BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PX SLIM DELIVERY MICROCATHETER

    MDR report key: 6517326 · Received April 24, 2017

    Report

    Report Number
    3005168196-2017-00635
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    March 23, 2017
    Report Date
    March 26, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548016412
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2017-00634. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING A PC400 25 CM INTO THE PX SLIM; CONSEQUENTLY, THE PC400 BECAME STUCK IN THE PX SLIM. THE PHYSICIAN THEREFORE, REMOVED THE PX SLIM WITH THE PC400 INSIDE, AND COMPLETED THE PROCEDURE USING A NEW PC400 AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298369 PX SLIM DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F72510 00814548016412

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR