTURE WAS NOT CUT, AND THE ENDPIECE DID NOT ATTACH. HRT WAS USED TO TROUBLESHOOT THE ISSUE, BUT THE SECTION WHERE IT WAS APPLIED DID NOT MOVE AT ALL (INCOMPLETE CUT). THE SUTURE COULD NOT BE CUT AND HAD TO BE PULLED THROUGH THE SHEATH, LEAVING THE URETHRAL ENDPIECE AT THE END OF THE DEVICE. THE CT (CONNECTOR TIP) AND SUTURE WERE NOT REMOVED AT THAT POINT AND WERE LATER LOCATED WITH FORCEPS. HRT WAS TRIED AGAIN AFTER THE PROCEDURE, BUT IT WAS NOT POSSIBLE TO MOVE THE CUT SECTION. DURING THE PROCEDURE, FIVE IMPLANTS WERE PLACED: IMPLANT 1 (PROXIMAL TO THE BLADDER NECK) ON THE PATIENT¿S LEFT SIDE WAS DEPLOYED WITHOUT ISSUES; IMPLANT 2 (PROXIMAL TO THE BLADDER NECK) ON THE RIGHT SIDE WAS DEPLOYED CORRECTLY BUT TOO CLOSE TO THE BLADDER NECK; IMPLANT 3 (DISTAL TO THE BLADDER NECK) ON THE LEFT SIDE WAS DEPLOYED WITHOUT ISSUES; IMPLANT 4 (DISTAL TO THE BLADDER NECK) ON THE RIGHT SIDE, BONE STRIKE, WAS NOT DEPLOYED, AND WAS NOT RECOVERED; AND IMPLANT 5 (DISTAL TO THE BLADDER NECK) ON THE RIGHT SIDE HAD AN INCOMPLETE CUT AND THE HRT FAILED TO WORK. AFTER THE INCIDENT WITH IMPLANT 5, THE CONSULTANT DECIDED TO ABORT THE PUL PROCEDURE DUE TO BLEEDING, USING DIATHERMY TO CONTROL IT AND IMPROVE VISIBILITY. THERE WAS NO VISIBILITY OF THE CT AND SUTURE, SO IT WAS ASSUMED THEY WERE LEFT IN THE LATERAL LOBE. THE PHYSICIAN ATTEMPTED TO REMOVE IMPLANT 2 DUE TO LIMITED VISIBILITY; ALTHOUGH IT WAS DIFFICULT TO LOCATE, THE CT ENDPIECE WITH THE ATTACHED SUTURE WAS EVENTUALLY REMOVED USING FORCEPS. IT IS BELIEVED THAT THIS PIECE BELONGED TO IMPLANT 5, ALTHOUGH THE CONSULTANT THOUGHT IT WAS FROM IMPLANT 2. THIS RAISED CONCERNS THAT A URETHRAL ENDPIECE (UE) WAS MISSING, LEADING TO A BLADDER WASH AND FILTER CHECK. IMAGING OF THE PATIENT WAS RECOMMENDED. ADVICE WAS SOUGHT FROM CMA, AND THE PROCEDURE WAS ABORTED, WITH DIATHERMY USED TO CONTROL BLEEDING AND IMPROVE VISIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111812 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW HUDSON RESPIRATORY CARE TECATE UROLIFT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male