BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2933692 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00464
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ADVANCING A 3.0MM X 40MM X 150CM ARMADA 14 BALLOON DILATATION CATHETER TO A NON-CALCIFIED LESION IN THE PROXIMAL LEFT POPLITEAL ARTERY, WHILE ATTEMPTING TO INFLATE THE ARMADA 14, THE BALLOON WOULD NOT INFLATE AT ALL. THE UNSPECIFIED INFLATION DEVICE WAS SWITCHED OUT AND THE STOPCOCK WAS SWITCHED OUT, BUT STILL NO INFLATION AT ALL; THE BALLOON WOULD NOT PRESSURIZE AT ALL. NO LEAKS, KINKS OR DAMAGE WERE NOTED ANYWHERE ON THE DEVICE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR WITHDRAWAL. ANOTHER SAME SIZE ARMADA 14 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39101 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 759477

    Patients

    Seq Age Sex Outcome Treatment
    1