BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 18 PTA CATHETER

    MDR report key: 5698822 · Received June 3, 2016

    Report

    Report Number
    2024168-2016-03596
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 9, 2016
    Report Date
    June 3, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K151317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORDS FOR BOTH DEVICES REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOTS REVEALED NO OTHER INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE ARMADA 18 OTW BALLOON DILATATION CATHETER, FRICTION/RESISTANCE WAS NOTED WITH SOME NON-ABBOTT GUIDE WIRES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ONE OF THE FOLLOWING TWO DEVICE/BDC WAS USED IN THE PROCEDURE: ARMADA 18, 3.0 X 40 X 90 CM.; REF.#: (B)(4), LOT#: 5052141; ARMADA 18, 4.0 X 40 X 90 CM.; REF.#: (B)(4), LOT#: 6010541.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353037 ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1