BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAGONFLY¿ DUO IMAGING CATHETER

    MDR report key: 14164122 · Received April 20, 2022

    Report

    Report Number
    2024168-2022-04280
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 30, 2022
    Report Date
    September 21, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    UDI-DI
    00183739000708
    PMA / PMN Number
    K093857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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 REVEALED NO OTHER SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE FOREIGN BODY ON THE TIP OF THE CATHETER COULD NOT BE DETERMINED. IT MAY BE POSSIBLE THAT DAMAGE OCCURRED TO THE TIP AND/OR GUIDEWIRE EXIT PORT DURING ADVANCEMENT GIVING THE APPEARANCE OF FOREIGN MATERIAL ON THE TIP WHILE OBSERVED ON X-RAY; HOWEVER, WITHOUT HAVING THE DEVICE TO EXAMINE, 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. D9: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FOREIGN BODY ON THE TIP OF THE DEVICE WAS NOT CONFIRMED. 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 REVEALED NO OTHER SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE FOREIGN BODY ON THE TIP OF THE CATHETER COULD NOT BE DETERMINED. RETURNED ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED FOREIGN BODY ON THE TIP OF THE CATHETER. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D9 - DEVICE AVAILABLE FOR EVAL UPDATED FROM 'NO' TO 'YES'. H6 - CODES 4114 AND 3221 REMOVED. CODES 10 AND 213 ADDED. H10 - ADDITIONAL MFG NARRATIVE: REVISED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY THAT WAS MILDLY TORTUOUS AND CALCIFIED. A DRAGONFLY DUO IMAGING CATHETER WAS INSERTED, BUT IN WAS OBSERVED ON X-RAY THAT A FOREIGN BODY WAS ON THE TIP OF THE DEVICE. THE CATHETER WAS PULLED BACK AND IT WAS OBSERVED THE FOREIGN BODY MOVED WITH THE CATHETER. THEREFORE, THE DEVICE WAS REMOVED. NO FOREIGN BODY WAS OBSERVED IN THE ANATOMY ON IMAGING AFTER THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266768 DRAGONFLY¿ DUO IMAGING CATHETER INTRAVASCULAR IMAGING CATHETER NQQ ABBOTT VASCULAR DUO 7928178 00183739000708

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown