BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 9666331 · Received February 4, 2020

    Report

    Report Number
    3005168196-2020-00126
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 15, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548017662
    PMA / PMN Number
    K170852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: 3005168196-2020-00126. 1.SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF ITS PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 113.0 CM FROM ITS PROXIMAL END. THE PUSHER ASSEMBLY WAS FRACTURED APPROXIMATELY 59.0 CM FROM ITS PROXIMAL END. THE EMBOLIZATION COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY AND THE PULL WIRE WAS RETRACTED OUT OF THE DISTAL DETACHMENT TIP (DDT). CONCLUSIONS: EVALUATION OF THE RETURNED POD PC REVEALED THAT THE PUSHER ASSEMBLY WAS FRACTURED. IF THE PUSHER ASSEMBLY IS MANIPULATED AGAINST RESISTANCE, DAMAGE SUCH AS A KINK MAY OCCUR. SUBSEQUENTLY, FURTHER MANIPULATION OF THE KINKED DEVICE MAY RESULT INTO A FRACTURE. FURTHER EVALUATION OF THE RETURNED POD PC REVEALED THAT THE EMBOLIZATION COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY. THIS LIKELY OCCURRED DUE TO THE SEPARATION OF THE TWO FRACTURED SEGMENTS, WHICH RESULTED IN THE PULL WIRE BEING RETRACTED OUT OF THE DDT AND CAUSING THE EMBOLIZATION COIL TO DETACH FROM ITS PUSHER ASSEMBLY. 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 · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE ILIOLUMBAR USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A POD PC WAS ADVANCED INTO THE TARGET VESSEL BUT REQUIRED RE-POSITIONING. WHILE RE-SHEATHING THE POD PC, THE TECHNICIAN ENCOUNTERED RESISTANCE AND THE PUSHER ASSEMBLY BECAME KINKED. DURING AN ATTEMPT TO RE-ADVANCE THE POD PC INTO THE LANTERN ON THE BACK TABLE, THE PHYSICIAN FOUND THAT THE COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED USING A NEW POD PC AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE ILIOLUMBAR USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A POD PC WAS ADVANCED INTO THE TARGET VESSEL BUT REQUIRED RE-POSITIONING. WHILE RE-SHEATHING THE POD PC, THE TECHNICIAN ENCOUNTERED RESISTANCE; SUBSEQUENTLY, THE PULL WIRE BECAME KINKED. THEREFORE, THE DEVICES WERE REMOVED FROM THE PATIENT. WHILE RE-ADVANCING THE POD PC INTO THE LANTERN ON THE BACK TABLE, THE PHYSICIAN FOUND THAT THE COIL HAD DETACHED. THE PROCEDURE WAS COMPLETED USING A NEW POD PC AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126320 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. RBYPODJ45-A F92735 00814548017662

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR