BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿

    MDR report key: 21439253 · Received February 21, 2025

    Report

    Report Number
    2024168-2025-01978
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 27, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    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. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION WAS 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 MATERIAL SEPARATION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE GUIDEWIRE WAS NOTED TO BE DAMAGED (KINKED, BENT, AND STRETCHED), WHICH RESULTED IN THE REPORTED MATERIAL SEPARATION. IN THIS CASE, IT IS LIKELY THAT THE RESISTANCE ENCOUNTERED DURING WITHDRAWAL OR THE PATIENT¿S ANATOMICAL CONDITIONS CAUSED THE MATERIAL SEPARATION. 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, WIRELESS (PWX) DEVICE AND DRAGONFLY OPSTAR IMAGING CATHETER (DF) WERE TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION AND DISTAL RIGHT CORONARY ARTERY (DRCA). THERE WAS RESISTANCE AT THE STENT WHEN REMOVING THE IMAGING CATHETER FROM THE VESSEL. HOWEVER, ONCE REMOVED, THE PWX WAS NOTED TO BE SEPARATED AND THE TIP OF THE DEVICE WAS ATTACHED TO THE DF. SNARE WAS USED TO REMOVED THE TIP OF THE PWX. IT IS UNKNOWN HOW THE PROCEDURE COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044450 PRESSUREWIRE¿ CATHETER TIP PRESSURE TRANSDUCER DXO LIGHTLAB IMAGING, INC. C12059 40923G1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention