BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 6874470 · Received September 18, 2017

    Report

    Report Number
    3005168196-2017-01580
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    August 22, 2017
    Report Date
    August 24, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015613
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE EMBOLIZATION COIL OF THE PENUMBRA SMART COIL (SMART COIL) WAS INTACT WITH THE PUSHER ASSEMBLY. THERE WAS NO VISIBLE DAMAGE TO EITHER SMART COIL. THE OUTER DIAMETERS (ODS) OF BOTH EMBOLIZATION COILS WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. DURING FUNCTIONAL ANALYSIS, THE SMART COILS COULD BE ADVANCED OUT OF THEIR INTRODUCER SHEATHS WITHOUT ISSUE. HOWEVER, WHEN ATTEMPTING TO ADVANCE THE SMART COILS INTO A DEMONSTRATION MICROCATHETER, EXTREME RESISTANCE WAS EXPERIENCED, AND THE EMBOLIZATION COILS COULD NOT BE FULLY ADVANCED INTO THE MICROCATHETER LUMEN. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED THAT BOTH SMART COILS COULD NOT BE ADVANCED INTO A DEMONSTRATION MICROCATHETER. EXTREME RESISTANCE WAS EXPERIENCED PRIOR TO ADVANCING EACH EMBOLIZATION COIL ENTIRELY INTO THE MICROCATHETER LUMEN. THIS RESISTANCE LIKELY OCCURRED DUE TO THE EMBOLIZATION COIL TAKING SHAPE WITHIN THE LUMEN OF THE MICROCATHETER. THE ROOT CAUSE OF THE EMBOLIZATION COIL TAKING SHAPE PRIOR TO ADVANCING OUT OF THE MICROCATHETER COULD NOT BE DETERMINED. THE NON-PENUMBRA MICROCATHETER MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. PENUMBRA COILS ARE 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2017-001581.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL SMART COIL INTO THE PATIENT USING A NON-PENUMBRA GUIDING SHEATH AND A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ADVANCED THE SMART COIL A FEW CENTIMETERS INTO THE HUB OF THE MICROCATHETER AND THEN ENCOUNTERED RESISTANCE. SUBSEQUENTLY THE SMART COIL BECAME STUCK AND WAS UNABLE TO ADVANCE COMPLETELY INTO THE MICROCATHETER. THE SMART COIL WAS THEN REMOVED AND SOAKED IN SALINE. NEXT, THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE SMART COIL INTO THE MICROCATHETER BUT THE COIL WOULD NOT ADVANCE AT ALL AND WAS REMOVED. THEREAFTER, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED AND THE COIL WAS UNABLE TO ADVANCE COMPLETELY INTO THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL 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
    652761 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F72560 00814548015613

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR