BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 8744760 · Received June 28, 2019

    Report

    Report Number
    3005168196-2019-01275
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 30, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548010649
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED AT APPROXIMATELY 5.0 CM FROM THE PROXIMAL END. THE EMBOLIZATION COIL WAS INTACT WITH THE PUSHER ASSEMBLY AND HAD OFFSET COIL WINDS. THE PUSHER ASSEMBLY WAS RETRACTED PROXIMAL TO THE INTRODUCER SHEATH AND THE EMBOLIZATION COIL WAS COMPRESSED WITHIN THE INTRODUCER SHEATH. CONCLUSIONS: EVALUATION OF THE RETURNED LANTERN REVEALED AN OVALIZATION NEAR ITS DISTAL TIP. IF THE DEVICE IS FORCEFULLY GRIPPED OR PINCHED DURING PREPARATION, DAMAGE SUCH AS OVALIZATION MAY OCCUR. A DEMONSTRATION PC400 WAS ATTEMPTED TO ADVANCE THROUGH THE RETURNED LANTERN DURING THE FUNCTIONAL TESTING AND RESISTANCE WAS ENCOUNTERED AT THE OVALIZATION ON THE LANTERN. THE EMBOLIZATION COIL COULD NOT ADVANCE PAST THE OVALIZATION. EVALUATION OF THE PC400 REVEALED A KINKED PUSHER ASSEMBLY AND AN EMBOLIZATION COIL WITH OFFSET COIL WINDS. IF THE PC400 IS FORCEFULLY ADVANCED AGAINST RESISTANCE, DAMAGES SUCH AS THESE MAY OCCUR. DURING FUNCTIONAL TESTING, THE PC400 WAS UNABLE TO ADVANCE THROUGH ITS INTRODUCER SHEATH. THE OFFSET COIL WINDS LIKELY CONTRIBUTED TO THE DIFFICULTY ADVANCING THE DEVICE DURING FUNCTIONAL TESTING. THE LANTERN USED IN THE PROCEDURE WAS RETURNED FOR EVALUATION AND WAS OVALIZED NEAR ITS DISTAL TIP. THIS OVALIZATION LIKELY CAUSED THE REPORTED RESISTANCE DURING THE PROCEDURE. EVALUATION OF THE PC400 REVEALED OFFSET COIL WINDS ON THE EMBOLIZATION COIL. IF THE PC400 IS FORCEFULLY ADVANCED AGAINST RESISTANCE, DAMAGES SUCH AS OFFSET COIL WINDS MAY OCCUR. DURING FUNCTIONAL TESTING, THE PC400 WAS UNABLE TO ADVANCE THROUGH ITS INTRODUCER SHEATH. THE OFFSET COIL WINDS LIKELY CONTRIBUTED TO THE DIFFICULTY ADVANCING THE DEVICE DURING FUNCTIONAL TESTING. THE LANTERN USED IN THE PROCEDURE WAS RETURNED FOR EVALUATION AND WAS OVALIZED NEAR ITS DISTAL TIP. THIS OVALIZATION LIKELY CAUSED THE REPORTED RESISTANCE DURING THE PROCEDURE. PENUMBRA COILS AND CATHETERS 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 NUMBERS: 1.3005168196-2019-01274 2.3005168196-2019-01276.

    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 NUMBERS: 3005168196-2019-01274, 3005168196-2019-01276.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A 45-DEGREE TIP LANTERN IN THE TARGET LOCATION AND ATTEMPTED TO ADVANCE TWO PC400S THROUGH IT. HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING EACH COIL THROUGH THE ANGLED DISTAL TIP OF THE LANTERN. THE PHYSICIAN THEN REMOVED THE PC400S AND LANTERN AND INSERTED A NEW LANTERN WITH A STRAIGHT TIP. UPON REMOVAL OF THE PC400S AND THE LANTERN IT WAS NOTED THAT THE PC400S HAD THE OFFSET COIL WINDS AND THE TIP OF THE LANTERN HAD STRETCHED AND NARROWED. THE PROCEDURE WAS THEN COMPLETED USING THE NEW LANTERN, RUBY COILS, AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536891 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F80386 00814548010649

    Patients

    Seq Age Sex Outcome Treatment
    1