BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3971905 · Received July 31, 2014

    Report

    Report Number
    3005168196-2014-00494
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 2, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE PUSHER ASSEMBLY IS FRACTURED APPROXIMATELY 83.0 CM FROM THE DISTAL TIP. THE PULL WIRE IS EXPOSED OUT OF THE PROXIMAL END OF THE FRACTURED PUSHER ASSEMBLY. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT OUTSIDE THE BODY, THE COIL WAS BEING LOADED IN MICROCATHETER AND ENCOUNTERED SOME RESISTANCE. THE COIL WAS REMOVED FROM THE CATHETER AND THE PUSHER ASSEMBLY WAS WIPED DOWN WITH WET GAUZE. WHILE WIPING THE PUSHER ASSEMBLY, THE COIL INTRODUCER SHEATH MOVED DISTALLY, EXPOSING THE FLEXIBLE SECTION OF THE PUSHER ASSEMBLY. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL SHEATH BACK ON TO THE PUSHER ASSEMBLY HOWEVER, THE FLEXIBLE PORTION KINKED AND THE COIL COULD NOT BE USED. THE CAUSE OF THE RESISTANCE WHEN ATTEMPTING TO INTRODUCE THE COIL INTO THE MICROCATHETER IS UNKNOWN. THE MICROCATHETER DID NOT RETURN FOR EVALUATION AND THERE WAS NO INDICATION THAT THERE WAS ANY ISSUE WITH THE DEVICE. THE LIKELY CAUSE OF THE COIL INTRODUCER SHEATH SHIFTING DISTALLY WAS USER HANDLING WHEN WIPING THE PUSHER ASSEMBLY. THE USER LIKELY USED TOO MUCH FORCE AND PUSHED THE PROXIMAL END OF THE SHEATH DISTALLY ON THE COIL, EXPOSING THE FLEXIBLE SECTION. THE USER THEN ATTEMPTED TO PUSH THE SHEATH PROXIMALLY ON THE COIL OVER THE FLEXIBLE SECTION. THE USER SHOULD HAVE REMOVED THE COIL SHEATH FROM THE COIL AND RELOADED THE COIL PROPERLY FROM THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS LIKELY FRACTURED DUE TO HANDLING AFTER THE INCIDENT. 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 THE PENUMBRA COIL 400 SYSTEM. BEFORE THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A PENUMBRA COIL 400 THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE PENUMBRA COIL 400 AND ATTEMPTED TO WIPE DOWN THE DELIVERY WIRE WITH WET GAUZE AND THE PUSHER WIRE DROPPED OUT OF THE SHEATH. THE PHYSICIAN ATTEMPTED PUSH THE PUSHER WIRE BACK INTO THE SHEATH AND THE PUSHER WIRE BECAME KINKED. PHYSICIAN'S COMMENT: THE STOPPER DID NO WORK OUT. THE DELIVERY WIRE DROPPED EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446852 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F28616

    Patients

    Seq Age Sex Outcome Treatment
    1