BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA RUBY COIL

    MDR report key: 3171262 · Received June 14, 2013

    Report

    Report Number
    3005168196-2013-00232
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE HAS BEEN RETURNED, BUT THE INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PUSHER ASSEMBLY IS BENT, BUT NOT FRACTURED. THESE KINKS ARE LOCATED ALONG THE ENTIRE HYPO-TUBE AT THE FOLLOWING APPROXIMATE AREAS; 22.5 CM, 42.8 CM, 62.8 CM, 78.3 CM, 97.3 CM, AND 115.8 CM FROM THE PROXIMAL END OF THE PUSHER. THE COIL IS STILL ATTACHED TO THE PUSHER ASSEMBLY. THE PROXIMAL PET LOCK IS BROKEN. THE PULL WIRE IS INTACT AND IN THE CAPTURE FEATURE. THE DISTAL TIP OF THE PUSHER HAS DRIED PATIENT BLOOD IN IT, CLOGGING THE DETACHMENT MECHANISM. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. NO BREAK IN THE PUSHER WAS NOTED AS STATED IN THE COMPLAINT. SEVERAL KINKS WERE PRESENT IN THE HYPOTUBE, BUT THE PERIODIC LOCATION OF THEM SUGGESTS THIS WAS DUE TO THE WAY IT WAS PACKAGED FOR RETURN SHIPPING. THE PET LOCK IS BROKEN, AND IT IS UNKNOWN WHETHER THIS WAS DONE WITH THE DETACHMENT HANDLE OR MANUALLY. THE COMPLAINT STATES THE COIL DETACHED, BUT THE PUSHER ASSEMBLY CAME BACK WITH THE COIL STILL ATTACHED TO THE DDT. THE COIL WAS ABLE TO BE DETACHED BY PULLING ON THE PROXIMAL END OF THE PUSHER WITHOUT APPLYING ANY EXCESSIVE FORCE. OTHER THAN MULTIPLE KINKS ON THE HYPOTUBE, THE COIL APPEARS TO HAVE FUNCTIONED PROPERLY. THE DAMAGE IN THIS COMPLAINT COULD NOT BE CONFIRMED. 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

    PATIENT WAS BEING TREATED FOR AVM OF THE LEG/ANKLE. DURING PROCEDURE THE PUSHER WIRE BROKE WHILE TRYING TO POSITION THE COIL. THE COIL ASSEMBLY WAS REMOVED AND NO COMPLICATIONS OCCURRED DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271840 PENUMBRA RUBY COIL HCG, KRD KRD PENUMBRA, INC. F32766

    Patients

    Seq Age Sex Outcome Treatment
    1