BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 6028469 · Received October 13, 2016

    Report

    Report Number
    3005168196-2016-01466
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016658
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE FIRST LANTERN DELIVERY MICROCATHETER (LANTERN) EVALUATED WAS OVALIZED APPROXIMATELY 133.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICES REVEALED BOTH LANTERNS WERE OVALIZED NEAR THEIR DISTAL ENDS. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO FORCEFUL GRIPPING OR OTHERWISE COMPRESSING THE LANTERN DURING INSERTION INTO A PARENT CATHETER. THE OVALIZATIONS FOUND ON THE DISTAL ENDS OF THE LANTERN LIKELY CONTRIBUTED TO THE RESISTANCE EXPERIENCED BY THE PHYSICIAN WHILE ATTEMPTING TO ADVANCE THE LANTERNS THROUGH THE NON-PENUMBRA CATHETER. FURTHER EVALUATION REVEALED THE SECOND LANTERN WAS KINKED. THIS DAMAGE MAY HAVE OCCURRED DUE TO FORCEFUL ADVANCEMENT OF THE LANTERN AGAINST RESISTANCE. THE NON-PENUMBRA 5F DIAGNOSTIC CATHETER MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. 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: 3005168196-2016-01467.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A LANTERN THROUGH A NON-PENUMBRA SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN WAS UNABLE TO ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW LANTERN THROUGH THE SAME NON-PENUMBRA SHEATH; HOWEVER, RESISTANCE WAS EXPERIENCED AGAIN AND THE LANTERN WAS UNABLE TO ADVANCE THROUGH THE SHEATH. THE PROCEDURE WAS THEREFORE COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678417 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F69205 00814548016658

    Patients

    Seq Age Sex Outcome Treatment
    1