BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 9628971 · Received January 24, 2020

    Report

    Report Number
    3005168196-2020-00097
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 3, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016689
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE LANTERN WAS UNDAMAGED. CONCLUSIONS: EVALUATION OF THE RETURNED LANTERN REVEALED A FULLY FUNCTIONAL DEVICE. A DEMONSTRATION COIL WAS ABLE TO ADVANCE THROUGH THE LANTERN WITHOUT ISSUE. EVALUATION OF THE RETURNED RUBY COIL REVEALED OFFSET COIL WINDS ALONG THE LENGTH OF THE EMBOLIZATION COIL. THE EMBOLIZATION COILS WERE COMPRESSED DISTALLY. THE PROXIMAL CONSTRAINT SPHERE WAS ATTACHED TO THE PUSHER ASSEMBLY. IF THE DEVICE IS FORCEFULLY ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS OFFSET COIL WINDS MAY OCCUR. IF DAMAGED COIL WINDS ARE RETRACTED AGAINST RESISTANCE, THEY MAY BEGIN TO COMPRESS AND CAUSE ADDITIONAL DAMAGE. ROOT CAUSE OF THE INITIAL RESISTANCE DURING THE CASE COULD NOT BE DETERMINED. PENUMBRA CATHETERS AND COILS 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. 3005168196-2020-00094 2. 3005168196-2020-00095 3. 3005168196-2020-00096.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DIAGNOSTIC CATHETER AND THE LANTERN IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO ADDITIONAL RUBY COILS THROUGH THE LANTERN, HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN THEN REMOVED THE DIAGNOSTIC CATHETER AND LANTERN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90805 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. PXSLIMLAN150T45 F90937 00814548016689

    Patients

    Seq Age Sex Outcome Treatment
    1