BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA 5MAX REPERFUSION CATHETER

    MDR report key: 3171267 · Received June 14, 2013

    Report

    Report Number
    3005168196-2013-00234
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS: THE CATHETERS EXTRUSION IS SPLIT AND FOLDED OVER ITSELF. THE DAMAGE IS APPROXIMATELY 19.3 CM FROM THE DISTAL TIP. THE CATHETER IS KINKED APPROXIMATELY 43.4 CM FROM THE DISTAL TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT THE PHYSICIAN HAD DIFFICULTIES PASSING THE TREVO STENT RETRIEVER THROUGH THE 5MAX REPERFUSION CATHETER AFTER FOUR PRIOR PASSES. UPON EVALUATION OF THE CATHETER IT IS VISIBLE THAT THE 5MAX IS DAMAGED WITH A SPLIT AND KINK IN THE MID-JOINT AREA. THIS DAMAGE WOULD LIKELY PREVENT THE MOVEMENT OF THE STENT RETRIEVER INSIDE THE CATHETER. THE CAUSE OF THIS DAMAGE CANNOT BE DIRECTLY DETERMINED BY THIS COMPLAINT. HOWEVER, IT IS LIKELY THIS DAMAGE OCCURRED DUE TO THE CONTINUED MANIPULATION OF A STENT RETRIEVER DEVICE INSIDE THE CATHETER. THE FORCE USED WHEN MANIPULATING THE TREVO STENT RETRIEVER INSIDE THE CATHETER AND THE CATHETER INSIDE THE PATIENT LIKELY EXCEED THE TENSILE STRENGTH SPECIFICATION OF THE CATHETER MATERIAL CAUSING THE BREAK IN THE POLYMER EXTRUSION. 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

    5MAX REPERFUSION CATHETER WAS BEING USED IN COMBINATION WITH TREVO FOR RECANALIZATION IN THE M1 OF CEREBRA MEDIA. AFTER RETRIEVING THE TREVO FOUR TIMES INTO THE 5MAX CATHETER THE PHYSICIAN HAD DIFFICULTIES BRINGING THE TREVO BACK INTO THE 5MAX. A MICROCATHETER WAS USED TO RETRIEVE THE TREVO BACK INTO THE 5MAX. AFTER THE 5MAX CATHETER WAS REMOVED FROM THE PATIENT THE PHYSICIAN NOTED THERE WAS A LITTLE KNICK AND SMALL CUT IN THE INNER WALL OF THE 5MAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271715 PENUMBRA 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F33256

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR