BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2851269 · Received November 29, 2012

    Report

    Report Number
    3005168196-2012-00410
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR EVALUATION AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL IS ATTACHED TO THE PUSHER ASSEMBLY IN THE PROPER UNDETACHED STATE. THE PROXIMAL PET LOCK IS BROKEN AND THE PULL-WIRE MOVES FREELY INSIDE THE HYPOTUBE. THE COIL DETACHMENT ASSEMBLY IS NON-FUNCTIONAL. THE PET LOCK IS BROKEN AND THE INNER HYPOTUBE HAS MOVED 3.0 CM PROXIMAL OF ITS LOCKED POSITION WHICH SHOULD HAVE CAUSED DETACHMENT OF THE COIL. THE SKIVED SECTION OF THE INNER HYPOTUBE WHERE THE PULL WIRE ATTACHES IS VISIBLE JUST PROXIMAL OF THE BROKEN PET LOCK. THE PULL WIRE WAS TUGGED WITH A PAIR OF TWEEZERS. THE WIRE MOVED EASILY AND SHOWED NO EFFECT ON THE DETACHMENT TIP. AGAIN, MOVEMENT OF THE PULL WIRE SHOULD HAVE CAUSED DETACHMENT OF THE COIL. THE WIRE CAME OUT OF THE EXTERIOR HYPOTUBE AND WAS BROKEN APPROXIMATELY 2.1 CM DISTAL OF ITS ATTACHMENT POINT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY . DURING THE INVESTIGATION, THE FLEXIBLE DISTAL PORTION OF THE PUSHER WAS REMOVED AND THE PULL WIRE WAS REMOVED FROM THE EXTERIOR HYPOTUBE. THE PULL WIRE CAME OUT WITHOUT APPARENT FRICTION. AT THIS POINT THE COIL WAS STILL ATTACHED TO THE DISTAL PUSHER SECTION. THE PULL WIRE WAS GENTLY PULLED AND THE COIL RELEASED AS DESIGNED. CONCLUSION: THE FAILURE TO DETACH NOTED IN THE COMPLAINT IS CONFIRMED. THE CAUSE OF THIS FAILURE WAS A BROKEN PULL WIRE INSIDE THE PUSHER ASSEMBLY. THE CAUSE OF THIS BREAK CANNOT BE DETERMINED. 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

    A STENT WAS PLACED ACROSS A 15 MM FUSIFORM SPLENIC ARTERY ANEURYSM. THE FOURTH COIL TO GO IN WAS A 6X15 SOFT. THE PHYSICIAN TRIED TO DETACH IT SEVERAL TIMES WITH THE DETACHMENT HANDLE WITHOUT SUCCESS. THEN THE PHYSICIAN TRIED TO DETACH THE COIL BY PULLING ON THE DETACHMENT WIRE WITH HEMOSTATS. THIS WAS NOT SUCCESSFUL SO THE COIL WAS RETRACTED WITHOUT INCIDENT. THE PATIENT WAS OK AND ANOTHER 6X15 SOFT COIL TAKEN FROM INVENTORY AND DEPLOYED AND DETACHED WITH NO INCIDENT. THE CASE WAS COMPLETED WITH THE PLACEMENT OF TWO ADDITIONAL COILS AND SUCCESSFUL EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F26644

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR