BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2222937 · Received August 10, 2011

    Report

    Report Number
    3005168196-2011-00296
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE SEPARATOR WAS RETURNED IN TWO PIECES, ONE OF THEM INSIDE THE CATHETER. THE CENTER SECTION OF THE SEPARATOR WAS REMOVED AFTER THE DECONTAMINATION PROCESS. THE DISTAL SECTION INCLUDING THE BULB REMAINS INSIDE THE CATHETER. THE PROXIMAL SECTION OF THE SEPARATOR IS 50.5 CM IN LENGTH AND IS HOOKED ON THE BROKEN END. THE CENTER SECTION IS HOOKED AT THE BREAK POINT AND IS 142 CM IN LENGTH. THE DISTAL TIP OF THE SEPARATOR REMAINS TRAPPED INSIDE THE CATHETER. THERE IS A FLAT SPOT IN THE CATHETER CENTERED AT 21 CM FROM THE DISTAL TIP. A 0.032" MANDREL WAS INTRODUCED INTO THE HUB OF THE CATHETER AND ADVANCED DISTALLY. THE MANDREL ADVANCED TO 21.2 CM FROM THE DISTAL TIP WHERE FORWARD PROGRESS STOPPED. THE CATHETER AND SEPARATOR ARE NON-FUNCTIONAL. CONCLUSION: THE DAMAGE NOTED IN THE COMPLAINT IS CONFIRMED. DURING DECONTAMINATION, THE STAINLESS STEEL CORE OF THE SEPARATOR APPEARS TO HAVE CORRODED IN THE PRESENCE SIGNIFICANT BLOOD THAT WAS TRAPPED IN THE CATHETER. THIS RESULTED IN THE BREAKAGE OF THE CORE WIRE WHEN THE SEPARATOR WAS REMOVED FROM THE CATHETER. THE CAUSE OF THE INITIAL BREAKAGE IN THE REGION OF THE PROXIMAL TAPER GRIND WAS LIKELY DUE TO THE FLAT SPOT IN THE CATHETER. THE FLAT SPOT CAUSED RESTRICTION OF THE MOVEMENT OF THE SEPARATOR BULB WHICH WOULD HAVE RESULTED IN THE KINKING AND EVENTUAL BREAKAGE AT THE SEPARATOR PROXIMAL TAPER GRIND AS THE PHYSICIAN CONTINUED TO MANIPULATE THE SEPARATOR WIRE. THE CATHETER MAY HAVE BECOME FLATTENED DUE TO ANATOMY OR OPERATOR HANDLING. 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 PHYSICIAN WAS TREATING A PT FOR THE LEFT MIDDLE CEREBRAL ARTERY OCCLUSION WITH THE PENUMBRA SYSTEM REPERFUSION CATHETER 032 AND PENUMBRA SYSTEM SEPARATOR 032. WHILE ATTEMPTING TO PULL BACK ON THE SEPARATOR, IT BROKE IN HALF LEAVING THE PHYSICIAN HOLDING APPROXIMATELY 12 INCHES OF THE PROXIMAL PORTION OF THE SEPARATOR. BOTH THE CATHETER AND THE SEPARATOR WERE REMOVED FROM THE PT. THERE WAS NO PT INJURY. THIS MDR IS ASSOCIATED WITH MDR 3005168196-00305.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY PENUMBRA, INC. F16573

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR