BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 23294129 · Received October 15, 2025

    Report

    Report Number
    2024168-2025-11094
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    November 18, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION AND BENDS AND KINKS WERE CONFIRMED. THE REPORTED DIFFICULT TO ADVANCE AND DIFFICULT TO REMOVE COULD NOT BE TESTED AS IT WAS RELATED TO PROCEDURAL CIRCUMSTANCES. 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 OBSERVATIONS FROM THE RETURNED ANALYSIS, THE REPORTED DIFFICULTIES OF DIFFICULT TO ADVANCE, KINK AND TWISTING, DIFFICULT TO REMOVE AND MATERIAL SEPARATION APPEAR TO BE DUE TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT THE RESISTANCE DURING ADVANCEMENT WAS THE RESULT OF CHALLENGING ANATOMICAL CONDITIONS WHICH WERE REPORTED TO BE SEVERELY CALCIFIED. ADVANCING AGAINST RESISTANCE LIKELY CAUSE THE WIRE TO KINK AND DURING REMOVAL, DIFFICULTY WAS ENCOUNTERED AND THE WIRE SEPARATED. 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

    IT WAS REPORTED THAT THE PRESSUREWIRE X (PWX) ¿ WIRELESS DEVICE WAS INTENDED TO BE USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSED. THE PWX WAS ADVANCED. RESISTANCE WAS NOTED WITH THE SEVERE CALCIFICATION AND THE DEVICE BECAME TWISTED AND BENT DUE TO THE NARROW VESSEL. DURING REMOVAL, RESISTANCE WAS NOTED AGAIN, AND THE DEVICE SEPARATED INTO TWO PIECES. THE PWX WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PWX DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993483 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 50212G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown