BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA¿

    MDR report key: 23117404 · Received September 22, 2025

    Report

    Report Number
    2024168-2025-10139
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, AND INTERACTIONS WITH OTHER DEVICES OR LESION CALCIFICATION. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND LIMITED INFORMATION WAS REPORTED. 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 VESSEL IN THE LEFT LEG. A 6F 55CM COOK SHEATH WAS USED ACCESSING THE RIGHT GROIN. AFTER THE USE OF A CARDIOVASCULAR SYSTEMS, INC. (CSI) DEVICE, A 3.0X200MM ARMADA 14 BALLOON DILATATION CATHETER WAS TO BE USED FOR POST-DILATION. ONCE AT THE LESION, THE ARMADA BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE AND HELD FOR 2 MINUTES, TWICE. THE ARMADA BALLOON BURST AT THE RATED BURST PRESSURE, DURING THE SECOND INFLATION. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581239 ARMADA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT ABBOTT VASCULAR INC. A2030-200 4111241

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male