BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 15331863 · Received August 31, 2022

    Report

    Report Number
    3005168196-2022-00403
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 1, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015385
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    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:3005168196-2022-00403 1. SECTION H. BOX 6. IF IMPLANTED, GIVE DATE PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2022-00403 1. SECTION H. BOX 3.''OTHER'' REASON FOR NON-EVALUATION 2. SECTION H. BOX 6. METHOD CODE 2 H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE ANEURYSM WAS PARTIALLY COILED PREVIOUSLY WITH THE SMART COILS AND A STENT WAS PLACED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE MULTIPLE TIMES. HOWEVER, THE SMART COIL FAILED TO DETACH. NEXT, THE PHYSICIAN TRIED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL WOULD NOT DETACH. WHILE ATTEMPTING TO REMOVE THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE TARGET LOCATION. THE PHYSICIAN THEN USED A GUIDEWIRE TO PUSH THE REMAINING SMART COIL IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, IT WAS UNSUCCESSFUL. THE SECOND HANDLE WAS OPENED, AND THREE ATTEMPTS WERE MADE TO DETACH THE SMART COIL BUT THE SMART COIL WOULD NOT DETACH. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL AND THE COIL WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE ENDED AT THIS POINT AND NO ADDITIONAL COILS WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405450 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F105466 00814548015385

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male