BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 DETACHMENT HANDLE

    MDR report key: 2841057 · Received November 20, 2012

    Report

    Report Number
    3005168196-2012-00400
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE PROXIMAL END OF THE PUSHER IS CAUGHT INSIDE THE HANDLE. THE HANDLE HAD TO BE DISASSEMBLED BEFORE THE PUSHER COULD BE REMOVED. THE HANDLE WAS TESTED ON THE PRODUCTION TEST FIXTURE AND WAS TESTED FOR THROW FORCE AND THROW DISTANCE. THE HANDLE PASSED FOR BOTH TESTS. THE HANDLE IS FULLY FUNCTIONAL. CONCLUSION: THE DAMAGE NOTED IN THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE JAMMED PUSHER WIRE WAS THE DOUBLE ACTUATION OF THE PULL WIRE AS NOTED IN THE COMPLAINT. THIS IS A KNOWN PROBLEM WITH MULTIPLE ACTUATIONS. THE DETACHMENT HANDLE HAS INTERNAL JAWS THE GRAB THE PULL TUBE WHILE THE PUSHER HYPOTUBE IS HELD AGAINST THE THROAT OF THE HANDLE. WHEN THE TRIGGER IS ACTUATED THESE JAWS PULL THE PULL TUBE BACK APPROXIMATELY 1.0 CM AND THEN RELEASE IT. IF THE HANDLE IS ACTUATED A SECOND TIME, THE PULL TUBE CAN BE DRAWN IN EVEN FURTHER TO THE POINT WHERE THE PROXIMAL END IS JAMMED AGAINST THE JAW MECHANISM, CAUSING IT TO HOOK AND MAKING IT DIFFICULT TO REMOVE THE PUSHER ASSEMBLY FROM THE HANDLE. THIS IS NOT A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE PHYSICIAN EXPLAINED THAT HE USED ONE COIL FOR LARGE CERVICAL PSEUDOANEURYSM BEHIND A CAROTID STENT. HE DETACHED COIL AND TOOK THE END OUT OF DETACHMENT HANDLE, THEN REPLACED TO FIRE IT AGAIN TO MAKE SURE THE COIL WAS DETACHED AND THE PROXIMAL END OF COIL WIRE STUCK IN HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 DETACHMENT HANDLE HCG, KRD KRD PENUMBRA, INC. F23336

    Patients

    Seq Age Sex Outcome Treatment
    1