BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 SOFT 4MM X 8CM

    MDR report key: 3241494 · Received July 22, 2013

    Report

    Report Number
    3008853977-2013-00247
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 4, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE FOUND THAT THERE WERE NO ANOMALIES NOTED TO THE DELIVERY WIRE. THE DELIVERY WIRE WAS NOT BROKEN. THE PROXIMAL CONTACT WAS FOUND TO BE BROKE OFF THE PROXIMAL END OF THE DELIVERY WIRE. THE MAIN COIL WAS KINKED AND STRETCHED. THERE WERE NO ANOMALIES NOTED TO THE MAIN JUNCTION OR THE FORM TIP BALL. AS THERE ARE ONLINE INSPECTIONS TO THE PROXIMAL CONTACT JOINT ANGLE AT THE LAST STATION BEFORE THE DEVICE IS LOADED INTO THE DISPENSER HOOP, POUCHED AND THEN BOXED WHICH RENDERS IT EXTREMELY UNLIKELY THAT THIS DAMAGE OCCURRED BEFORE THE UNIT LEFT THE PLANT. THEREFORE, A PROBABLE ROOT CAUSE OF SHIPPING DAMAGE HAS BEEN ASSIGNED TO THE PROXIMAL CONTACT BREAKAGE. A PROBABLE ROOT CAUSE OF HANDLING DAMAGE HAS BEEN ASSIGNED TO THE OBSERVED MAIN COIL KINK AND STRETCH AS IT IS MOST LIKELY RELATED TO THE MANNER THE DEVICE WAS HANDLED DURING PREPARATION. THE PROXIMAL CONTACT IS A COMPONENT OF THE DEVICE LOCATED AT THE PROXIMAL END OF THE PUSHER WIRE AND REMAINS OUTSIDE THE PATIENT AT ALL TIMES DURING THE PROCEDURE; THERE IS NO CONTACT WITH THE PATIENT. MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELIVERY WIRE WAS FOUND TO BE BROKEN AS THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DELIVERY WIRE WAS FOUND TO BE BROKEN AS THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340262 TARGET 360 SOFT 4MM X 8CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15302581

    Patients

    Seq Age Sex Outcome Treatment
    1