BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POD PACKING COIL

    MDR report key: 9521765 · Received December 26, 2019

    Report

    Report Number
    3005168196-2019-02406
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 2, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548017655
    PMA / PMN Number
    K170852
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: 3005168196-2019-024061.SECTION B. BOX 2. OUTCOMES ATTRIBUTED TO ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. 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 INTERNAL ILIAC ARTERY (IIA) USING A POD PACKING COIL (POD PC), A POD6, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A POD6 WAS SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL USING THE LANTERN. NEXT, UPON ADVANCEMENT OF A POD PC, THE PHYSICIAN ENCOUNTERED RESISTANCE. DURING IMPLANTATION OF THE POD PC, WHEN APPROXIMATELY TEN CENTIMETERS OF THE COIL WAS ADVANCED INTO THE TARGET VESSEL, IT UNINTENTIONALLY DETACHED. WHILE ATTEMPTING TO RECAPTURE THE DETACHED COIL THE PHYSICIAN ENCOUNTERED RESISTANCE. HOWEVER, PART OF THE POD PC WAS ABLE TO BE SNARED OUT OF THE BODY AND A STENT DEVICE WAS USED TO EXCLUDE THE REMAINING COIL THAT COULD NOT BE REMOVED. THE PHYSICIAN THEN DECIDED TO END THE PROCEDURE SINCE THE INITIAL POD6 HAD SUCCESSFULLY OCCLUDED THE TARGET VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314213 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. RBYPODJ30-A F92269 00814548017655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention