BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL DETACHMENT HANDLE

    MDR report key: 2080164 · Received April 7, 2011

    Report

    Report Number
    3005168196-2011-00162
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A COIL PUSHER ASSEMBLY WAS RETURNED LODGED IN THE DETACHMENT HANDLE. THE PUSHER ASSEMBLY PROXIMAL PET LOCK WAS BROKEN AND THE COIL HAD SUCCESSFULLY BEEN DETACHED. THE PULL-WIRE INNER TUBE WAS JAMMED IN THE DETACHMENT HANDLE. AFTER REMOVING THE TIP OF THE DETACHMENT HANDLE, IT WAS OBSERVED THAT THE PROXIMAL END OF THE PUSHER WIRE WAS BENT. THE BROKEN EDGE OF THE PET LOCK WAS CAUGHT ON THE BACK SIDE OF THE HANDLE ENTRY CONE PREVENTING ITS REMOVAL. THE DETACHMENT HANDLE WAS REASSEMBLED AFTER REMOVING THE PROXIMAL INNER TUBE FROM THE CAP. THE HANDLE WAS TESTED IN THE PRODUCTION TEST FIXTURE AND WAS WITHIN SPECIFICATION FOR BOTH PULL FORCE AND THROW DISTANCE. THE HANDLE IS FULLY FUNCTIONAL. THE PUSHER WIRE WAS USED SUCCESSFULLY; FUNCTIONAL TESTING WAS NOT NECESSARY. CONCLUSION: THE BEND IN THE PROXIMAL SECTION OF THE PUSHER ASSEMBLY MADE IT IMPOSSIBLE TO REMOVE IT FROM THE DETACHMENT HANDLE. THE BEND MAY HAVE BEEN CAUSED BY INSERTING THE COIL PUSHER WIRE AT AN ANGLE AS DESCRIBED IN THE COMPLAINT. MULTIPLE HANDLE ACTUATIONS WHEN ATTEMPTING TO DETACH THE COIL MAY HAVE CAUSED THE EDGE OF THE PET PLASTIC LOCK TO CATCH ON THE BACK SIDE OF THE HANDLE ENTRY CONE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN USED TWO PENUMBRA COIL 400 DETACHMENT HANDLES WITH INTERMITTENT SUCCESS TO DEPLOY APPROXIMATELY THIRTY COILS. A PENUMBRA REPRESENTATIVE REVIEWED THE TECHNIQUE WITH THE PHYSICIAN BEFORE THE CASE AND STRESSED PROPER TECHNIQUE DURING THE CASE. SOMETIMES THE COIL WOULD DETACH AS DESIGNED, OTHERS REQUIRED MULTIPLE ATTEMPTS. IN MANY INSTANCES, THE HANDLE WOULD HOLD ON TO THE MOST PROXIMAL PORTION OF THE BLACK SLEEVE AND REMOVE THE SLEEVE DURING RETRACTION. THE PHYSICIAN SPECULATED THAT THE BLACK SLEEVE MAY BE JAMMING THE MECHANISM INSIDE THE HANDLE. HE WAS MOST SUCCESSFUL WITH DETACHMENT WHEN HE KEPT THE HANDLE IN LINE WITH THE DELIVERY SYSTEM AND REMOVED THE HANDLE IN A STRAIGHT LINE. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00158 THROUGH 3005168196-2011-00161.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F18238

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR