BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POD PACKING COIL

    MDR report key: 14195286 · Received April 25, 2022

    Report

    Report Number
    3005168196-2022-00190
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    September 10, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548017648
    PMA / PMN Number
    K170852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, 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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY A PENUMBRA SALES REPRESENTATIVE ON 4/22/2022: SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (POD PC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD PC INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE POD PC FAILED TO DETACH. THE PHYSICIAN MADE ANOTHER ATTEMPT TO DETACH THE POD PC USING THE HANDLE, BUT THE COIL WOULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE POD PC; HOWEVER, DURING THE ATTEMPT, THE PHYSICIAN INADVERTENTLY PULLED BACK ON THE POD PC AND THE COIL HAD UNINTENTIONALLY DETACHED AND MIGRATED INTO THE DISTAL COMMON HEPATIC ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED POD PC. THE PROCEDURE HAD ENDED AT THIS POINT AS THE PHYSICIAN DETERMINED NO ADDITIONAL COILS WERE NEEDED. 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 GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (POD PC), A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD PC INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE POD PC FAILED TO DETACH. THE PHYSICIAN MADE ANOTHER ATTEMPT TO DETACH THE POD PC USING THE HANDLE, BUT THE COIL WOULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE POD PC; HOWEVER, DURING THE ATTEMPT, THE PHYSICIAN INADVERTENTLY PULLED BACK ON THE POD PC AND THE COIL HAD UNINTENTIONALLY DETACHED AND MIGRATED INTO THE DISTAL COMMON HEPATIC ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED POD PC. THE PROCEDURE HAD ENDED AT THIS POINT AS THE PHYSICIAN DETERMINED NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199257 POD PACKING COIL HCG, KRD HCG PENUMBRA, INC. RBYPODJ15-A F111705 00814548017648

    Patients

    Seq Age Sex Outcome Treatment
    1 Female