BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2103410 · Received May 17, 2011

    Report

    Report Number
    3005168196-2011-00216
    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

    RESULTS: THE CATHETER SHOWS A SINGLE LONG FLAT SPOT BETWEEN THE DISTAL TIP AND 29.5 CM PROXIMAL OF IT. THERE IS A KINK IN THE PROXIMAL SHAFT 32 CM DISTAL OF THE HUB. THE CATHETER IS NON-FUNCTIONAL. CONCLUSIONS: THIS UNIT WAS NOT MENTIONED IN THE COMPLAINT. THE DAMAGE APPEARS SIMILAR TO DAMAGE SEEN WHEN A CATHETER HAS BEEN WITHDRAWN THROUGH A PINCH POINT IN THE PATIENT'S ANATOMY. WITHOUT FURTHER INFORMATION ABOUT PATIENT ANATOMY, OR THE CONDITIONS OF THE CASE, NO FURTHER CONCLUSIONS CAN BE DRAWN. IT IS UNKNOWN IF THIS CATHETER WAS DAMAGED BEFORE OR AFTER THE PHYSICIAN ATTEMPTED TO USE THE OTHER REPERFUSION CATHETER AND SEPARATOR 032.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED INTO THE PULSE 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. A SECOND PENUMBRA SYSTEM REPERFUSION CATHETER 032 NOT MENTIONED IN THE COMPLAINT WAS ALSO RETURNED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00024 AND 3005168196-2011-00215.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1