BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 7131098 · Received December 19, 2017

    Report

    Report Number
    3005168196-2017-02250
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548014678
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2017-02247, 2. 3005168196-2017-02248, 3. 3005168196-2017-02249. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ASCENDING AORTA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE SMART COILS USING A NON-PENUMBRA MICROCATHETER, BUT ALSO FELT RESISTANCE ADVANCING FOUR SMART COILS OUT OF THE MICROCATHETER AND INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING DIFFICULTY SEEING WHEN THE SMART COILS EXITED THE MICROCATHETER, AND THEREFORE THE PHYSICIAN WAS UNSURE WHETHER THE RESISTANCE WAS CAUSED BY THE MICROCATHETER POSITIONING, A POSSIBLE KINK IN THE MICROCATHETER, OR WHETHER THE RESISTANCE WAS DUE TO THE SMART COILS. THE FOUR SMART COILS WERE THEREFORE RETRACTED, AND THE PROCEDURE WAS CONTINUED USING SHORTER SMART COILS. THE PROCEDURE WAS THEN COMPLETED USING A LANTERN DELIVERY MICROCATHETER AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909886 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F77656 00814548014678

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR