BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 13675842 · Received March 4, 2022

    Report

    Report Number
    3005168196-2022-00103
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 4, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548017051
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NUMBER: 3005168196-2022-00102.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL (F109435) AS THE FIRST COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN THEN PULLED BACK ON THE MICROCATHETER AND ATTEMPTED AGAIN TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE COIL STILL WOULD NOT DETACH. SUBSEQUENTLY, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE, AND THE SMART COIL ALSO FAILED TO DETACH USING A SECOND HANDLE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL FROM THE MICROCATHETER. WHILE RETRACTING THE SMART COIL FROM THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN DECIDED TO LEAVE THE SMART COIL IN PLACE SINCE MOST OF THE SMART COIL WAS IN THE ANEURYSM AND ONLY THE TAIL OF THE COIL REMAINED OUTSIDE OF THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL (F102575) TO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE SECOND HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. WHILE RETRACTING THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED, AND A NEW NON-PENUMBRA MICROCATHETER WAS ADVANCED INTO THE ANEURYSM. THEN, THE PHYSICIAN ADVANCED ANOTHER SMART COIL (F100967) TO THE ANEURYSM USING THE SECOND MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SECOND HANDLE; HOWEVER, THE COIL FAILED TO DETACH. SUBSEQUENTLY, THE SECOND HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE, AND THE SMART COIL ALSO FAILED TO DETACH USING A THIRD HANDLE. THEREFORE, THE SMART COIL WAS REMOVED WITHOUT ISSUE. THE SAME ISSUE OCCURRED WHILE ATTEMPTING TO DETACH ONE ADDITIONAL SMART COIL (F106748) IN THE ANEURYSM USING THE THIRD HANDLE. THEREFORE, THE SMART COIL WAS ALSO REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532326 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTSFT4H10 F102575 00814548017051

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown