BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 026

    MDR report key: 2043203 · Received February 24, 2011

    Report

    Report Number
    3005168196-2011-00060
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 25, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULT: THE DISTAL PORTION OF THE BROKEN SEPARATOR WAS LODGED IN THE REPERFUSION CATHETER. THE BREAK POINT WAS 4.8 CM FROM THE BEGINNING OF THE GREEN PTFE COATING. THE DISTAL PORTION OF THE BROKEN SEPARATOR WAS EXTRACTED FROM THE CATHETER AND WAS HOOKED ON THE BROKEN END. THE DISTAL PORTION WAS ALSO KINKED IN A "Z" APPROXIMATELY 13 CM DISTAL OF THE BREAK. THE SEPARATOR IS NON-FUNCTIONAL. CONCLUSION: DURING THE PROCEDURE, THE SEPARATOR MAY HAVE KINKED IF IT WAS ADVANCED AGAINST RESISTANCE SUCH AS A HARD CLOT OR THE MINOR KINK IN THE CATHETER. ADD'L MANIPULATION AGAINST THIS RESISTANCE MAY HAVE FURTHER KINKED SEPARATOR EVENTUALLY LEADING TO A BREAK. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS MOVING THE SEPARATOR BACK AND FORTH IN THE PROCESS OF ASPIRATING THE CLOT AND THE SEPARATOR BROKE INSIDE THE CATHETER. THE CATHETER WAS REMOVED ALONG WITH BOTH SECTIONS OF THE SEPARATOR WITH NO ADD'L EVENTS REPORTED. THE PT'S DISPOSITION AND OUTCOME WERE NOT EFFECTED BY THE EVENT. IT WAS NOT NECESSARY TO USE ANOTHER DEVICE AS THE VESSEL WAS NOW OPEN. THE PHYSICIAN WAS HAPPY WITH THE OUTCOME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 026 NRY PENUMBRA, INC. F17026

    Patients

    Seq Age Sex Outcome Treatment
    1