BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400 - PUSHER ASSEMBLY

    MDR report key: 2142136 · Received May 26, 2011

    Report

    Report Number
    3005168196-2011-00231
    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. THE PULL WIRE WAS RETRACTED PROXIMAL TO THE DETACHMENT TIP. THERE WERE NO DEFECTS ON THE PET BUMP OR THE DISTAL DETACHMENT TIP. THE COIL IMPLANT WAS NOT PRESENT. THE PROXIMAL END OF THE PUSHER WAS THEN EXAMINED WITH UNAIDED EYE. THE PET LOCK WAS BROKEN AND THE PULL WIRE WAS RETRACTED. THE PULL WIRE MOVED FREELY WITHIN THE PUSHER, ELIMINATING THE POSSIBILITY OF DEFECT-RELATED FRICTION. THESE OBSERVATIONS ARE CONSISTENT WITH A FULLY FUNCTIONAL PUSHER AFTER COIL DETACHMENT AND ARE INCONSISTENT WITH BOTH FACETS OF THE COMPLAINT DESCRIPTION. TO FURTHER CONFIRM THAT ALL COMPONENTS ASSOCIATED WITH THE DETACHMENT PROCESS WERE FULLY FUNCTIONAL, THE DISTAL DETACHMENT TIP ID AND PULL WIRE OD WERE MEASURED. BOTH MEASUREMENTS ARE WITHIN SPEC, AND THE PUSHER IS FUNCTIONAL. CONCLUSION: THE COMPLAINT NARRATIVE DESCRIBED THE INABILITY TO DETACH THE COIL WITHIN THE ANEURYSM FOLLOWED BY THE UNINTENDED DETACHMENT OF THE COIL WITHIN THE MICROCATHETER. THE PUSHER IS FULLY FUNCTIONAL WITH NO EVIDENCE OF FRICTION BETWEEN THE PUSHER AND PULL WIRE AND NO EVIDENCE OF A PREMATURE DETACHMENT. THE LIKELY CAUSE OF DETACHMENT DIFFICULTY WAS EXCESSIVE TORTUOSITY-RELATED FRICTION BETWEEN THE PULL WIRE AND PUSHER. THE LIKELY CAUSE OF THE UNINTENDED DETACHMENT IN THE MICROCATHETER WAS ALSO RELATED TO EXCESSIVE TORTUOSITY-RELATED FRICTION BETWEEN THE PULL WIRE AND PUSHER: THE MULTIPLE DETACHMENT ATTEMPTS MAY HAVE CAUSED THE PULL TUBE TO "HANG UP" ON THE PROXIMAL END OF THE PUSHER HYPOTUBE, THEREBY LEAVING THE PULL WIRE IN A STATE OF TENSION. AS THE PUSHER WAS WITHDRAWN AND FRICTION FROM TORTUOSITY WAS RELIEVED, THE BUILT-UP TENSION RETRACTED THE PULL-WIRE CAUSING THE DETACHMENT. THE MANUFACTURING RECORDS FOR THIS LOT DID NOT REVEAL ANY DISCREPANCIES.

    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 - PUSHER ASSEMBLY HCG, KRD HCG PENUMBRA INC. F19682

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR