BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY¿ OPTIS¿ IMAGING CATHETER

    MDR report key: 15439923 · Received September 16, 2022

    Report

    Report Number
    2024168-2022-09808
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 2, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQO
    UDI-DI
    00183739000647
    PMA / PMN Number
    K141769 
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PRESSUREWIRE X REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    VISUAL AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICES. THE REPORTED DIFFICULTY REMOVING WAS UNABLE TO BE CONFIRMED DUE TO THE DEVICE CONDITION. ADDITIONALLY, THE DRAGONFLY GUIDEWIRE EXIT NOTCH WAS NOTED TO BE STRETCHED AND TORN DISTALLY. 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 OTHER SIMILAR COMPLAINTS REPORTED FROM THIS LOT.BASED ON THE INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DIFFICULTIES. IT MAY BE POSSIBLE THAT, DURING THE PROCEDURE, THE PRESSUREWIRE WAS INADVERTENTLY KINKED WHILE ATTEMPTING TO ADVANCE. FURTHERMORE, IT MAY BE POSSIBLE THAT THE NOTED KINK ON THE PRESSUREWIRE CAUSED THE DRAGONFLY TO BECOME INADVERTENTLY CAUGHT ON THE GUIDEWIRE. THE STRETCHED AND TORN GUIDEWIRE EXIT NOTCH SUGGESTS THAT THE GUIDEWIRE AND CATHETER WERE LIKELY SPREAD APART DURING REMOVAL. 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.D4: LOT NUMBER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSUREWIRE X,(PWX) DEVICE WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY. THE LESION WAS SUCCESSFULLY TREATED WITH AN UNSPECIFIED BALLOON, SUBSEQUENT TO AN UNSPECIFIED STENT. THE PWX DEVICE REMAINED IN THE PATIENT AND THEN A DRAGONFLY OPTIS IMAGING CATHETER WAS ADVANCED TO THE TREATED LESION TO VERIFY PROPER STENT PLACEMENT. AFTER THE FIRST PULLBACK, THE RUN DID NOT LOOK RIGHT DUE TO UNINTENDED MOVEMENT OF A NON-ABBOTT GUIDE CATHETER THAT LED TO BLOOD FLOW TO SWIRL. THEREFORE, THE PWX DEVICE WAS ADVANCED FURTHER DISTALLY; HOWEVER, THE IMAGING CATHETER WAS STUCK WITH THE PWX DEVICE. BOTH THE PWX DEVICE AND IMAGING CATHETER WERE REMOVED AS A SINGLE UNIT. ONCE BOTH THE PWX DEVICE AND IMAGING CATHETER WERE OUTSIDE THE PATIENT, THE PWX DEVICE WAS ABLE TO BE SEPARATED FROM THE IMAGING CATHETER. IT WAS NOTED THAT THE TIP OF THE PWX DEVICE WAS EXTREMELY CURLED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874272 DRAGONFLY¿ OPTIS¿ IMAGING CATHETER DIAGNOSTIC INTRAVASCULAR CATHETER DQO ABBOTT VASCULAR C408646 8324167 00183739000647

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male