BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 17378789 · Received July 24, 2023

    Report

    Report Number
    3005168196-2023-00342
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 16, 2023
    Report Date
    August 19, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016696
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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:3 005168196-2023-00342 1. SECTION H. BOX 1. DEVICE CODE 1. EVALUATION OF THE RETURNED LANTERN CONFIRMED THAT THE CATHETER WAS FRACTURED. THIS TYPE OF DAMAGE TYPICALLY OCCURS IF DEVICE IS ADVANCED AGAINST RESISTANCE AND BECOME KINK AND SUBSEQUENT FRACTURE. BASED ON THE REPORTED COMPLAINT, THERE WAS NO MENTION OF RESISTANCE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED AN ADDITIONAL FRACTURE ON THE CATHETER SHAFT. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT AND MAY HAVE ALSO OCCURRED DURING THE PROCEDURE. 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

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. H3 OTHER TEXT: PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INTRODUCING THE LANTERN TO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE LANTERN AT THE MID-SHAFT. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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
    1370083 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F00001900 00814548016696

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male