BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 3981526 · Received August 5, 2014

    Report

    Report Number
    2024168-2014-04954
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LEAK WAS UNABLE TO BE CONFIRMED. DURING FUNCTIONAL TESTING, USING A PROXY INDEFLATOR FILLED WITH WATER, THE BALLOON INFLATED AND HELD PRESSURE WITH NO LEAKS AS REPORTED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR LEAKS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK ON THE ARMADA 35 WHERE IT CONNECTS WITH THE INFLATION DEVICE. THE CONNECTION BETWEEN THE INFLATION DEVICE AND THE ARMADA WAS CONFIRMED TO BE SECURE. ANOTHER BALLOON DILATATION DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457114 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 40403G1

    Patients

    Seq Age Sex Outcome Treatment
    1