BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2142154 · Received May 26, 2011

    Report

    Report Number
    3005168196-2011-00232
    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: THE DISTAL END OF THE PUSHER WAS EXAMINED UNDER MAGNIFICATION. THERE WERE NO DEFECTS ON THE DISTAL DETACHMENT TIP FULCRUM OR ALIGNMENT FEATURE, THE PULL WIRE PET BUMP, OR THE PROXIMAL CONSTRAINT. THERE WAS A SIGNIFICANT AMOUNT OF CLOTTED BLOOD AROUND THESE COMPONENTS. THE PUSHER SHAFT WAS EXAMINED WITH UNAIDED EYE. THERE WERE NO DEFECTS OR KINKS ALONG THE SHAFT LENGTH. THE PET LOCK ON THE PROXIMAL END WAS BROKEN BUT THE PULL TUBE WAS NOT FULLY RETRACTED. THIS OBSERVATION IS CONSISTENT WITH A DEVICE WHERE DETACHMENT WAS ATTEMPTED BUT UNSUCCESSFUL. TO TEST THE FUNCTIONALITY OF THE DEVICE, THE PULL WIRE WAS WITHDRAWN MANUALLY IN AN ATTEMPT TO DETACH THE COIL. EVEN WITH A SIGNIFICANT AMOUNT OF CLOTTED BLOOD IN THE DETACHMENT ZONE, THE COIL DETACHED EASILY. THE COIL/PUSHER ASSEMBLY IS FULLY FUNCTIONAL. CONCLUSION: THERE IS NO EVIDENCE OF DEVICE-RELATED DEFECTS ON EITHER COMPONENT. THE LIKELY CAUSE OF DETACHMENT DIFFICULTY WAS EXCESSIVE TORTUOSITY-RELATED FRICTION BETWEEN THE PULL WIRE AND PUSHER. 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 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 HCG, KRD HCG PENUMBRA INC. F19470

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR