BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4182276 · Received October 17, 2014

    Report

    Report Number
    3005168196-2014-00727
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULT: THE RUBY COIL AND PET-LOCK WERE INTACT WITH THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 130.5 CM FROM THE PROXIMAL END. THE COIL WAS KINKED ALONG THE ENTIRE LENGTH. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE RUBY COIL AND PX SLIM DELIVERY MICROCATHETER WERE KINKED UNINTENTIONALLY DURING USE. EVALUATION OF THE RETURNED PRODUCTS CONFIRMED THAT THE RUBY COIL AND PX SLIM DELIVERY MICROCATHETER WERE DAMAGED. IT APPEARS THAT THE PX SLIM DELIVERY MICROCATHETER WAS DAMAGED DURING PREPARATION. UPON LOADING THE RUBY COIL INTO THE PX SLIM DELIVERY MICROCATHETER, THE FORCE USED TO ADVANCE THE COIL DISTALLY RESULTED IN A KINK IN THE PUSHER ASSEMBLY. THE ROOT CAUSE OF THIS COMPLAINT COULD HAVE BEEN A USER ERROR. THESE DEVICES ARE 100% FUNCTIONAL TEST AND VISUALLY INSPECTED FOR DAMAGE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00728.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL AND A PX SLIM DELIVERY MICROCATHETER. DURING THE PROCEDURE, BOTH THE RUBY COIL AND THE PX SLIM DELIVERY MICROCATHETER BECAME KINKED. BOTH DEVICES WERE REMOVED AND THE PROCEDURE CONTINUED USING NEW DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661993 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F43023

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR