BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 5151995 · Received October 15, 2015

    Report

    Report Number
    3005168196-2015-01049
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 16, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548010649
    PMA / PMN Number
    K120330
    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 NUMBERS: 1. 3005168196-2015-01047. 2. 3005168196-2015-01048. HOSPITAL COULD NOT LOCATE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DUE TO THE TORTUOSITY OF THE PATIENT'S VESSELS, THE PHYSICIAN DECIDED TO DELIVER THE PC400 COILS FROM THE LEFT COMMON CAROTID ARTERY THROUGH A VASCULAR PROSTHESIS BYPASS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND THE COIL BECAME STUCK AND WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE PX SLIM BUT MET RESISTANCE AGAIN; THE COIL BECAME STUCK AND WAS REMOVED. 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
    684299 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F64344 00814548010649

    Patients

    Seq Age Sex Outcome Treatment
    1