BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 24618010 · Received March 17, 2026

    Report

    Report Number
    2024168-2026-01051
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    October 27, 2025
    Report Date
    March 17, 2026
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAULTY PRESSURE REGISTRATION WAS NOT ABLE TO BE CONFIRMED. 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 FAULTY PRESSURE REGISTRATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THE DEVICE WAS RETURNED WITH DAMAGE TO THE PRESSURE SENSOR OF THE GUIDEWIRE, WHICH RESULTED IN THE REPORTED AND CONFIRMED PRESSURE REGISTRATION ISSUE. THE PRESSURE SENSITIVITY OF THE GUIDEWIRE IS TESTED DURING THE MANUFACTURING PROCESS AND PRIOR TO RELEASE TO DEVICE FUNCTIONALITY UPON EXPECTED USE. IN THIS CASE, IT IS LIKELY THAT THE DAMAGE TO THE PRESSURE MEMBRANE OF THE SENSOR CHIP OCCURRED DUE TO THE HANDLING OR USE TECHNIQUES EMPLOYED. 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, THE PWX DEVICE WAS CALIBRATED SUCCESSFULLY. WHILE ATTEMPTING EQUALIZATION, THERE WAS A LARGE DIFFERENCE BETWEEN THE PA AND PD VALUE, AND EQUALIZATION COULD NOT BE ACHIEVED. THE TRANSMITTER WAS GREEN. THEREFORE, THE DEVICE WAS 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 PRODUCT RETURN INVESTIGATION, IT WAS OBSERVED THAT THERE WAS A BREAK IN THE PRESSURE SENSOR MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283764 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 50619G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown