BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2842885 · Received November 21, 2012

    Report

    Report Number
    3005168196-2012-00403
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO POSITION THE 9TH COIL, THE COIL WOULD NOT SIT WITH THE ANEURYSM AND BECAME STUCK. THE PHYSICIAN PULLED THE COIL BACK AND THE COIL UNINTENTIONALLY DETACHED. THE PET LOCK ON THE PROXIMAL END OF THE COIL WAS NOT SEPARATED. THE PHYSICIAN WAS THEN REQUIRED TO USE AN AMPLATZ GOOSENECK MICRO SNARE TIP, 4 MM LOOP SNARE. WHILE TRYING TO RECAPTURE THE COIL, THE PHYSICIAN MANAGED TO PUSH THE COIL INTO THE ANEURYSM AND AS THE PX400 MICROCATHETER WAS JAILED BEHIND THE LEO STENT, IT FACILITATED KEEPING THE COIL IN PLACE. PART OF THE COIL WAS LEFT IN THE ARTERY AND WILL ADHERE NICELY TO THE ARTERY WALL. NO ADVERSE EVENTS OR SIDE EFFECTS FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F19641

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention