BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 23639131 · Received November 24, 2025

    Report

    Report Number
    2024168-2025-11737
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    September 21, 2025
    Report Date
    November 24, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMMUNICATION PROBLEM WAS NOT ABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED COMMUNICATION PROBLEM (FLASHING YELLOW LIGHT) APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS RETURNED WITH KINKS, BENDS, TWISTS, AND A CUT/TEAR TO THE DISTAL TUBE MATERIAL OF THE GUIDEWIRE, WHICH WILL CAUSE THE REPORTED COMMUNICATION PROBLEM. IN THIS CASE, IT IS LIKELY THAT THE USE/HANDLING TECHNIQUE EMPLOYED DURING DEVICE INSERTION CAUSED THE OBSERVED GUIDEWIRE DAMAGE WHICH RESULTED IN THE REPORTED FLASHING YELLOW LIGHT. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    REPORTEDLY, TWO PWX DEVICES (50610G1) WERE CALIBRATED SUCCESSFULLY. HOWEVER, THE SIGNAL WAS LOST, AND THE TRANSMITTER BEGAN FLASHING YELLOW WHEN THE DEVICES WERE INSERTED INTO THE PATIENT'S ANATOMY. THEREFORE, THE DEVICES WERE REMOVED AND ANOTHER PWX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING THE PRODUCT RETURN INVESTIGATION FOR (B)(4), THE DISTAL TUBE WAS OBSERVED TO BE TORN AND EXPOSING THE MICRO CABLES AT THE NOTED KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293173 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 50610G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown