BEUDAMED
    FDA Adverse Event Other Summary report: N

    032 SEPARATOR

    MDR report key: 1532685 · Received November 17, 2009

    Report

    Report Number
    3005168196-2009-00106
    Event Type
    Other
    Date Received
    November 17, 2009
    Date of Event
    October 20, 2009
    Report Date
    October 20, 2009
    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

    TECHNICAL EVALUATION: TWO 032 SEPARATORS WERE RETURNED. THERE WAS NO WAY TO TELL THE DIFFERENCE BETWEEN THE SEPARATORS IN REF TO THEIR LOT NUMBERS. ONE OF THE SEPARATORS WAS RETURNED WITH TWO BROKEN PROXIMAL ENDS. IN ADDITION, THE 032 CATHETER WAS RETURNED WITH THE BALANCE OF ONE OF THE SEPARATORS LODGED IN IT. THE PROXIMAL END OF ONE OF THE BROKEN SEPARATORS WAS IN A SMALL TWISTED KNOT INSIDE THE CATHETER AND IMPOSSIBLE TO REMOVE. THE INCIDENT WAS CONFIRMED AS REPORTED AND THE DEVICE FAILURES SEEM TO ALIGN WITH THE PHYSICIAN'S STATEMENT THAT SHE MAY HAVE USED THE SYSTEM WITH TOO MUCH FORCE. A DHR OF THIS MFG LOT HAS BEEN REVIEWED.

    Description of Event or Problem · 1

    PT HAD A CLOT AT THE M1/M2 TRANSITION. THE PHYSICIAN FIRST PLACED THE 070 NEURON, BUT COULD NOT PLACE IT AS HIGH AS IT SHOULD HAVE BEEN DUE TO PT ANATOMY. THE PHYSICIAN THEN USED THE 032 SYSTEM (PSC032 AND PSC032) TO RECANALIZE THE VESSEL. THE PHYSICIAN OBSERVED THE SEPARATOR FRACTURED AND THEN PLACED A SECOND SEPARATOR WHICH ALSO FRACTURED. SHE THEN DECIDED TO PULL THE ENTIRE 032 SYSTEM BACK AND REPLACED IT WITH THE 041 SYSTEM. THE 041 SYSTEM ALLOWED HER TO RECANALIZE SOME OF THE VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 032 SEPARATOR WIRE SEPARATOR NRY PENUMBRA, INC. F14991

    Patients

    Seq Age Sex Outcome Treatment
    1