BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 8826500 · Received July 25, 2019

    Report

    Report Number
    3005168196-2019-01428
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 25, 2019
    Report Date
    June 25, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016641
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE LANTERN DELIVERY MICROCATHETER (LANTERN) WAS UNDAMAGED. AN UNKNOWN SUBSTANCE WAS WITHIN THE LANTERN APPROXIMATELY 5.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED LANTERN REVEALED AN UNKNOWN SUBSTANCE WITHIN THE PROXIMAL END OF THE LANTERN. IF THE LANTERN IS OCCLUDED, RESISTANCE MAY BE EXPERIENCED WHILE ADVANCING A DEVICE THROUGH THE CATHETER. DURING FUNCTIONAL TESTING, A DEMONSTRATION RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE LANTERN. THE UNKNOWN SUBSTANCE LIKELY CONTRIBUTED TO THE INABILITY TO ADVANCE THE RUBY COIL DURING THE PROCEDURE AND DURING FUNCTIONAL TESTING. THE ROOT CAUSE OF THE UNKNOWN SUBSTANCE COULD NOT BE DETERMINED. 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2019-01429, 2. 3005168196-2019-01430, 3. 3005168196-2019-01431, 4. 3005168196-2019-01432. H3 OTHER TEXT : PLACEHOLDER.

    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: 3005168196-2019-01429, 3005168196-2019-01430, 3005168196-2019-01431, 3005168196-2019-01432.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A EMBOLIZATION PROCEDURE IN THE POPLITEAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN MADE A DIRECT STICK INTO THE PATIENT'S ANATOMY, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, WHILE ADVANCING THE RUBY COIL, IT BECAME STUCK WITHIN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE NON-PENUMBRA MICROCATHETER WAS THEN RE-POSITIONED AND THE PHYSICIAN ATTEMPTED AGAIN TO ADVANCE THE SAME RUBY COIL; HOWEVER, THE COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS THEN REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL WITH THE SAME NON-PENUMBRA MICROCATHETER, BUT SAME ISSUE OCCURRED; THEREFORE, THE COIL WAS REMOVED. THE PHYSICIAN RE-POSITIONED THE NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO ADVANCE A THIRD RUBY COIL; HOWEVER, IT BECAME STUCK IN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE NON-PENUMBRA MICROCATHETER AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND SUCCESSFULLY PLACED 15 RUBY COILS WITHOUT AN ISSUE. HOWEVER, WHILE ADVANCING THE 16TH AND FINAL RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL BECAME STUCK APPROXIMATELY THREE INCHES INTO THE PROXIMAL PORTION OF THE LANTERN; THE RUBY COIL WAS THEN RETRACTED SEVERAL TIMES, BUT IT WOULD NOT ADVANCE PAST THE RESISTANCE IN THE LANTERN; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS ENDED AFTER REMOVAL OF THE FINAL RUBY COIL AS THE PHYSICIAN WAS SATISFIED WITH THE RESULT OBTAINED WITH THE OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622330 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F82279 00814548016641

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR