BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA RUBY COIL

    MDR report key: 2981295 · Received February 27, 2013

    Report

    Report Number
    3005168196-2013-00250
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE COIL STRETCH RESISTANT (SR) WIRE IS BROKEN. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLIANT INDICATES THAT THE THIRD COIL DELIVERED FELT STIFF AS IT WAS TRACKED DISTALLY IN THE PXSLIM MICROCATHETER. THE COIL BEGAN TO UNFOLD NICELY IN THE ANEURYSM, BUT STIFFNESS OCCURRED AGAIN AFTER REPOSITIONING. THE COIL SUBSEQUENTLY BROKE INSIDE OF THE PXSLIM MICROCATHETER. BASED ON THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, IT APPEARS THAT THE FORCE PLACED ON THE COIL DURING REPOSITIONING EXCEEDED THE TENSILE STRENGTH SPECIFICATION OF THE SR WIRE CAUSING THE WIRE TO BREAK AND THE COIL TO DETACH. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    DEVICE CATALOG NUMBER CORRECTION.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    PENUMBRA RUBY COILS WERE BEING USED IN AN ANEURYSM EMBOLIZATION CASE. TWO COILS WERE PLACED SUCCESSFULLY, BUT DURING PLACEMENT OF THE THIRD COIL STIFFNESS WAS FELT AS IT WAS TRACKED DISTALLY IN THE DELIVERY MICROCATHETER. THE COIL BEGAN TO UNFOLD NICELY IN TARGET ANEURYSM, BUT STIFFNESS WAS FELT AGAIN AFTER IT WAS REPOSITIONED. A FLOURO RUN WAS TAKEN AND IT APPEARED THE COIL PREMATURELY DETACHED OR BROKE FROM THE REST OF THE COIL/PUSHER ASSEMBLY. THE PHYSICIAN WAS HAPPY WITH THE COIL MASS IN THE ANEURYSM, BUT STILL NOTED THE PROXIMAL PART OF THE COIL LOOKED STRANGE, AND IT WASN¿T APPARENT IF IT WAS JUST THE PUSHER WIRE OR SOME OF THE COIL HAD BROKEN OFF. SINCE THE COIL MASS LOOKED GOOD IN THE ANEURYSM THE PHYSICIAN WITHDREW THE SYSTEM AND DECLARED THE CASE A SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83883 PENUMBRA RUBY COIL HCG, KRD KRD PENUMBRA, INC. F34782

    Patients

    Seq Age Sex Outcome Treatment
    1