BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3910031 · Received July 2, 2014

    Report

    Report Number
    3005168196-2014-00437
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PUSHER ASSEMBLY IS KINKED APPROXIMATELY 5.0 CM, 38.0 CM, AND 98.0 CM FROM THE PROXIMAL END. THE COIL IS STILL ATTACHED TO ITS PUSHER ASSEMBLY. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLIANT INDICATES THAT ALL THREE COILS WERE KINKED IN THE PROXIMAL AREA OF THE PUSHER ASSEMBLY DURING THE PROCEDURE. EVALUATION OF THE RETURNED DEVICE CONFIRMED KINKS AND DAMAGE IN THE PROXIMAL ENDS OF THE PUSHER ASSEMBLIES. THIS DAMAGE APPEARS TO BE RELATED TO A PROCEDURAL ISSUE WITH FRICTION BETWEEN THE COIL PUSHER ASSEMBLIES AND THE MICROCATHETER. IT IS POSSIBLE THAT THE PATIENT HAD HIGHLY TORTUOUS VESSELS OR THAT THE ACCESS WAS DIFFICULT. IT APPEARS THERE WAS SOME RESISTANCE WHEN PUSHING THE COILS, RESULTING IN KINKS AND SUBSEQUENT DAMAGE, INCLUDING FRACTURES TO THE PUSHER ASSEMBLIES. THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED FROM THE RETURNED DEVICES OR THE DESCRIPTION OF THE COMPLAINT. THESE DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING PACKAGING. 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 3005168196-2014-00435, AND 00436.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN KINKED THE PUSHER WIRE AT THE PROXIMAL END WHILE INSERTING THE RUBY COIL INTO THE MICROCATHETER. THE PHYSICIAN REMOVED THE COILS IN FEAR OF UNINTENTIONAL DETACHMENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388164 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F40094

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR