BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 7010289 · Received November 8, 2017

    Report

    Report Number
    3005168196-2017-01961
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 12, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016726
    PMA / PMN Number
    K170852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA: K170852.

    Additional Manufacturer Narrative · 1

    RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 72.5 AND 104.5 CM FROM THE PROXIMAL END. THE EMBOLIZATION COIL WAS INTACT WITH ITS PUSHER ASSEMBLY. THE EMBOLIZATION COIL WAS ADVANCED OUT OF ITS INTRODUCER SHEATH WITH A KNOT IN IT. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE PODJ PUSHER ASSEMBLY WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICE IS FORCEFULLY ADVANCED, THEN RESISTANCE IS ENCOUNTERED, DAMAGE SUCH AS A KINK MAY OCCUR. FURTHER EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE EMBOLIZATION COIL HAD A KNOT IN IT. THE KNOT IN THE EMBOLIZATION COIL WAS LIKELY INCIDENTAL AND MAY HAVE OCCURRED WHILE PACKAGING THE DEVICE FOR RETURN TO PENUMBRA HEADQUARTERS. THE LANTERN MENTIONED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. PENUMBRA COILS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A PODJ USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING THE SECOND PODJ INTO THE LANTERN, ITS PUSHER WIRE BECAME KINKED AND THE PODJ COULD NOT BE ADVANCED MORE THAN ABOUT 50 CM INTO THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE PODJ AND COMPLETED THE PROCEDURE USING THE SAME LANTERN AND ADDITIONAL PODJS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790376 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. F77154 00814548016726

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR