BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD COIL

    MDR report key: 23229904 · Received October 6, 2025

    Report

    Report Number
    3005168196-2025-00320
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 17, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K141134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS UPDATED ON THIS FOLLOW-UP #01 MFR REPORT 3005168196-2025-00320: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE RETURNED POD COIL CONFIRMED THE EMBOLIZATION COIL WAS DETACHED FROM THE PUSHER ASSEMBLY. EVALUATION REVEALED THAT THE PUSHER ASSEMBLY HAD KINKS AND WAS FRACTURED, THE PULL WIRE WAS RETRACTED OUT OF THE DISTAL FRACTURED SEGMENT, AND THE EMBOLIZATION COIL WAS DETACHED WITHIN THE INTRODUCER SHEATH. IF THE POD COIL IS MANIPULATED AGAINST RESISTANCE, DAMAGE SUCH AS KINKS AND A SUBSEQUENT FRACTURE ON THE PUSHER ASSEMBLY MAY OCCUR, CAUSING THE EMBOLIZATION COIL TO DETACH. BASED ON THE REPORTED EVENT, THE ROOT CAUSE OF RESISTANCE COULD NOT BE DETERMINED. PENUMBRA DEVICES ARE 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. NOTE: BASED ON THE INVESTIGATION FINDINGS, THIS IS NOT CONSIDERED A REPORTABLE EVENT. THIS EVENT DID NOT AND, IF IT WERE TO RECUR, IT WOULD NOT CAUSE OR CONTRIBUTE TO SERIOUS DETERIORATION OR DEATH.

    Additional Manufacturer Narrative · 0

    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 · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A NON-PENUMBRA COIL (UNKNOWN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE LANTERN AND WAS UNABLE TO ADVANCE THE POD COIL ANY FURTHER. THE PHYSICIAN ATTEMPTED TO RETRACT THE POD COIL; HOWEVER, THE COIL DETACHED WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE LANTERN AND THE POD COIL WERE REMOVED FROM THE PATIENT, AND THE POD COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, TWO NON-PENUMBRA COILS AND A NON-PENUMBRA 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 INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A NON-PENUMBRA COIL. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE LANTERN AND WAS UNABLE TO ADVANCE THE POD COIL ANY FURTHER. THE PHYSICIAN ATTEMPTED TO RETRACT THE POD COIL; HOWEVER, IT UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT, AND THE POD COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, TWO NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868621 POD COIL HCG, KRD HCG PENUMBRA, INC. F00012223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown