BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2895583 · Received January 3, 2013

    Report

    Report Number
    3005168196-2013-00008
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THA MANUFACTURING RECORDS FOR THIS LOR WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    DURING TREATMENT OF AN UNRUPTURED ANEURYSM, THE PHYSICIAN HAD TRACKED ONE PXSLIM STRAIGHT SUCCESSFULLY IN THE PATIENT AND WHEN PUSHING FIRST COIL NOTICED THE DETACHMENT ZONE WOULD NOT PUSH COMPLETELY OUT INTO ANEURYSM WITH ABOUT 1 CM TO GO AND THOUGHT MAYBE THE COIL KINKED INSIDE OF THE MICROCATHETER AND KINKED THE CATHETER. THE PHYSICIAN TRIED A SECOND COIL AND SAME THING HAPPENED. HE THEN REMOVED PXSLIM FROM THE PATIENT AND NOTICED A SMALL KINK BETWEEN DISTAL AND PROXIMAL MARKERS ON CATHETER. HE USED ANOTHER PXSLIM SUCCESSFULLY. THERE WERE NO PATIENT ISSUES RELATED TO THIS DEVICE ISSUE. MDRS 3005168196-2013-00007 AND 3005168196-2013-00008 ARE RELATED TO THE SAME PATIENT/EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051 PENUMBRA COIL 400 HCG HCG PENUMBRA, INC. F27785

    Patients

    Seq Age Sex Outcome Treatment
    1