BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 9819375 · Received March 11, 2020

    Report

    Report Number
    3005168196-2020-00331
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 18, 2020
    Report Date
    February 20, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015705
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP MFR REPORT 3005168196-2020-00331: 1. SECTION B. BOX 4. DATE OF THIS REPORT. RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 51.0 CM FROM THE PROXIMAL END. THE EMBOLIZATION COIL WAS INTACT WITH THE PUSHER ASSEMBLY AND HAD OFFSET COIL WINDS ALONG ITS LENGTH. CONCLUSIONS: EVALUATION OF THE RETURNED SMART COIL REVEALED OFFSET COIL WINDS ON ITS EMBOLIZATION COIL. IF THE DEVICE IS FORCEFULLY ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS THE OFFSET COIL WINDS MAY OCCUR. THE NON-PENUMBRA MICROCATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. DURING THE FUNCTIONAL TESTING, THE SMART COIL WAS ABLE TO BE ADVANCED THOROUGH A DEMONSTRATION MICROCATHETER WITH RESISTANCE DUE TO THE PUSHER ASSEMBLY KINK. THE PUSHER ASSEMBLY KINK WAS LIKELY INCIDENTAL TO THE COMPLAINT AND MAY HAVE OCCURRED DURING ADVANCEMENT AGAINST RESISTANCE OR DURING PACKAGING FOR RETURN TO PENUMBRA. 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PARACLINOID OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL HALFWAY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND HAD DIFFICULTY ADVANCING THE SMART COIL FURTHER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280180 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0203 F81910 00814548015705

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR