BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3092789 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02782
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE LEAK FROM THE DISTAL TIP OF THE BALLOON COULD NOT BE CONFIRMED; HOWEVER, A LEAK WAS OBSERVED FROM THE GUIDE WIRE PORT OF THE HUB. WHILE A SEARCH OF THE LOT HISTORY RECORD FOR THIS SPECIFIC LOT INDICATED NO RELATED NON-CONFORMANCE RECORDS, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED TO LEAKAGE AT THE HUB WAS IDENTIFIED. THE PROBABLE CAUSE OF THE HUB LEAKAGE WAS RELATED TO THE ADHESIVE MATERIAL USED DURING THE COMPONENT BONDING PROCESS. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE ARE IN THE PROCESS OF BEING IMPLEMENTED AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL ARMADA 14 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ANTERIOR TIBIAL ARTERY, BELOW THE BIFURCATION, THAT WAS NARROW, MILDLY CALCIFIED AND 90% STENOSED. THE ARMADA 1.5 X 120MM X 90CM BALLOON WAS PLACED IN THE TARGET LESION; HOWEVER, THE BALLOON DID NOT INFLATE AT ALL AND CONTRAST MEDIA WAS OBSERVED LEAKING OUT OF THE DISTAL TIP OF THE BALLOON CATHETER. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE ARMADA 2.0 X 200MM X 90CM WAS THEN PLACED IN THE TARGET LESION; HOWEVER, THE BALLOON DID NOT INFLATE AT ALL AND AGAIN CONTRAST MEDIA WAS OBSERVED LEAKING OUT OF THE DISTAL TIP OF THE BALLOON CATHETER. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. ANOTHER ARMADA BALLOON CATHETER (UNKNOWN SIZE) WAS USED SUCCESSFULLY FOR TREATMENT WITH A SATISFACTORY RESULT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193991 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 721581

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: HT COMMANDSHEATH: CORDIS