BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2132654 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04300
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE ARMADA DILATATION CATHETER FOUND THAT IT WAS RETURNED WITHOUT BLOOD VISIBLE AND WITH CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON, CONSISTENT WITH THE REPORTED USE. THE BALLOON WAS TIGHTLY FOLDED, INDICATING THAT IT HAD NOT BEEN INFLATED AS REPORTED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO INFLATE THE BALLOON TO 14 ATMOSPHERES (RBP) WHEN FLUID WAS OBSERVED SLOWLY LEAKING THROUGH THE GUIDE WIRE PORT OF THE HUB. THERE WAS NO BALLOON RUPTURE NOTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOUND NO OTHER INCIDENTS REPORTED FOR THIS LOT. BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED PRODUCT, IT IS LIKELY THAT AN INSUFFICIENT ADHESIVE BOND BETWEEN THE INFLATION LUMEN AND THE SIDEARM CONTRIBUTED TO THE LEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DILATATION CATHETER DID NOT CROSS THE LESION IN THE POPLITEAL ARTERY. THE PATIENT WAS TREATED SATISFACTORILY WITH ANOTHER 2.0 X 20 MM ARMADA. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED A LEAK IN THE HUB OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 704399

    Patients

    Seq Age Sex Outcome Treatment
    1