BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3150644 · Received June 6, 2013

    Report

    Report Number
    3005168196-2013-00210
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PUSHER APPEARS TO HAVE A BREAK IN THE HYPO-TUBE PORTION OF THE SHAFT APPROXIMATELY 1.8 CM FROM THE PET LOCK. THE COIL IS DETACHED FROM THE DISTAL DETACHMENT TIP (DDT). THIS DETACHMENT WAS LIKELY DUE TO THE DAMAGE TO THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER AND COIL ARE NON-FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT INDICATES THAT THERE WAS DAMAGE TO THE PUSHER ASSEMBLY WHEN REMOVING THE DEVICE FROM THE PACKAGING. IF THE PRODUCT IS MISHANDLED DURING REMOVAL FROM THE PACKAGING, DAMAGE MAY OCCUR. IT APPEARS THAT THE PUSHER ASSEMBLY WAS BENT DURING REMOVAL FROM THE PACKAGING AND SUBSEQUENTLY BROKE WHEN IT WAS PULLED OUT OF THE HOOP. 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

    PATIENT WAS ON TABLE UNDERGOING RENAL AVF EMBOLIZATION PROCEDURE. PHYSICIAN FOUND DAMAGE TO PENUMBRA 400 COIL WHEN PULLING OUT OF PACKAGING HOOP. THE BACK END OF THE PUSHER ASSEMBLY WAS BENT. IT WAS NOT INTRODUCED INTO THE CATHETER AND DID NOT COME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251033 PENUMBRA COIL 400 HCG, KRD KRD PENUMBRA, INC. F28862

    Patients

    Seq Age Sex Outcome Treatment
    1