BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 9541833 · Received January 2, 2020

    Report

    Report Number
    2024168-2020-00111
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 28, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQY
    UDI-DI
    08717648155994
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THE BALLOON INTERACTED WITH THE HEAVY CALCIFICATION DURING PRE-DILATION AND REMOVAL OF THE DEVICE CAUSING THE REPORTED TORN BALLOON AND LEAK. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. A COMMAND GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. THEN THE FIRST 2.0 X 200 MM ARMADA BALLOON DILATATION CATHETER (BDC), LOT # 9070241, WAS ADVANCING ONTO THE GUIDE WIRE, HOWEVER RESISTANCE WAS FELT BECAUSE THE BDC HAD A DISTAL SHAFT KINK. THE KINK WAS OBSERVED PRIOR TO THE BDC ENTERING THE PATIENT. THE BDC WAS REMOVED AND THE PROCEDURE CONTINUED WITH A NEW ARMADA BDC. THE SECOND ARMADA BDC, LOT # 8101641, WAS ADVANCED WITH THE SAME GUIDE WIRE. THE BALLOON WAS SUCCESSFULLY USED TO COMPLETE PRE-DILATATION. HOWEVER, DURING RETRACTION OF THE BDC, BLOOD WAS OBSERVED IN THE INDEFLATOR. THE BDC WAS REMOVED AND A SLICE ACROSS THE BALLOON WAS NOTED WITH CONTRAST LEAKING FROM THE BALLOON. A THIRD ARMADA BDC WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THE TARGET LESION WAS TREATED, AND THE PATIENT IS STABLE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3270 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER DQY ABBOTT VASCULAR A2020-200 8101641 08717648155994

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR