BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 9633867 · Received January 27, 2020

    Report

    Report Number
    3005168196-2020-00092
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 2, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548010922
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE PET LOCK WAS BROKEN ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE EMBOLIZATION COIL WAS UNDAMAGED AND INTACT WITH THE PUSHER ASSEMBLY. THE EMBOLIZATION COIL WAS ADVANCED DISTAL TO THE INTRODUCER SHEATH AND THE PUSHER ASSEMBLY WAS STUCK INSIDE THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS STRETCHED ALONG ITS LENGTH. CONCLUSIONS: EVALUATION OF THE RETURNED POD PC CONFIRMED THE REPORTED SHEATH DAMAGE. THE RETURNED INTRODUCER SHEATH WAS STRETCHED, AND PUSHER ASSEMBLY WAS STUCK IN THE INTRODUCER SHEATH. DURING FUNCTIONAL TESTING, THE DAMAGED INTRODUCER SHEATH WAS REMOVED. THEN THE POD PC PUSHER ASSEMBLY WAS RE-SHEATHED WITH A DEMONSTRATION INTRODUCER SHEATH WITHOUT ISSUE. THE ROOT CAUSE OF THE DAMAGED INTRODUCER SHEATH WAS UNABLE TO BE DETERMINED. FURTHER INVESTIGATION REVEALED OFFSET COIL WINDS. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT. EVALUATION OF THE RETURNED PC400 WAS UNABLE TO CONFIRM A STRETCHED PUSHER ASSEMBLY. THE INTRODUCER SHEATH WAS STRETCHED, AND THE PUSHER ASSEMBLY WAS STUCK INSIDE THE INTRODUCER SHEATH. IF THE INTRODUCER SHEATH IS RETRACTED AGAINST RESISTANCE, IT MAY BECOME STRETCHED. BASED ON THE RETURNED CONDITION, THE FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED; THEREFORE, THE ROOT CAUSE OF THE RESISTANCE WAS UNABLE TO BE DETERMINED. 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 NUMBER: 3005168196-2020-00091.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2020-00091.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SIGMOID SINUS USING PENUMBRA COILS 400 (PC400S), POD PACKING COILS (POD PCS), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN ATTEMPTED TO REMOVE THE INTRODUCER SHEATH OF THE PC400, BUT THE PUSHER ASSEMBLY OF THE PC400 STRETCHED; THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE AND PLACED ANOTHER PC400 INTO THE TARGET VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE THE POD PC THROUGH THE PX SLIM INTO THE TARGET VESSEL, THE PUSHER ASSEMBLY OF THE POD PC APPEARED KINKED AND ITS INTRODUCER SHEATH ¿CRIMPED"; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PC AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96506 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. 4004C0820 F84467 00814548010922

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR