BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 7131196 · Received December 19, 2017

    Report

    Report Number
    3005168196-2017-02258
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 24, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016726
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2017-02258. PLEASE NOTE THAT THE FOLLOWING SECTION WAS INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND IS BEING INCLUDED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2017-02258. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2017-02257, 3005168196-2017-02259, 3005168196-2017-02260.

    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. 3005168196-2017-02257, 2. 3005168196-2017-02259, 3. 3005168196-2017-02260. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS), POD8S AND POD6S. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PODJ; HOWEVER, UPON RETRACTION, THE PODJ UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY; HOWEVER, IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PODJ, A POD8 AND A POD6. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PODJ COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907691 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. F78713 00814548016726

    Patients

    Seq Age Sex Outcome Treatment
    1