BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 - DETACHMENT HANDLE

    MDR report key: 2142135 · Received May 26, 2011

    Report

    Report Number
    3005168196-2011-00229
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THERE WERE NO NOTICEABLE DEFECTS WITH EITHER HANDLE. THE UNITS WERE TESTED FOR PULL FORCE AND THROW DISTANCE ON THE PRODUCTION TEST FIXTURE. BOTH UNITS PASS THE APPLIED TESTS. THIS ALSO CONFIRMS THE HANDLE FUNNEL IS WITHIN SPECIFICATION. BOTH HANDLES ARE FULLY FUNCTIONAL. CONCLUSION: THE HANDLES WERE RETURNED AS PART OF A GENERAL COMPLAINT ABOUT THE DIFFICULTY OF DETACHING COILS IN THIS PATIENT. THE HANDLES DID NOT CONTRIBUTE TO THE DETACHMENT ISSUES. 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 WAS ATTEMPTING TO COIL AN UNRUPTURED, RIGHT, 11 MM BASILAR ARTERY ANEURYSM IN A PATIENT WITH VERY TORTUOUS ANATOMY. THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE FIRST COIL USING A PENUMBRA COIL 400 DETACHMENT HANDLE, EACH TIME UNSUCCESSFULLY. THE PHYSICIAN WITHDREW THE COIL, AND ATTEMPTED TO PLACE ANOTHER COIL WITH A NEW DETACHMENT HANDLE. AFTER SEVERAL UNSUCCESSFUL TRIES WITH THE HANDLE, THE PHYSICIAN TRIED TO MANUALLY SEPARATE THE PULL WIRE BY HAND. THIS ATTEMPT ALSO FAILED TO DEPLOY THE COIL. THE PHYSICIAN COMMENTED THAT AS HE PULLED ON THE PULL WIRE, HE FELT A STRETCHINESS IN THE WIRE AND A REFLUX BACK ON EACH PULL LIKE A RUBBER BAND. THE PHYSICIAN THEN DECIDED TO REMOVE THE COIL, WHICH RESULTED IN THE COIL DETACHING INSIDE THE PENUMBRA PX400 MICROCATHETER. HE THEN DECIDED TO PUSH THE COIL BACK INTO THE ANEURYSM WITH THE PUSHER. THE COIL WAS SUCCESSFULLY ABLE TO BE REDEPLOYED BACK INTO THE ANEURYSM. THE PHYSICIAN REMOVED THE PX400 AND USED ANOTHER PRODUCT TO COMPLETE THE COILING. THE PATIENT WAS ALERT AND INTACT AFTER THE PROCEDURE. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00228 THROUGH 3005168196-2011-00232.

    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 72 YR