BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD4

    MDR report key: 5159425 · Received October 19, 2015

    Report

    Report Number
    3005168196-2015-01065
    Event Type
    Malfunction
    Date Received
    October 19, 2015
    Date of Event
    September 19, 2015
    Report Date
    September 21, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013756
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 NUMBERS: 1. 3005168196-2015-01063 2. 3005168196-2015-01064.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND POD COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED THE PX SLIM INTO THE VERTEBRAL ARTERY BUT WAS UNABLE TO ADVANCE TWO DIFFERENT POD COILS THROUGH THE PX SLIM. THE PX SLIM AND POD COILS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690642 POD4 HCG, KRD HCG PENUMBRA, INC. F62047 00814548013756

    Patients

    Seq Age Sex Outcome Treatment
    1