BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA

    MDR report key: 20217954 · Received September 13, 2024

    Report

    Report Number
    2024168-2024-10809
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 16, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LIT
    UDI-DI
    08717648211256
    PMA / PMN Number
    K151317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION, FUNCTIONAL TESTING AND SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED LEAK AND INFLATION ISSUE WERE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT. THE SEM REPORT DETERMINED THE INNER MEMBER LEAK MAY BE ATTRIBUTED TO MECHANICAL DAMAGE INITIATING FROM THE INNER SURFACE. A LINE OF DAMAGE WAS DOCUMENTED LEADING TO THE LEAK FROM THE DISTAL DIRECTION. THE LEAK HAD A PROTRUDED APPEARANCE. MECHANICAL DAMAGE ALONG WITH TORN AND STRETCHED MATERIAL WERE DOCUMENTED AT THE LEAK EDGES. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED LEAK AND INFLATION ISSUE APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE OR DURING PREPARATION, WHICH SUGGESTS A PRODUCT QUALITY ISSUE DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. SEM ANALYSIS NOTED A HOLE IN THE INNER MEMBER INITIATING FROM THE INNER SURFACE AND A LINE OF DAMAGE WAS DOCUMENTED LEADING TO THE LEAK FROM THE DISTAL DIRECTION. IN THIS CASE, IT IS LIKELY THAT THE GUIDE WIRE WAS INADVERTENTLY LOADED ONTO THE BALLOON DILATATION CATHETER (BDC) NOT PROPERLY SUPPORTED OR AT AN ANGLE SUCH THAT THE GUIDE WIRE PUNCTURED THROUGH THE INNER MEMBER WHICH RESULTED IN THE REPORTED LEAK AND INFLATION ISSUE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS AV FISTULA. THE 4.0X60MM ARMADA 18 BALLOON WAS NOTED TO BE LEAKING CONTRAST BETWEEN THE BALLOON AND THE TIP WHEN ATTEMPTING TO INFLATE; HOWEVER, THE BALLOON DID NOT INFLATE. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209277 ARMADA CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT ABBOTT VASCULAR INC. 1014262-060 3101941 08717648211256

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female