BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD COIL

    MDR report key: 22325650 · Received June 25, 2025

    Report

    Report Number
    3005168196-2025-00214
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 23, 2025
    Report Date
    December 4, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013831
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS UPDATED ON THIS FOLLOW-UP #01 MFR REPORT 3005168196-2025-00214: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE SECOND RETURNED POD COIL CONFIRMED THAT THE EMBOLIZATION COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY. EVALUATION REVEALED THAT THE PUSHER ASSEMBLY WAS FRACTURED, AND THE PULL WIRE WAS RETRACTED FROM ITS INITIAL POSITION ON THE DISTAL END OF THE PUSHER ASSEMBLY. IF THE POD COIL IS ADVANCED AGAINST RESISTANCE DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. BASED ON THE REPORTED COMPLAINT, THE ROOT CAUSE OF RESISTANCE COULD NOT BE DETERMINED. THE PUSHER ASSEMBLY FRACTURE LIKELY CONTRIBUTED TO THE EMBOLIZATION COIL DETACHMENT. 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. THIS REPORT IS ALSO ASSOCIATED WITH MFR REPORT NUMBER: 1. 3005168196-2025-00215.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A POD PACKING COIL (PACKING COIL), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH ANOTHER POD COIL AND A PACKING COIL. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED POD COIL AND PACKING COIL RESPECTIVELY. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO IMPLANT A POD COIL AND A POD PACKING COIL (PACKING COIL) AND NO ADDITIONAL DETAILS ARE AVAILABLE. THEREFORE, BOTH COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653681 POD COIL HCG, KRD HCG PENUMBRA, INC. F93635 00814548013831

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male