BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL DETACHMENT HANDLE

    MDR report key: 4101906 · Received September 19, 2014

    Report

    Report Number
    3005168196-2014-00655
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THERE WAS NO DAMAGE TO THE RUBY COIL DETACHMENT HANDLE OR PUSHER WIRE INSIDE. THE RUBY COIL DETACHMENT HANDLE WAS TESTED USING THE PRODUCTION TEST FIXTURE WHICH MEASURES THE THROW DISTANCE AND PULL FORCE. THE DETACHMENT HANDLE ACTUATED CORRECTLY AND PASSED FOR BOTH THROW DISTANCE AND PULL FORCE. THE HANDLE IS FUNCTIONAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT A GREAT DEAL OF RESISTANCE WAS FELT WHEN THE COIL WAS EXITING THE MICROCATHETER. THE COMPLAINT ALSO STATES THAT DURING THE DETACHMENT OF ANOTHER COIL A PIECE OF THE PUSHER WIRE CAME LOOSE IN THE DETACHMENT HANDLE. EVALUATION OF THE RETURNED PRODUCT REVEALED THAT THE COIL WAS LODGED INSIDE THE INTRODUCER SHEATH. THE INTRODUCER SHEATH DID NOT HAVE ANY DAMAGE. THE DIMENSIONS OF THE COIL INTRODUCER SHEATH, COIL, AND DDT WERE MEASURED AND WERE WITHIN SPECIFICATION. IF THE PHYSICIAN FELT RESISTANCE PUSHING THE COIL OUT OF THE MICROCATHETER, THE COIL SHEATH WOULD NO LONGER HAVE BEEN ON THE COIL. THE RESISTANCE MAY HAVE OCCURRED DUE TO TORTUOSITY OF THE VESSEL. COMPRESSION OF THE COIL EXPOSING THE SR WIRE LIKELY OCCURRED WHEN THE COIL WAS PULLED BACK INTO THE INTRODUCER SHEATH DURING REMOVAL. THE KINK IN THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS NOT DESCRIBED IN THE COMPLAINT AND LIKELY OCCURRED AS A RESULT OF POST-PROCEDURAL HANDLING. THE RUBY COIL DETACHMENT HANDLE WAS TESTED AND FUNCTIONED WITHOUT AN ISSUE. THE HANDLE IS FUNCTIONAL. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THESE DEVICES ARE 100% FUNCTIONALLY TESTED DURING IN-PROCESS INSPECTION. 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 3005168196-2014-00654.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE. DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE DEPLOYING A RUBY COIL. THE PHYSICIAN REPOSITIONED THE MICROCATHETER IN AN ATTEMPT TO ALLEVIATE THE TENSION ON THE RUBY COIL; HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE RUBY COIL. IT WAS REMOVED AND A NEW COIL WAS USED. LATER IN THE PROCEDURE, THE PHYSICIAN DETACHED A RUBY COIL USING A RUBY COIL DETACHMENT HANDLE AND A FRAGMENT OF THE PUSHER WIRE REMAINED IN THE RUBY COIL DETACHMENT HANDLE. THE PROCEDURE CONTINUED USING A NEW RUBY COIL DETACHMENT HANDLE AND MORE RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581784 RUBY COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. F43821

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR