BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PX SLIM DELIVERY MICROCATHETER

    MDR report key: 6038526 · Received October 18, 2016

    Report

    Report Number
    3005168196-2016-01486
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016436
    PMA / PMN Number
    K100826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA COIL 400S (PC400) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PC400 UNINTENTIONALLY DETACHED AS IT WAS BEING RETRACTED INTO THE 45 DEGREE PX SLIM TO BE REPOSITIONED, AND MIGRATED TO THE MIDDLE CEREBRAL ARTERY. THE 45 DEGREE PX SLIM WAS REMOVED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED PC400 USING ANOTHER MANUFACTURER'S STENT RETRIEVER THROUGH ANOTHER MANUFACTURER'S MICROCATHETER; HOWEVER, THE PC400 BROKE INTO TWO PIECES AND ONLY PART OF THE COIL WAS RETRIEVED. THE SECOND PART WAS REMOVED ON ANOTHER PASS WITH THE STENT RETRIEVER, OPENING THE BLOCKED VESSEL. SUBSEQUENTLY, THE PHYSICIAN USED A NEW PX SLIM STRAIGHT AND IMPLANTED TWO PC400 COILS. THE PHYSICIAN THEN NOTICED ON THE ANGIOGRAPHY IMAGE THAT THE ANEURYSM WAS BLEEDING, AND REPORTED THAT THE PX SLIM CAUSED THE RUPTURE BY TOUCHING THE ANEURYSM DOME. THE PHYSICIAN THEN IMPLANTED TWO ADDITIONAL PC400 COILS; THE BLEEDING STOPPED, AND THE PROCEDURE WAS THEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689821 PX SLIM DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F68955 00814548016436

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention