BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANTERN DELIVERY MICROCATHETER

    MDR report key: 6077082 · Received November 3, 2016

    Report

    Report Number
    3005168196-2016-01554
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016627
    PMA / PMN Number
    K152840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. 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: 3005168196-2016-01553, 3005168196-2016-01555, 3005168196-2016-01556, 3005168196-2016-01557. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A FALSE LUMEN OF THE AORTA USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL (LOT #F70605 OR LOT #F70060) THROUGH A LANTERN (LOT #F70196 OR LOT #F69066), THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE TIP OF THE LANTERN. SUBSEQUENTLY, THE COIL BECAME STUCK AND UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. UPON REMOVAL OF THE LANTERN, THE PHYSICIAN NOTICED THAT THE TIP WAS KINKED. A NEW LANTERN (LOT #F70196 OR LOT #F69066) AND A NEW RUBY COIL (LOT #F70605 OR LOT #F70060) WERE THEN OPENED FOR THE PROCEDURE. HOWEVER, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE TIP OF THE LANTERN AGAIN. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK AND UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE LANTERN WAS ALSO KINKED. THE PHYSICIAN STATED THAT THERE WAS SOME CLOT INSIDE THE PATIENT THAT WAS CAUSING SOME CHALLENGES FOR THE COILS TO BE DEPLOYED. AT ANOTHER TIME IN THE PROCEDURE, WHILE ATTEMPTING TO INSERT A RUBY COIL (LOT #F67054) INTO THE HUB OF ONE OF THE LANTERN'S, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH. THEREFORE, THIS RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, SIXTEEN NEW RUBY COILS AND THE SAME NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT IT WAS NOT DOCUMENTED WHICH COILS WERE USED WITH WHICH LANTERN DEVICE. ADDITIONALLY, THE PHYSICIAN DID NOT MAINTAIN A CONTINUOUS FLUSH THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) BUT DID FLUSH THE LANTERN WITH A SYRINGE IN BETWEEN EACH COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726201 LANTERN DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F70196 00814548016627

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR