BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOVUE EMPOWER

    MDR report key: 15152314 · Received August 2, 2022

    Report

    Report Number
    3005099803-2022-04195
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    February 11, 2020
    Report Date
    August 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFY
    UDI-DI
    08714729977612
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER: THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE DEVICE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO A LITHOVUE FLEXSCOPE, LITHOVUE EMPOWER, AND ZERO TIP BASKETS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THROUGH A POST MARKET CLINICAL FOLLOW UP (PMCF) OF RETROSPECTIVE DATA COLLECTION, THAT A LITHOVUE FLEXSCOPE ALONG WITH A LITHOVUE EMPOWER WERE USED DURING A CYSTOURETHROSCOPY WITH LEFT URETERAL STENT PLACEMENT, LEFT RETROGRADE PYELOGRAM WITH FLUOROSCOPIC INTERPRETATION, LEFT URETEROSCOPY WITH STONE EXTRACTION WITHOUT LASER, RIGHT URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. DURING PROCEDURE, IT WAS NOTED A FOCAL TEAR IN THE MUCOSA OF THE DISTAL/MID URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719353 LITHOVUE EMPOWER ADAPTOR, BULBS, MISCELLANEOUS, FOR ENDOSCOPE FFY BOSTON SCIENTIFIC CORPORATION M0067919900 08714729977612

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other