BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12485417 · Received September 16, 2021

    Report

    Report Number
    3005168196-2021-02071
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 26, 2021
    Report Date
    October 18, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015767
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND IS BEING UPDATED ON THIS FOLLOW-UP # 01 MFR REPORT:3005168196-2021-02071 1. SECTION H. BOX 6. DEVICE CODE 2. EVALUATION OF THE RETURNED SMART COIL CONFIRMED THAT THE EMBOLIZATION COIL WAS NOT DETACHED, AND THE PULL WIRE WAS FRACTURED AT ITS PROXIMAL END. EVALUATION ALSO REVEALED THAT THE PUSHER ASSEMBLY BRAIDED SECTION WAS DAMAGED. THIS DAMAGE MAY HAVE CONTRIBUTED TO THE DIFFICULTY DETACHING IDENTIFIED IN THE REPORTED COMPLAINT. THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. FORCEFUL DETACHMENT ATTEMPTS LIKELY CONTRIBUTED TO THE PULL WIRE FRACTURE. THE DEVICE WAS UNABLE TO BE FUNCTIONALLY TESTED DUE TO THE PULL WIRE FRACTURE. FURTHER EVALUATION OF THE DEVICE REVEALED THAT THE PET LOCK WAS SEPARATED, THE PUSHER ASSEMBLY WAS KINKED, AND THE EMBOLIZATION COIL HAD OFFSET WIND. THE SEPARATED PET LOCK AND THE KINKED PUSHER ASSEMBLY WERE LIKELY DUE TO THE COIL DETACHMENT ATTEMPTS DURING THE PROCEDURE. THE OFFSET COIL WINDS WERE INCIDENTAL TO THE REPORTED COMPLAINT. PENUMBRA COILS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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 NUMBER: 1.3005168196-2021-02072 H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-02072.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT DETACH WITH THE HANDLE, AND THE SMART COIL BROKE ON THE PROXIMAL END. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378534 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT2H06 F103167 00814548015767

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR