BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR FLEX 041

    MDR report key: 1963517 · Received December 20, 2010

    Report

    Report Number
    3005168196-2010-00704
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K100769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THERE IS A BREAK IN THE PROXIMAL SECTION OF THE SEPARATOR 4.0 CM AFTER THE GREEN PTFE COATING BEGINS. THE DISTAL SIDE OF THE BREAK IS HOOKED. THE SEPARATOR IS NON FUNCTIONAL. CONCLUSION: THE COMPLAINT IDENTIFIED THE CLOT AS TENACIOUS AND FIBROUS WITH SEVERAL 054 SEPARATORS USED AND DISCARDED BEFORE THE (B)(4) WAS USED. SIMILAR SITUATIONS HAVE RESULTED IN OVER-VIGOROUS SEPARATOR STROKES BY THE PHYSICIAN. THIS CAN CAUSE THE KNOTTING AND EVENTUAL BREAKAGE AS SEEN IN THIS CASE. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING MECHANICAL THROMBECTOMY OF A PROXIMAL M1 CLOT USING A REPERFUSION CATHETER 054. THE CLOT WAS VERY FIBROUS AND THE PHYSICIAN WENT THROUGH TWO 054 SEPARATORS DURING THE CASE. A SEPARATOR 041 WAS THEN USED DUE TO DEPLETING STOCK OF THE SEPARATOR 054. THE PROXIMAL SHAFT OF THE SEPARATOR 041 THEN BROKE IN THE RHV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR FLEX 041 PERCUTANEOUS CATHETER NRY PENUMBRA, INC. F17067

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR