BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 24549879 · Received March 9, 2026

    Report

    Report Number
    2024168-2026-00958
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 17, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 FAILURE TO ADVANCE WAS NOT ABLE TO BE CONFIRMED, BUT THE REPORTED MATERIAL SEPARATION WAS VISUALLY 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 FAILURE TO ADVANCE AND MATERIAL SEPARATION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS RETURNED WITH KINKS AND BENDS, WHICH CAUSED THE REPORTED AND CONFIRMED MATERIAL SEPARATION AND FAILURE TO ADVANCE. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE WAS CAUSED BY THE USE OR HANDLING 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

    IT WAS REPORTED THAT DURING DELIVERY OF THE PRESSUREWIRE X (PWX) TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY TARGET LESION, RESISTANCE WAS MET, POSSIBLY DUE TO THE TORTUOUS ANATOMY. IT WAS ALSO POSSIBLE THAT THE RESISTANCE WAS WITH THE GUIDE CATHETER ITSELF (TWO SIDE HOLES, SO IT IS ALSO POSSIBLE THAT THE PWX MAY HAVE PASSED THROUGH A SIDE HOLE, RESULTING IN THE LOSS OF TORQUE CONTROL.) THE TORQUE RESPONSE BECAME INEFFECTIVE PARTWAY THROUGH ADVANCEMENT, AND THE PWX COULD NOT REACH THE TARGET LESION IN THE MID LAD. DURING ADVANCEMENT OF THE PWX, THE GUIDING CATHETER (GC) JUMPED. THE PWX WAS VISUALIZED IN THE AORTA AT THIS POINT. UPON WITHDRAWING THE PWX, A WIRE BREAK (FRACTURE) WAS NOTED APPROXIMATELY 30 CM FROM THE DISTAL TIP (BETWEEN THE GOLD SECTION AND THE GREEN PTFE COATING OF THE PWX), WITH THE DISTAL FRAGMENT REMAINING ATTACHED TO THE GUIDING CATHETER. AFTER THE GUIDING CATHETER WAS CAREFULLY REMOVED FROM THE BODY, THE DISTAL FRAGMENT OF THE PWX WAS REMOVED TOGETHER WITH IT, WITHOUT RESISTANCE. ONCE OUTSIDE THE BODY, THE PWX DISTAL FRAGMENT DETACHED FROM THE GUIDING CATHETER. THE LESION WAS RE-IMAGED USING THE SAME GUIDING CATHETER, AND SINCE NO SIGNIFICANT ISSUES WERE IDENTIFIED, THE PROCEDURE WAS COMPLETED WITHOUT PERFORMING FFR. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450183 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 51024G2 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MEDIKIT 5F SEIHA JL3.5 GUIDING CATHETER