BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 9371279 · Received November 25, 2019

    Report

    Report Number
    3005168196-2019-02186
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 18, 2019
    Report Date
    October 29, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016658
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2019-02186 1. SECTION H. BOX 6. PATIENT CODE 2 RESULTS: THE RETURNED LANTERN WAS KINKED AT APPROXIMATELY 50.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED LANTERN REVEALED A KINK. IF THE LANTERN IS FORCEFULLY ADVANCED THROUGH THE REPORTED PATIENT¿S TORTUOUS ANATOMY, DAMAGE SUCH AS A KINK MAY OCCUR. THIS KINK LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE EXPERIENCED WHILE ADVANCING THE POD8 THROUGH THE LANTERN. DURING FUNCTIONAL TESTING, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A TEST MANDREL INTO THE RETURNED LANTERN DUE TO THE KINK AND THE MANDREL COULD NOT ADVANCE ANY FURTHER. PENUMBRA 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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE FOLLOW UP #01 MFR REPORT::3005168196-2019-02186 AND ARE BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT:3005168196-2019-02186 1. SECTION H. BOX 2. IF FOLLOW-UP, WHAT TYPE? 2. SECTION H. BOX 10./11. ADDITIONAL NARRATIVE AND/OR CORRECTIVE DATA CORRECTED H10: PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2019-02186 1. SECTION H. BOX 6. DEVICE CODE 2 RESULTS: THE RETURNED LANTERN WAS KINKED AT APPROXIMATELY 50.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED LANTERN REVEALED A KINK. IF THE LANTERN IS FORCEFULLY ADVANCED THROUGH THE REPORTED PATIENT¿S TORTUOUS ANATOMY, DAMAGE SUCH AS A KINK MAY OCCUR. THIS KINK LIKELY CONTRIBUTED TO THE REPORTED RESISTANCE EXPERIENCED WHILE ADVANCING THE POD8 THROUGH THE LANTERN. DURING FUNCTIONAL TESTING, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A TEST MANDREL INTO THE RETURNED LANTERN DUE TO THE KINK AND THE MANDREL COULD NOT ADVANCE ANY FURTHER. PENUMBRA 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT HAD CALCIFIED PLAQUES AND TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD8 THROUGH THE LANTERN. IT WAS REPORTED THAT THE POD8 BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, THE POD8 AND LANTERN WERE REMOVED FROM THE PATIENT. THE PHYSICIAN PROCEEDED TO ADVANCE A NEW LANTERN INTO THE TARGET VESSEL AND SUBSEQUENTLY IMPLANTED THE SAME POD8 SUCCESSFULLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166484 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. PXSLIMLAN135T45 F87533 00814548016658

    Patients

    Seq Age Sex Outcome Treatment
    1