BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD

    MDR report key: 12686759 · Received October 24, 2021

    Report

    Report Number
    3005168196-2021-02375
    Event Type
    Malfunction
    Date Received
    October 24, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 23, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548019611
    PMA / PMN Number
    K173614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED POD COIL REVEALED THAT THE PUSHER ASSEMBLY WAS PROXIMAL TO THE INTRODUCER SHEATH FRICTION LOCK. IF THIS OCCURS, RESISTANCE MAY BE EXPERIENCED DURING ADVANCEMENT, AND THE DEVICE MAY NOT ADVANCE AT ALL. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INDICATED THAT THE POD COIL WAS ABLE TO BE ADVANCED INTO THE MICROCATHETER. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED KINKS IN THE PUSHER ASSEMBLY. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT AND MAY HAVE OCCURRED DUE TO FORCEFUL ADVANCEMENT AGAINST RESISTANCE OR PACKING FOR RETURN. DURING THE FUNCTIONAL TEST, THE PUSHER ASSEMBLY MID-JOINT WAS ADVANCED THROUGH THE INTRODUCER SHEATH FRICTION LOCK WITH RESISTANCE. AFTER THE MID-JOINT WAS ADVANCED THROUGH THE FRICTION LOCK ADDITIONAL RESISTANCE WAS ENCOUNTERED DUE TO THE KINKS IN THE PUSHER ASSEMBLY AS THE EMBOLIZATION COIL WAS ADVANCED COMPLETELY OUT OF ITS INTRODUCER SHEATH. THE POD COIL WAS THEN ADVANCED THROUGH A DEMONSTRATION MICROCATHETER WITH RESISTANCE DUE TO THE KINKS IN THE PUSHER ASSEMBLY. PENUMBRA PRODUCTS 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 SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD COIL WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE POD COIL WAS REMOVED. THEN, THE PHYSICIAN ADVANCED ANOTHER POD COIL TO THE TARGET VESSEL; HOWEVER, THE POD COIL WAS DETERMINED TO BE TOO SMALL AND WOULD NOT FORM IN THE VESSEL. THEREFORE, THE POD COIL WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING A LARGER POD COIL 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
    1584921 POD HCG, KRD HCG PENUMBRA, INC. RBYPOD6-A F107075 00814548019611

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR