BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX DETACHABLE

    MDR report key: 8622150 · Received May 17, 2019

    Report

    Report Number
    2032493-2019-00146
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 23, 2019
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892032950
    PMA / PMN Number
    K123384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FOR EVALUATION AND ANALYZED. THE DELIVERY PUSHER WAS RECEIVED FOR ANALYSIS. THE IMPLANT AND MICROCATHETER WERE NOT RETURNED. THE BODY COIL OF THE PUSHER AND PROXIMAL PORTION DID NOT DISPLAY ANY NOTABLE DAMAGE. THE HEATER COIL OF THE PUSHER DID NOT DISPLAY ANY BURN DAMAGES. THE STRAIN RELIEF WAS FOLDED INWARDS. THE PUSHER'S ELECTRICAL RESISTANCE WAS MEASURED AT 41.8 OHMS, WHICH IS WITHIN SPECIFICATION. THE PUSHER WAS SUCCESSFULLY LOADED AND TRACKED THROUGH A LAB RETAINED HEADWAY 17 MICROCATHETER. THE ATTACHMENT MONOFILAMENT WITHIN THE PUSHER WAS DISSECTED AND THE TIP WAS FOUND STRETCHED . THE IMPLANT MOST LIKELY DETACHED DUE TO EXPERIENCING A PULLING FORCE OVER THE MAXIMUM TENSILE SPECIFICATION, AS INDICATED BY THE PHYSICAL APPEARANCE OF THE ATTACHMENT MONOFILAMENT TIP. THE SOURCE OF THE PULL FORCE COULD HAVE OCCURRED WHEN THE DEVICE BECAME STUCK IN THE MICROCATHETER; HOWEVER, THE PUSHER DOES NOT INDICATE ANY ABNORMALITIES THAT WOULD CAUSE THIS ISSUE. WITHOUT THE IMPLANT A FULL EVALUATION CANNOT BE PERFORMED. THE ROOT CAUSE OF THE DEVICE BECOMING STUCK COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A SEARCH FOR NON-CONFORMANCE ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE OR DIFFICULT COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ATTEMPTS TO PUSH AND PULL THE COIL IN THE MICROCATHETER, THE COIL GOT STUCK. THE COIL WAS REMOVED IN ITS ENTIRETY ALONG WITH THE MICROCATHETER. WHEN THE MICROCATHETER WAS FLUSHED OUTSIDE THE PATIENT, THE COIL WAS FOUND TO BE DETACHED AND CAME OUT OF THE MICROCATHETER. THERE WAS NO REPORTED PATIENT INJURY, INTERVENTION, OR HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415248 AZUR CX DETACHABLE EMBOLIZATION COIL KRD MICROVENTION, INC. MV-AX82040CL 160504LC2 04987892032950

    Patients

    Seq Age Sex Outcome Treatment
    1