BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 17406453 · Received July 27, 2023

    Report

    Report Number
    3005168196-2023-00355
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 26, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016641
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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:3005168196-2023-00355. 1. SECTION H. BOX 6. DEVICE CODE 1. EVALUATION OF THE RETURNED LANTERN CONFIRMED A FRACTURE AND REVEALED A KINK NEAR THE FRACTURE. THIS DAMAGE TYPICALLY OCCURS IF THE DEVICE IS ADVANCED AGAINST RESISTANCE DURING USE. IF THE LANTERN IS ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS KINKS AND A SUBSEQUENT FRACTURE MAY OCCUR. FURTHER EVALUATION REVEALED OVALIZATION ON THE CATHETER DISTAL END, AND THE DISTAL TIP WAS DEFORMED. THIS DAMAGE MAY HAVE ALSO OCCURRED DURING ADVANCEMENT. BASED ON THE REPORTED EVENT, THE ROOT CAUSE OF RESISTANCE 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN OVER THE GUIDEWIRE TO THE TARGET LOCATION, THE LANTERN FRACTURED AT THE PROXIMAL LOCATION. THEREFORE, THE LANTERN WAS REMOVED IN ITS ENTIRETY. 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
    1258258 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F106868 00814548016641

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male