BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4182972 · Received October 17, 2014

    Report

    Report Number
    3005168196-2014-00750
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE RUBY COIL IS DETACHED FROM THE PUSHER ASSEMBLY. THE PET-LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY, INDICATING THAT THE COIL WAS NOT DETACHED AS INTENDED. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 7.0 CM FROM THE PROXIMAL END. THE COIL STRETCH RESISTANT SR WIRE WAS FRACTURED AND THE COIL WAS UNWOUND AND SEVERELY DAMAGED. THE PROXIMAL CONSTRAINT SPHERE WAS INTACT WITH THE FRACTURED SR WIRE. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE RUBY COIL STARTED TO COME APART WHILE BEING RETRACTED INTO THE COIL INTRODUCER SHEATH. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THAT THE PENUMBRA RUBY COIL WAS DAMAGED. THE COIL SR WIRE WAS FRACTURED AND THE COIL WAS PULLED APART. THIS DAMAGE LIKELY OCCURRED DUE TO FORCE PLACED ON THE DEVICE IN EXCESS OF THE TENSILE STRENGTH OF THE SR WIRE DURING RETRACTION INTO THE COIL SHEATH. SUBSEQUENT DAMAGE TO THE COIL WAS LIKELY CAUSED BY HANDLING AS THE DEVICE CONTINUED TO BE MANIPULATED IN AN ATTEMPT TO RETRACT IT INTO THE COIL SHEATH. THE COIL INTRODUCER SHEATH WAS NOT RETURNED WITH THE DEVICE THEREFORE, EVALUATION OF THE SHEATH COULD NOT BE PERFORMED. THE KINK IN THE PUSHER ASSEMBLY WAS NOT DESCRIBED IN THE COMPLAINT AND WAS LIKELY CAUSED BY HANDLING WHEN PACKAGING THE DEVICE FOR RETURN. THE CAUSE OF THE RESISTANCE DURING RETRACTION INTO THE SHEATH COULD NOT BE DETERMINED BASED ON THE DESCRIPTION OF THE EVENT OR EVALUATION OF THE RETURNED DEVICE. THE RUBY COIL DEVICES ARE 100% FUNCTIONALLY TESTED AND VISUALLY INSPECTED FOR DAMAGE DURING IN-PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN WITHDREW A RUBY COIL FROM THE PATIENT AND WHILE RE-SHEATHING, THE RUBY COIL BEGAN TO STRETCH AND COME APART. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662057 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F44173

    Patients

    Seq Age Sex Outcome Treatment
    1