BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 6197350 · Received December 21, 2016

    Report

    Report Number
    3005791775-2016-00005
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 8, 2016
    Report Date
    December 21, 2016
    Manufacturer
    NEOTRACT INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K133281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TREATED AS PART OF AN ONGOING IDE STUDY WITH A COMMERCIAL DEVICE. TREATING PHYSICIAN INITIATED A COMPLAINT TO DOCUMENT A FAILURE TO IMPLANT A DEVICE IN PATIENT'S LEFT LATERAL LOBE; PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. RETURNED DEVICE WAS RECEIVED ON 18 NOVEMBER 2016 AND ANALYZED 22 NOVEMBER 2016. IT WAS NOTED THAT A NEEDLE TIP FRAGMENT OF APPROXIMATELY 35 MM IN LENGTH WAS MISSING FROM THE RETURNED DEVICE. THE NEEDLE BREAK WAS RECORDED IN THE PROCEDURAL CYSTOSCOPY VIDEO WITHOUT CONFIRMATION AS TO WHETHER THE NEEDLE FRAGMENT WAS DETACHED FROM THE DEVICE OR NOT. PHYSICIAN WAS NOTIFIED AND CONDUCTED A FOLLOW-UP CYSTOSCOPY ON (B)(6) 2016. NO NEEDLE FRAGMENTS WERE IDENTIFIED DURING FOLLOW UP CYSTOSCOPY. PATIENT IS SATISFIED WITH PROCEDURAL OUTCOME, EXPERIENCING REDUCTION IN LUTS WITHOUT ADVERSE SEQUELAE. PATIENT CONTINUES TO BE FOLLOWED IN CLINICAL STUDY AND UNDER THE NORMAL ROUTINE CARE OF HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845022 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT INC. UL400 P33045 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention