BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12278302 · Received August 4, 2021

    Report

    Report Number
    3005168196-2021-01747
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 15, 2021
    Report Date
    November 17, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015712
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. EVALUATION OF THE FIRST RETURNED SMART COIL CONFIRMED, THAT THE EMBOLIZATION COIL WAS DETACHED. FURTHER EVALUATION REVEALED, THAT THE PUSHER ASSEMBLY WAS KINKED IN MULTIPLE LOCATIONS THROUGHOUT ITS LENGTH, THE PUSHER ASSEMBLY WAS FRACTURED, AND THE PULL WIRE WAS RETRACTED OUT OF THE DDT. IF THE SMART COIL IS FORCEFULLY MANIPULATED AGAINST RESISTANCE DURING USE, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. IF THE PUSHER ASSEMBLY BECOMES FRACTURED AND THE PULL WIRE IS RETRACTED OUT OF THE DDT, THE EMBOLIZATION COIL WILL DETACH FROM THE PUSHER ASSEMBLY. EVALUATION OF THE SECOND RETURNED SMART COIL COULD NOT CONFIRM, THE REPORTED PUSHER ASSEMBLY BEING KINKED AT THE STARTING POSITION. FURTHER EVALUATION REVEALED, THAT THE PUSHER ASSEMBLY WAS KINKED ON ITS PROXIMAL END. THE INTRODUCER SHEATH WAS NOT RETURNED. AND THE EMBOLIZATION COIL HAD OFFSET COIL WINDS. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT, AND THE ROOT CAUSE COULD NOT BE DETERMINED. DURING THE FUNCTIONAL TEST, RESISTANCE WAS ENCOUNTERED, WHILE ATTEMPTING TO LOAD A DEMONSTRATION INTRODUCER SHEATH ON THE PUSHER ASSEMBLY DUE TO A KINK, AND THE INTRODUCER SHEATH COULD NOT BE ADVANCED ANY FURTHER. THEREFORE, NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED. 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. SECTION H: BOX 6, CONCLUSIONS CODE 1: 4316: THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED KINK. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1. 3005168196-2021-01748. H3 OTHER TEXT: PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01748.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED COILS IN THE TARGET LOCATION. SUBSEQUENTLY, WHILE THE HOSPITAL TECH WAS ATTEMPTING TO ADVANCE A SMART COIL (F102548), THE PUSHER ASSEMBLY KINKED WHEN THE SMART COIL WAS AT THE STARTING POSITION OF THE INTRODUCER SHEATH. THE SMART COIL WAS THEN REMOVED. NEXT, WHILE THE PHYSICIAN WAS RETRACTING A SMART COIL (F81966) TO REPOSITION THE TIP OF THE MICROCATHETER, THE SMART COIL BROKE OFF BETWEEN THE LEFT ICA AND THE STENT. THE PHYSICIAN DECIDED TO HAVE THE SMART COIL REMAIN IN THE PATIENT AS THE SMART COIL WAS SECURED BETWEEN THE STENT AND VESSEL WALL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171823 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0204 F81966 00814548015712

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female