BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿

    MDR report key: 23910244 · Received December 29, 2025

    Report

    Report Number
    2024168-2025-12257
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 10, 2025
    Report Date
    February 18, 2026
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE WHICH RESULTED IN VASCULAR DISSECTION AND UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE, IT IS LIKELY THAT THE USE TECHNIQUES EMPLOYED WITH GUIDEWIRE DELIVERY, OR THE PATIENT¿S ANATOMICAL CONDITIONS, CAUSED THE REPORTED FAILURE TO ADVANCE VASCULAR DISSECTION AND UNEXPECTED MEDICAL INTERVENTION. THE REPORTED PATIENT EFFECTS (DISSECTION AND UNEXPECTED MEDICAL INTERVENTION) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DISSECTION IS LISTED IN THE PRESSUREWIRE INSTRUCTION FOR USE AS POTENTIAL COMPLICATIONS WHICH MAY BE ENCOUNTERED DURING ALL CATHETERIZATION PROCEDURES. 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.D9: CORRECTED DEVICE AVAILABLE FOR EVALUATION FROM YES TO NO

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PRESSUREWIRE X (PWX) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AND A DISSECTION OCCURRED. THE PWX WAS REMOVED AND A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND A XIENCE ALPINE STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131572 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 50324G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention