BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿

    MDR report key: 23407977 · Received October 28, 2025

    Report

    Report Number
    2024168-2025-11262
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 26, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    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. H6: MEDICAL DEVICE PROBLEM CODE 2017: FAILURE TO FOLLOW STEPS / INSTRUCTIONS.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED PRESSURE SIGNAL DRIFT 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 PRESSURE SIGNAL DRIFT APPEARS TO BE RELATED TO USER ERROR. THE GUIDEWIRE WAS LEFT INSIDE THE PATIENT DURING DEFIBRILLATION AND WAS NOT REMOVED FROM THE PATIENT AND RE-CALIBRATED (ZEROED) INSIDE THE PACKAGING HOOP/COIL PRIOR TO CONTINUING THE PROCEDURE. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU), PRECAUTION STATES ¿GUIDEWIRE READINGS MAY BE AFFECTED BY DEFIBRILLATION. REZERO THE GUIDEWIRE AFTER DEFIBRILLATION USE.¿ IN THIS CASE, IT WAS DETERMINED THAT NOT REMOVING THE GUIDEWIRE FROM THE PATIENT AFTER PERFORMING DEFIBRILLATION AND CONTINUING THE PROCEDURE, DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PRESSURE SIGNAL DRIFT. THE REPORTED PATIENT EFFECT OF SERIOUS ARRHYTHMIAS (VENTRICULAR FIBRILLATION) IS LISTED IN THE PRESSUREWIRE X GUIDEWIRE INSTRUCTION FOR USE AS A KNOWN COMPLICATION THAT MAY OCCUR DURING ALL CATHETERIZATION PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF VENTRICULAR FIBRILLATION RESULTING IN UNEXPECTED MEDICAL TREATMENT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. 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 THE PRESSUREWIRE X, (PWX) WIRELESS DEVICE CALIBRATED AND EQUALIZED SUCCESSFULLY PRIOR TO RESTING FULL-CYCLE RATIO (RFR) MEASUREMENT. FOR (FRACTIONAL FLOW RESERVE) (FFR) MEASUREMENT, INTRACORONARY ADMINISTRATION OF SIGMART WAS CONDUCTED. SUBSEQUENTLY, THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION (VF), AND DIRECT CURRENT DEFIBRILLATOR (DC) WAS USED WHILE THE PWX WAS POSITIONED IN THE CORONARY ARTERY (LAD). AFTER DEFIBRILLATION, THE PWX GUIDEWIRE REMAINED IN THE ANATOMY; EQUALIZATION WAS REPEATED, AND FFR WAS MEASURED. BUT ABNORMALLY HIGH PD AND PA VALUES WERE OBSERVED (PA 105 / PD 132), INDICATING PRESSURE SIGNAL DRIFT. THE PWX WAS REMOVED FROM THE BODY, AORTIC PRESSURE ZEROED AGAIN, AND EQUALIZATION WAS REATTEMPTED. RFR WAS THEN MEASURED AND SHOWED NORMAL VALUES. SIGMART WAS ADMINISTERED AGAIN, AND FFR MEASUREMENT WAS ATTEMPTED, BUT NORMAL VALUES COULD NOT BE OBTAINED. THE TRANSMITTER LIGHT WAS STEADY GREEN. THEREFORE, THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITHOUT USING A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840731 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 40425G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention