BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 DETACHMENT HANDLE

    MDR report key: 2080175 · Received April 7, 2011

    Report

    Report Number
    3005168196-2011-00160
    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: THE HANDLES APPEAR NORMAL WITH NO OBVIOUS EXTERNAL DAMAGE. THE HANDLES WERE EACH RE-TESTED USING PRODUCTION TEST FIXTURES. EACH HANDLE PASSED ITS OPERATIONAL TEST FOR PULL FORCE AND THROW DISTANCE. THE HANDLES ARE EACH FULLY FUNCTIONAL. CONCLUSION: THE DIFFICULTY THE PHYSICIAN HAD IN GETTING THE COILS TO RELEASE DURING THIS CASE APPEARS TO BE RELATED TO THE PHYSICIAN'S MANIPULATION OF THE PROXIMAL END OF THE PUSHER ASSEMBLY WITH THE HANDLE DURING THE DETACHMENT PROCESS. SPECIFICALLY, THE COMPLAINT NOTED THAT THE PHYSICIAN REPEATEDLY BENT THE DETACHMENT HANDLE AFTER THE PUSHER WAS SEATED IN THE FUNNEL FEATURE, WHICH WOULD INDUCE A SIGNIFICANT AMOUNT OF FRICTION BETWEEN THE PULL WIRE AND THE PROXIMAL END OF THE PUSHER. THIS WAS LIKELY A USER ERROR AND DID NOT INVOLVE A DEVICE MALFUNCTION. 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 3005168196-2011-00162.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F18238

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR