BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2853312 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07596
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEFLATION DIFFICULTIES WERE UNABLE TO BE CONFIRMED. THE DIFFICULTIES REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE POPLITEAL ARTERY. THE 3.0 X80 MM ARMADA 14 BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE, PRIOR TO USE IN THE ANATOMY. THE BALLOON CATHETER WAS ADVANCED WITHOUT ISSUE AND INFLATED ONE TIME TO 10 BAR, FOR 21 SECONDS; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. FIVE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, BUT WERE UNSUCCESSFUL; THEREFORE, THE BALLOON WAS REMOVED STILL INFLATED. IT WAS NOTED THAT THERE WAS RESISTANCE NOTED DURING REMOVAL WITH THE ANATOMY AND WITH THE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 768620

    Patients

    Seq Age Sex Outcome Treatment
    1