BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2882831 · Received December 20, 2012

    Report

    Report Number
    3005168196-2012-00443
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE COIL IS COMPLETE AND EXCEPT FOR SOME MINOR COIL OFFSETS ATTRIBUTABLE TO HANDLING, THE COIL IS UNDAMAGED. THE PROXIMAL CONSTRAINT BALL IS IN PLACE AND THE COIL APPEARS TO HAVE BEEN NORMALLY RELEASED. THE PUSHER PET LOCK IS BROKEN AND THE TWO PIECES OF THE LOCK ARE SEPARATED BY APPROXIMATELY 3 CM. THE DISTAL DETACHMENT TIP IS EMPTY AND THE PULL WIRE IS NO LONGER IN THE CAPTURE FEATURE. THIS IS A NORMAL POST DEPLOYMENT CONDITION. THE CURRENT STATE OF THE PUSHER AND COIL IS POST SUCCESSFUL RELEASE. THE DEVICE APPEARS TO HAVE FUNCTIONED CORRECTLY. CONCLUSION: THE COMPLAINT MENTIONS A PREMATURE DETACHMENT OF THE COIL WITHOUT MENTIONING ANY ATTEMPT THAT MAY HAVE BEEN MADE TO ACTUATE THE RELEASE MECHANISM. THE STATE OF THE PET LOCK ON THE PUSHER DISAGREES WITH THIS DESCRIPTION OF EVENTS. THE COMPLAINT ALSO NOTES THAT AN IDENTICAL COIL TO THE ONE RETURNED WAS DEPLOYED IMMEDIATELY AFTER THE UNINTENTIONALLY RELEASED COIL. IF THE INCORRECT PUSHER WAS RETURNED WITH THE UNINTENTIONALLY RELEASED COIL, IT WOULD EXPLAIN THE DISCREPANCIES BETWEEN THE PUSHER STATE AND THE EVENTS DESCRIBED. WITHOUT THE RETURN OF THE DEVICE INVOLVED IN THE EVENT, A CONCLUSION AS TO THE ROOT CAUSE OF THE ISSUE CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DELIVERING THE PENUMBRA COIL 400 16MM X 60CM COMPLEX COIL THROUGH A PXSLIM 45 CATHETER AND NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF RESISTANCE FELT WHILE ADVANCING THE COIL. AS HE WITHDREW THE COIL (STILL EXPERIENCING RESISTANCE), THE COIL DETACHED AS IT WAS REMOVED FROM THE PXSLIM CATHETER. THERE WAS NO SIGNIFICANT VESSEL TORTUOSITY. AN ALTERNATE PC400 16MM X 60CM COIL WAS SELECTED AND WAS DELIVERED WITHOUT INCIDENT THROUGH THE SAME PXSLIM 45 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F18616

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR