BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 5514119 · Received March 21, 2016

    Report

    Report Number
    3005168196-2016-00340
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013244
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 1. 3005168196-2016-00339, 2. 3005168196-2016-00341, THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE THE RUBY COIL WAS BEING ADVANCED THROUGH THE LANTERN, IT BROKE INSIDE THE LANTERN AND WAS REMOVED USING A SYRINGE. THE PHYSICIAN CONTINUED THE PROCEDURE BY DEPLOYING AND DETACHING SEVEN NEW RUBY COILS INTO THE ANEURYSM USING THE LANTERN. AFTER THE SEVENTH RUBY COIL WAS DEPLOYED, THE LANTERN STARTED TO FEEL "GRITTY"; THEREFORE, THE PHYSICIAN REPLACED THE LANTERN WITH A NEW LANTERN AND CONTINUED TO DEPLOY TWO ADDITIONAL RUBY COILS INTO THE ANEURYSM. WHILE THE PHYSICIAN WAS ADVANCING THE LAST RUBY COIL THROUGH THE LANTERN, IT BROKE PARTIALLY OUT OF THE LANTERN AND WAS REMOVED USING A SYRINGE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169765 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F64000 00814548013244

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR