BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2103411 · Received May 17, 2011

    Report

    Report Number
    3005168196-2011-00215
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 10, 2011
    Report Date
    April 21, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER SHOWS MULTIPLE SMALL FLAT SPOTS BETWEEN THE DISTAL TIP AND THE MOST PROXIMAL FLAT SPOT AT 40.5 CM. A 0.032" MANDREL WAS INTRODUCED TO THE HUB OF THE CATHETER AND ADVANCED DISTALLY. THE MANDREL STOPPED DUE TO FRICTION APPROXIMATELY 22 CM FROM THE DISTAL TIP. THE CATHETER IS NON-FUNCTIONAL. CONCLUSIONS: THE FLAT SPOTS IN THE DISTAL PORTION OF THE CATHETER WOULD HAVE CREATED FRICTION WITH THE SEPARATOR BULB PUTTING FORCE ON THE PROXIMAL END OF THE SEPARATOR EVENTUALLY CAUSING IT TO KINK AND KNOT. ONCE A KNOT LIKE THIS HAS FORMED, FURTHER MANIPULATION WOULD CAUSE THE SEPARATOR TO BREAK. THE CAUSE OF THE FLAT SPOTS IN THE CATHETER IS UNKNOWN BUT COULD BE DUE TO ROUGH HANDLING OF THE CATHETER PRIOR TO INTRODUCTION OR TORTUOUS PATIENT ANATOMY. A SECOND PENUMBRA SYSTEM REPERFUSION CATHETER 032 NOT MENTIONED IN THE COMPLAINT WAS ALSO RETURNED. 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 ENROLLED INTO THE (B)(4) TRIAL AND TREATED FOR AN M1 MCA OCCLUSION WITH CLOT EXTENDING INTO THE SUPERIOR AND INFERIOR BRANCHES OF THE M2 SEGMENT. THE PULSE DEVICE WAS SUCCESSFUL IN REVASCULARIZING THE M1 AND M2 INFERIOR BRANCH, HOWEVER OCCLUSION REMAINED IN THE M2 SUPERIOR BRANCH. AN ATTEMPT WAS MADE TO REVASCULARIZE THE SUPERIOR M2 USING A PENUMBRA SYSTEM REPERFUSION CATHETER AND SEPARATOR 032. HOWEVER, THE PHYSICIAN WAS NOT ABLE TO DEPLOY THE SEPARATOR BECAUSE IT WAS SOMEHOW STUCK IN THE DISTAL PART OF THE CATHETER. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00024 AND 3005168196-2011-00216.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY PENUMBRA INC. F17381

    Patients

    Seq Age Sex Outcome Treatment
    1