BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2200339 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05665
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. A REVIEW OF THE INCIDENT INFORMATION WAS PERFORMED; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. POTENTIAL FACTORS THAT COULD CAUSE THIS TYPE OF LEAK OF CONTRAST EXITING THE GUIDE WIRE PORT INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE TO THE SIDEARM/INFLATION LUMEN OR INSUFFICIENT ADHESIVE AT THE INFLATION LUMEN/SIDEARM JUNCTION. A SEARCH OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS FOR THE LOT. BASED ON THE REPORTED INFORMATION, AND THE LOCATION OF THE REPORTED LEAK, IT IS POSSIBLE THAT AN INSUFFICIENT ADHESIVE BOND BETWEEN THE INFLATION LUMEN AND THE SIDEARM CONTRIBUTED TO THE LEAK. THE SECOND ARMADA IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CALCIFIED TIBIAL ARTERY, THE ARMADA 14 BALLOON WAS INFLATED ONE TIME TO 12 ATMOSPHERE (ATM) BUT THE BALLOON COULD NOT HOLD THE PRESSURE; IT WAS NOTED THAT CONTRAST MEDIUM EXITED FROM THE DEVICE AT THE LEVEL OF THE GUIDE WIRE NOTCH. A SECOND ARMADA 14 BALLOON WAS INFLATED ONCE AT 12 ATMOSPHERE (ATM) WITH THE SAME RESULT. A THIRD ARMADA 14 WAS USED SUCCESSFULLY IN THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 732040

    Patients

    Seq Age Sex Outcome Treatment
    1