BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 15217695 · Received August 12, 2022

    Report

    Report Number
    3005168196-2022-00376
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 25, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015651
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND ARE BEING INCLUDED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2022-00376. 1. SECTION H. BOX 6. RESULTS CODE. 2. SECTION H. BOX 6. CONCLUSIONS CODE. PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2022-00376. 1. SECTION H. BOX 10./11. NARRATIVE/CORRECTED DATA. THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED SMART COIL CONFIRMED THAT THE EMBOLIZATION COIL WAS DETACHED. EVALUATION REVEALED THAT THE PET LOCK WAS SEPARATED, AND THE PULL WIRE WAS RETRACTED OUT OF THE DDT. THIS INDICATES A SUCCESSFUL DETACHMENT ATTEMPT, AND THE EMBOLIZATION COIL WAS DETACHED AS INTENDED. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED THAT THE PUSHER ASSEMBLY WAS KINKED THROUGHOUT ITS LENGTH AND THE EMBOLIZATION COIL HAD OFFSET COIL WINDS THROUGHOUT ITS LENGTH. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT. PENUMBRA COILS ARE VISUALLY 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS AND ONE SMART COIL USING THE HANDLE. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN USED THE HANDLE TO DETACH THE SMART COIL; HOWEVER, THE COIL DID NOT DETACH. WHILE REMOVING THE SMART COIL, THE DISTAL END OF THE COIL WAS IN THE MIDDLE OF THE MICROCATHETER WHEN IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED FROM THE PATIENT AND THE SMART COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE HANDLE WAS NO LONGER REQUIRED AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL, THE SAME MICROCATHETER, THE SAME SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905863 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F107979 00814548015651

    Patients

    Seq Age Sex Outcome Treatment
    1 Male