BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4103684 · Received September 19, 2014

    Report

    Report Number
    3005168196-2014-00645
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE COIL WAS COMPRESSED DISTALLY, EXPOSING THE STRETCH RESISTANT (SR) WIRE. THE PET-LOCK WAS STILL INTACT. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 29.0, 83.0, AND 89.0 CM FROM THE PROXIMAL END OF THE WIRE. THE COIL INTRODUCER SHEATH IS DAMAGED APPROXIMATELY 5.5 CM FROM THE PROXIMAL END. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT RESISTANCE WAS FELT WHILE ADVANCING THE COIL THROUGH THE PXSLIMSTR MICROCATHETER. THE MICROCATHETER WAS REPOSITIONED AND RESISTANCE WAS STILL FELT WHILE TRYING TO ADVANCE THE COIL. THE MICROCATHETER WAS REMOVED WHILE THE COIL WAS STILL INSIDE. EVALUATION OF THE RETURNED DEVICE REVEALED DAMAGE TO THE COIL AND PUSHER ASSEMBLY, IN ADDITION TO DAMAGE TO THE COIL INTRODUCER SHEATH. THE PXSLIM MICROCATHETER WAS EVALUATED AND NO DAMAGE WAS OBSERVED. THE DEVICE APPEARS TO HAVE BEEN FULLY FUNCTIONAL. THE KINKS IN THE PUSHER ASSEMBLY WERE LIKELY DUE TO REPEATED ATTEMPTS TO ADVANCE THE DEVICE AGAINST RESISTANCE. THE COIL LOOPS MAY HAVE BEEN COMPRESSED WHEN PULLING THE COIL BACK INTO THE DAMAGED INTRODUCER SHEATH WHICH APPEARS TO HAVE BEEN PINCHED OR TWISTED DURING INSERTION INTO THE PATIENT. THE COIL DIMENSIONS WERE WITHIN SPECIFICATION. THERE IS NO INDICATION OF ANY DEVICE ISSUE. THE CAUSE OF THE REPORTED RESISTANCE COULD NOT BE DETERMINED BASED ON THE RETURNED DEVICE EVALUATION HOWEVER, RESISTANCE IF OFTEN CAUSED BY TORTUOUS PATIENT ANATOMY. THE COILS ARE 100% FUNCTIONALLY TESTED DURING IN-PROCESS INSPECTION AND THE MICROCATHETERS ARE 100% VISUALLY INSPECTED DURING PROCESSING. 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 3005168196-2014-00646.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE DEPLOYING A RUBY COIL THROUGH PX SLIM DELIVERY MICROCATHETER. THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND IT BECAME STUCK INSIDE THE PX SLIM DELIVERY MICROCATHETER. THE PHYSICIAN REMOVED THE PX SLIM DELIVERY MICROCATHETER WITH THE RUBY COIL INSIDE OF IT. A NEW PX SLIM DELIVERY MICROCATHETER AND RUBY COIL WERE USED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581624 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F43618

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR