BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL DETACHMENT HANDLE

    MDR report key: 9769789 · Received February 28, 2020

    Report

    Report Number
    3005168196-2020-00244
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 1, 2020
    Report Date
    February 3, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016139
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THERE WERE NO VISIBLE DAMAGE ON THE RETURNED HANDLES. CONCLUSIONS: EVALUATION OF THE TWO RETURNED HANDLES CONFIRMED THAT BOTH DEVICES WERE FUNCTIONAL. BOTH HANDLES WERE FUNCTIONALLY TESTED ON THE HANDLE FIXTURE AND PASSED WITHIN SPECIFICATION. EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE PUSHER ASSEMBLY WAS KINKED IN MULTIPLE LOCATIONS ALONG ITS LENGTH. IF THE PUSHER ASSEMBLY IS FORCEFULLY MISHANDLED DURING USE, DAMAGE SUCH AS KINKS MAY OCCUR. IF THE PUSHER ASSEMBLY IS KINKED, THE PULL WIRE MAY BECOME PINNED WITHIN THE HYPOTUBE AND RESISTANCE MAY BE EXPERIENCED DURING ATTEMPTS TO DETACH THE EMBOLIZATION COIL IS MADE USING A DETACHMENT HANDLE OR MANUAL DETACHMENT. DURING THE FUNCTIONAL TEST, THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS FRACTURED BY THE PENUMBRA INVESTIGATOR IN ORDER TO LOCATE THE PULL WIRE. THE PULL WIRE WAS MANUALLY RETRACTED BY THE INVESTIGATOR AND FRACTURED DUE TO THE RESISTANCE AND THE SMART COIL DID NOT DETACH FROM ITS PUSHER ASSEMBLY. FURTHER EVALUATION OF THE RETURNED SMART COIL REVEALED OFFSET COIL WINDS. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT. PENUMBRA COILS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. PENUMBRA HANDLES ARE VISUALLY INSPECTED AND 100% FUNCTIONALLY TESTED DURING INCOMING INSPECTION BY QUALITY. 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 NUMBERS: 1. 3005168196-2020-00241, 2. 3005168196-2020-00242, 3. 3005168196-2020-00243.

    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 NUMBERS: 1. 3005168196-2020-00241, 2. 3005168196-2020-00242, 3. 3005168196-2020-00243.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), NON-PENUMBRA COILS, NON-PENUMBRA GUIDING SHEATH AND, NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE GUIDING SHEATH INTO THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND PLACED TWELVE COILS IN THE ACA USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH TWICE AND, THEREFORE, THE HANDLE WAS REMOVED, AND A NEW HANDLE WAS USED TO DETACH THE SAME SMART COIL. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN MANUALLY PULLED THE PULL WIRE OF THE SMART COIL PUSHER ASSEMBLY; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234853 PENUMBRA SMART COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. SCH1 F90396 00814548016139

    Patients

    Seq Age Sex Outcome Treatment
    1