BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 6395029 · Received March 10, 2017

    Report

    Report Number
    3005168196-2017-00343
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 9, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548010663
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 3005168196-2017-00340, 2. 3005168196-2017-00341, 3. 3005168196-2017-00342, 4. 3005168196-2017-00344, 5. 3005168196-2017-00345, 6. 3005168196-2017-00346. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA COILS 400 (PC400¿S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INITIAL PC400S THROUGH A PX SLIM WITHOUT A ROTATING HEMOSTASIS VALVE (RHV) AND CONTINUOUS FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND PC400S WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE NEW PC400S; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400S WOULD NOT ADVANCE THROUGH THE NEW PX SLIM. THEREFORE, THE PC400S WERE REMOVED. IT WAS REPORTED THAT AFTER CONNECTING THE PX SLIM WITH A RHV, A FLUSH LINE AND HOLDING THE HUB OF THE PX SLIM STRAIGHT, THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178502 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. A39882 00814548010663

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR