BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 11359890 · Received February 22, 2021

    Report

    Report Number
    3005168196-2021-00314
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 22, 2021
    Report Date
    January 25, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015101
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE PUSHER ASSEMBLY MID-JOINT WAS RETRACTED PROXIMAL TO THE INTRODUCER SHEATH FRICTION LOCK. IF THIS OCCURS, RESISTANCE WILL LIKELY BE EXPERIENCED DURING ADVANCEMENT AND THE DEVICE MAY NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH. DURING FUNCTIONAL TESTING, THE PUSHER ASSEMBLY MID-JOINT WAS ADVANCED THROUGH THE INTRODUCER SHEATH FRICTION LOCK WITH RESISTANCE. THEN THE SMART COIL WAS ABLE TO ADVANCE THROUGH THE INTRODUCER SHEATH WITHOUT ISSUE. FURTHER EVALUATION OF THE DEVICE REVEALED A PUSHER ASSEMBLY KINK. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT AND MAY HAVE OCCURRED DURING PACKAGING FOR RETURN TO PENUMBRA. EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE PUSHER ASSEMBLY WAS KINKED, AND THE EMBOLIZATION COIL HAD OFFSET COIL WINDS. IF THE DEVICE IS FORCEFULLY ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. THE ROOT CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. DURING FUNCTIONAL TESTING, THE SMART COIL WAS ABLE TO ADVANCE THROUGH THE INTRODUCER SHEATH WITHOUT ISSUE. EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE PUSHER ASSEMBLY MID-JOINT WAS RETRACTED PROXIMAL TO THE INTRODUCER SHEATH FRICTION LOCK. IF THIS OCCURS, RESISTANCE WILL LIKELY BE EXPERIENCED DURING ADVANCEMENT AND THE DEVICE MAY NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH. FORCEFUL ADVANCEMENT AGAINST THIS RESISTANCE MAY HAVE CONTRIBUTED TO THE KINKS AND FRACTURE WHICH WERE OBSERVED NEAR THE PUSHER ASSEMBLY MID-JOINT. FURTHER EVALUATION OF THE DEVICE REVEALED AN ADDITIONAL PUSHER ASSEMBLY KINK. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT AND MAY HAVE OCCURRED DURING PACKAGING FOR RETURN TO PENUMBRA. 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2021-00315. 2. 3005168196-2021-00316.

    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: 3005168196-2021-00315, 3005168196-2021-00316.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A NEURO FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE THREE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART 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
    259724 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTSFT0510 F98291 00814548015101

    Patients

    Seq Age Sex Outcome Treatment
    1