BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 16970087 · Received May 19, 2023

    Report

    Report Number
    3005168196-2023-00240
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 19, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548017679
    PMA / PMN Number
    K170852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICE CODE THAT ALSO APPLY TO THIS COMPLAINT:1069 (BREAK). EVALUATION OF THE RETURNED POD PC CONFIRMED THAT THE EMBOLIZATION COIL WAS DETACHED FROM THE PUSHER ASSEMBLY. EVALUATION ALSO REVEALED THAT THE DISTAL TIP OF THE PUSHER ASSEMBLY WAS FRACTURED. IF THE DISTAL PORTION OF THE PUSHER ASSEMBLY CONTAINING THE EMBOLIZATION COIL FRACTURES, THE EMBOLIZATION COIL WILL DETACH. THIS FRACTURE LIKELY OCCURRED DUE TO RETRACTION AGAINST RESISTANCE. THE REPORTED VESSEL SPASM MAY HAVE CONTRIBUTED TO ADDITIONAL RESISTANCE EXPERIENCED DURING THE PROCEDURE. FURTHER EVALUATION REVEALED THAT THE PUSHER ASSEMBLY WAS KINKED IN MULTIPLE LOCATIONS ALONG ITS LENGTH. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT AND LIKELY OCCURRED DURING PACKAGING OF THE DEVICE FOR RETURN. 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 IN THE GASTRODUODENAL ARTERY (GDA) TO TREAT A GI BLEED USING POD PACKING COILS (POD PCS), NON-PENUMBRA COILS, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED A POD PC THROUGH THE MICROCATHETER. THEN, AFTER ADVANCING APPROXIMATELY HALF OF THE POD PC INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE POD PC WAS TOO LONG, AND THE VESSEL BEGAN TO SPASM. THEREFORE, THE PHYSICIAN BEGAN TO RETRACT THE POD PC BACK INTO THE MICROCATHETER. WHILE RETRACTING THE POD PC BACK INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD PC UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. SOME PART OF THE COIL WAS FOUND TO BE UNRAVELED. NEXT, THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER CONTAINING THE DETACHED POD PC, AND THE POD PC UNRAVELED FURTHER INSIDE THE VESSEL. THEN, THE PHYSICIAN MADE THREE ATTEMPTS USING A SNARE DEVICE TO RETRIEVE THE POD PC; HOWEVER, THE POD PC BROKE AT EACH ATTEMPT AND MOST OF THE COIL FRAGMENTS WERE SNARED OUT. IT WAS REPORTED SOME OF THE POD PC WAS LEFT IN THE HEPATIC ARTERY AND THE DISTAL END OF THE POD PC WAS ANCHORED IN THE TWO PREVIOUSLY PLACED NON-PENUMBRA COILS. THE VASOSPASM RESOLVED WITHOUT ANY MEDICATION. THE PROCEDURE WAS COMPLETED USING ANOTHER NON-PENUMBRA COIL, THE SAME MICROCATHETER, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511181 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. F00005366 00814548017679

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female