BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 24774958 · Received April 3, 2026

    Report

    Report Number
    2024168-2026-01343
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 1, 2026
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL TESTING, ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED PRESSURE SIGNAL ISSUE WAS 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 PRESSURE SIGNAL DRIFT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THE DEVICE WAS RETURNED WITH DAMAGE (BREAK) TO THE SENSOR MEMBRANE OF THE GUIDEWIRE, WHICH RESULTED IN THE REPORTED AND CONFIRMED PRESSURE SIGNAL DRIFT. IN THIS CASE, IT IS LIKELY THAT THE SENSOR CHIP DAMAGE WAS CAUSED BY THE HANDLING TECHNIQUES EMPLOYED DURING DEVICE PREPARATION (WIPING). 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 AND EQUALIZATION WERE SUCCESSFUL. HOWEVER, A DRIFT OCCURRED DURING THE PROCEDURE. 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 AND AFTER CLEANING, THE SENSOR WAS RE-EXAMINED, REVEALING A BREAK IN THE SENSOR PAD MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289773 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 51215G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown