BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA RUBY COIL

    MDR report key: 3250660 · Received July 26, 2013

    Report

    Report Number
    3005168196-2013-00294
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 28, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PET LOCK ON THE PROXIMAL END OF THE PUSHER ASSEMBLY IS STILL INTACT AND THE CONSTRAINT BALL IS STILL IN THE DISTAL DETACHMENT TIP (DDT). HOWEVER, THE COIL HAS A BROKEN STRETCH RESISTANT (SR) WIRE. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT DURING REPOSITIONING, THE COIL DETACHED FROM THE PUSHER. DURING THE INVESTIGATION IT WAS NOTED THAT THE DISTAL OF THE PET LOCK, APPROXIMATELY 1.7 CM FROM THE HYPO-TUBE, IS BROKEN. THE COIL CONSTRAINT BALL IS STILL IN THE DDT AND THE PROXIMAL PET LOCK IS INTACT. THE UNINTENTIONAL DETACHMENT OF THE COIL WAS CAUSED BY THE BREAK IN THE COIL SR WIRE DURING MANIPULATION IN THE PATIENT. IT IS LIKELY THAT THE FORCE USED WHEN REPOSITIONING THE COIL IN THE PATIENT WAS GREATER THAN THE TENSILE STRENGTH OF THE SR WIRE MATERIAL, CAUSING THE WIRE TO BREAK AND RELEASE THE COIL. IT IS UNKNOWN WHEN THE PROXIMAL END OF THE PUSHER ASSEMBLY HYPOTUBE WAS BROKEN BUT WAS LIKELY UNRELATED TO THE DETACHMENT. 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

    PHYSICIAN WAS TREATING A GI BLEED BY EMBOLIZING A GDA VESSEL WITH THE RUBY COIL SYSTEM. A 3MM X 20 CM COMPLEX STANDARD RUBY COIL WAS DEPLOYED THROUGH A PXSLIM MICROCATHETER. UPON REPOSITIONING THE COIL, THE COIL DETACHED FROM THE PUSHER. THE PHYSICIAN THEN TOOK A 60CC SYRINGE AND ASPIRATED THE COIL BACK INTO THE CATHETER AND REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. THERE WAS NO ADVERSE OUTCOME FROM THIS DETACHMENT. THE PXSLIM WAS THEN REINTRODUCED INTO THE VESSEL AND EMBOLIZED USING A NEW COIL FROM INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350040 PENUMBRA RUBY COIL HCG, KRD KRD PENUMBRA, INC. F34486

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR