BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 22118606 · Received May 30, 2025

    Report

    Report Number
    2024168-2025-05548
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 1, 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
    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 MATERIAL BREAK WAS ABLE TO BE CONFIRMED (TORN DISTAL TUBE); HOWEVER, THE REPORTED FAILURE TO ADVANCE AND REMOVE FROM THE PATIENT¿S ANATOMY WAS NOT ABLE TO BE TESTED DUE TO THE OPERATIONAL CONTEXT INVOLVED. 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, DIFFICULTY TO REMOVE, AND SUBSEQUENT BREAK APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS NOTED TO BE KINKED AND BENT THROUGHOUT, WHICH WHEN TRYING TO ADVANCE THROUGH THE HOSTILE ANATOMY (HEAVY CALCIFICATION) THE RESISTANCE CAUSED THE REPORTED FAILURE TO ADVANCE, DIFFICULTY TO REMOVE, AND SUBSEQUENT BREAK (CONFIRMED DISTAL TUBE TEAR). IN THIS CASE, IT IS LIKELY THE PATIENT¿S ANATOMICAL CONDITION (HEAVY CALCIFICATION) CAUSED THE OBSERVED GUIDEWIRE DAMAGE. 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. D3: CORRECTION (MANUFACTURER ESTABLISHMENT NAME, ADDRESS, CITY AND POSTAL CODE, REGION STATE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSUREWIRE X (PWX) WIRELESS DEVICE WAS TO BE USED IN AN UNSPECIFIED LESION. DUE TO SEVERE CALCIFICATION IN THE PATIENT'S CORONARY ARTERIES THE PWX FAILED TO CROSS THE TARGET LESION AND AFTER REMOVAL OF THE PWX, THE PRESSUREWIRE WAS NOTED TO BE BROKEN, ABOUT 15 CM FROM THE TIP. ANOTHER PWX 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THE PRESSUREWIRE X (PWX) WAS DIFFICULT TO REMOVE AND DIFFICULT TO ADVANCE DUE TO THE ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642430 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 40914G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown