BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY OPSTAR¿

    MDR report key: 21437940 · Received February 21, 2025

    Report

    Report Number
    2024168-2025-01980
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 12, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DQO
    UDI-DI
    05415067031112
    PMA / PMN Number
    K192019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY REMOVING THE CATHETER WAS UNABLE TO BE CONFIRMED DUE TO THE OPERATIONAL CONTEXT OF THE REPORTED ISSUE. 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 DIFFICULTY REMOVING THE CATHETER APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. THE CATHETER WAS NOTED TO BE DAMAGED (KINKED AND STRETCHED SHEATH, AND TORN GUIDE WIRE EXIT NOTCH) WHICH IS CONSISTENT AS AN EFFECT OF THE REPORTED DIFFICULTY TO REMOVE CATHETER, BUT COULD NOT BE DIRECTLY ATTRIBUTED AS THE CAUSE FOR THE DIFFICULTIES. IN THIS CASE, IT IS LIKELY THAT THE CATHETER WAS NAVIGATED TOO FAR ALONG THE GUIDEWIRE AND ONTO THE DISTAL TIP COIL, WHICH RESULTED IN THE REPORTED WITHDRAWAL DIFFICULTY. 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. 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.

    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.

    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 PWX. IT IS UNKNOWN HOW THE PROCEDURE COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543907 DRAGONFLY OPSTAR¿ CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO LIGHTLAB IMAGING, INC. 1014652 10342416 05415067031112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown