BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 DETACHMENT HANDLE

    MDR report key: 2923412 · Received January 22, 2013

    Report

    Report Number
    3005168196-2013-00029
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE DETACHMENT HANDLES LOOKS TO BE IN ITS ORIGINAL CONDITION. THESE UNITS WERE TESTED AND USING THE PRODUCTION TEST FIXTURE WHICH MEASURES THE THROW DISTANCE AND PULL FORCE. THE DETACHMENT HANDLES ACTUATED CORRECTLY AND PASSED FOR BOTH THROW DISTANCE AND PULL FORCE. THE DETACHMENT HANDLES ARE FULLY FUNCTIONAL. CONCLUSION: THIS HANDLE FUNCTIONED AS EXPECTED DURING TESTING. THE HANDLE PASSED THE SPECIFICATIONS REQUIRED FOR COIL DETACHMENT. THE CAUSE OF THIS FAILURE CANNOT BE DETERMINED. THIS ISSUE DOES NOT APPEAR TO HAVE BEEN DUE TO A DETACHMENT HANDLE FAILURE. THE HANDLE WAS OPENED AND THERE WAS NO BLACK TUBING STUCK INSIDE THE HANDLE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    FIRST COIL WOULD NOT DETACH SO THEY OPENED A SECOND HANDLE AND THE BLACK RUBBER FROM THE PUSHER WIRE GOT STUCK IN THAT HANDLE SO THEY OPENED A 3RD HANDLE. THE COIL DETACHED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29277 PENUMBRA COIL 400 DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F30311

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR