BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY¿ OPTIS¿ IMAGING CATHETER

    MDR report key: 15883164 · Received November 29, 2022

    Report

    Report Number
    2024168-2022-12016
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 6, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQO
    UDI-DI
    00183739000654
    PMA / PMN Number
    K141769 
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO REMOVE AND ACTIVATION, POSITION, OR SEPARATION PROBLEM. IT MAY BE POSSIBLE THAT THE USER¿S TECHNIQUE WHEN REMOVING THE DRAGONFLY OVER THE GUIDE WIRE MAY HAVE CONTRIBUTED TO THE INADVERTENT INTERACTION BETWEEN THE DEVICES, RESULTING IN THE REPORTED DIFFICULT TO REMOVE. HOWEVER, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.NA

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL DRAGONFLY OPTIS DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER AND THE PRESSUREWIRE X, WIRELESS (PWX) DEVICE WERE INTENDED TO BE USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WITH MILD CALCIFICATION AND TORTUOSITY. THE PWX DEVICE WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, THE DISTAL MARKER OF THE IMAGING CROSSED INTO THE RADIOPAQUE PORTION OF THE PWX DEVICE. THEREFORE, THE IMAGING CATHETER WAS REMOVED, BUT THEN THE RADIOPAQUE PORTION OF THE PWX DEVICE HAD LOOPED AROUND THE IMAGING CATHETER RESULTING IN THE PWX DEVICE TO BE REMOVED ALONG WITH IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526336 DRAGONFLY¿ OPTIS¿ IMAGING CATHETER DIAGNOSTIC INTRAVASCULAR CATHETER DQO ABBOTT VASCULAR C408646 8588107 00183739000654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown