BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4103520 · Received September 19, 2014

    Report

    Report Number
    3005168196-2014-00652
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 22, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE RUBY COIL WAS DETACHED FROM THE PUSHER ASSEMBLY. THE PROXIMAL CONSTRAINT BALL WAS IN THE DISTAL DETACHMENT TIP (DDT) WITH A BROKEN PIECE OF THE STRETCH RESISTANT (SR) WIRE. THE COIL ALSO HAS A BROKEN PIECE OF SR-WIRE EXPOSED. THE COIL PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 5.0, 21.5, 56.0, AND 89.0 CM FROM THE PROXIMAL END. THE PET-LOCK WAS INTACT, INDICATING THAT THE COIL WAS NOT DETACHED AS INTENDED. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE RUBY COIL UNINTENTIONALLY DETACHED WHEN PARTIALLY INSIDE THE MICROCATHETER. EVALUATION OF THE RETURNED DEVICE CONFIRMED UNINTENTIONAL DETACHMENT OF THE COIL AS EVIDENCED BY THE INTACT PROXIMAL PET-LOCK ON THE PUSHER ASSEMBLY AND BROKEN SR WIRE. IT APPEARS THAT THE TORTUOUS ANATOMY DESCRIBED IN THE COMPLAINT LED TO RESISTANCE WHEN DEPLOYING THE COIL, CAUSING FORCE IN EXCESS OF THE TENSILE STRENGTH OF THE SR WIRE TO BE PLACED ON THE COIL. THIS FORCE CAUSED A BREAK IN THE SR WIRE AND COIL DETACHMENT. THE KINKS IN THE PUSHER ASSEMBLY ALSO INDICATE THAT FORCE WAS PLACED ON THE DEVICE DURING COIL DEPLOYMENT AGAINST RESISTANCE. THE COILS ARE 100% FUNCTIONALLY TESTED DURING PROCESSING. 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 RUBY COILS. THE PHYSICIAN PARTIALLY DEPLOYED A RUBY COIL WHEN IT BECAME UNINTENTIONALLY DETACHED. THE PHYSICIAN REMOVED THE RUBY COIL SUCCESSFULLY AND THE CASE CONTINUED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583857 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F40313

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR