BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 13130519 · Received December 31, 2021

    Report

    Report Number
    3005168196-2021-02806
    Event Type
    Malfunction
    Date Received
    December 31, 2021
    Date of Event
    December 9, 2021
    Report Date
    March 29, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015699
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-02805.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP REPORT: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 2. SECTION H. BOX 6. DEVICE CODE 1, 2, AND 3. PLEASE NOTE THAT THE DEVICE IN COMPLAINT WAS NOT EXPECTED TO BE RETURNED; HOWEVER, ON 11/30/2021 THE DEVICE WAS RECEIVED. ADDITIONAL INFORMATION WAS ADDED TO: 1. SECTION D. BOX 10: RETURNED TO MANUFACTURER ON (MM/DD/YYYY). EVALUATION OF THE RETURNED SMART COIL REVEALED THAT THE EMBOLIZATION COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY. THIS COIL WAS DETACHED AND IMPLANTED IN THE PATIENT ACCORDING TO THE COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. PENUMBRA PRODUCTS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. PENUMBRA HANDLES ARE VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING INCOMING INSPECTION BY QUALITY. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1. 3005168196-2021-02805. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THEN, THE PHYSICIAN ADVANCED THREE SMART COILS (F106492, F106751, AND F106751) TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THEM USING A HANDLE; HOWEVER, THE SMART COILS FAILED TO DETACH. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS USING A SECOND HANDLE; HOWEVER, THEY WERE UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COILS USING A HEMOSTAT; HOWEVER, IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COILS WERE REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT SMART COIL (F86218) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. HOWEVER, UPON RETRACTING THE MICROCATHETER FROM THE ANEURYSM, THE SMART COIL CAME OUT OF THE ANEURYSM. THEREFORE, THE PHYSICIAN ADVANCED A SHORTER SMART COIL TO THE TARGET VESSEL TO PUSH THE PREVIOUSLY DETACHED SMART COIL BACK INTO THE ANEURYSM, AND SUBSEQUENTLY, THE PHYSICIAN RETRACTED AND REMOVED THE SHORTER SMART COIL. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN SMART COILS IN THE TARGET VESSEL USING A HANDLE. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL (F100753) TO THE TARGET VESSEL, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THEN, THE PHYSICIAN SUCCESSFULLY IMPLANTED ANOTHER SMART COIL IN THE TARGET VESSEL USING A HANDLE. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL (F106600) TO THE TARGET VESSEL, THE SMART COIL ALSO WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THEN, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE NEXT SMART COIL IN THE TARGET VESSEL USING A HANDLE. WHILE ATTEMPTING TO DETACH ANOTHER SMART COIL (F107389) IN THE TARGET VESSEL USING A HANDLE, THE SMART COIL ALSO FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. HOWEVER, UPON RETRACTING THE MICROCATHETER FROM THE ANEURYSM, THE SMART COIL CAME OUT OF THE ANEURYSM. THEREFORE, THE PHYSICIAN ADVANCED A SHORTER SMART COIL TO THE TARGET VESSEL TO PUSH THE PREVIOUSLY DETACHED SMART COIL BACK INTO THE ANEURYSM, AND SUBSEQUENTLY, THE PHYSICIAN RETRACTED AND REMOVED THE SHORTER SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. IT WAS ALSO REPORTED IT IS UNKNOWN WHICH HANDLE WAS USED TO COMPLETE THE PROCEDURE. 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 MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER (SL-10), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THEN, THE PHYSICIAN ADVANCED THREE SMART COILS (F106492, F106751, AND F106751) TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THEM USING A HANDLE; HOWEVER, THE SMART COILS FAILED TO DETACH. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS USING A SECOND HANDLE; HOWEVER, THEY WERE UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COILS USING A HEMOSTAT; HOWEVER, IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COILS WERE REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT SMART COIL (F86218) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, WAS UNSUCCESSFUL. UPON RETRACTING THE MICROCATHETER FROM THE ANEURYSM, THE SMART COIL ALSO ADVANCED INTO THE MICROCATHETER. THE SMART COIL THEN UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN ADVANCED A SHORTER SMART COIL TO THE TARGET VESSEL TO PUSH THE PREVIOUSLY DETACHED SMART COIL BACK INTO THE ANEURYSM. THE PHYSICIAN THEN RETRACTED AND REMOVED THE SHORTER SMART COIL FROM THE PATIENT. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN SMART COILS IN THE TARGET VESSEL USING A HANDLE. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL (F100753) TO THE TARGET VESSEL, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THEN, THE PHYSICIAN SUCCESSFULLY IMPLANTED ANOTHER SMART COIL IN THE TARGET VESSEL USING A HANDLE. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL (F106600) TO THE TARGET VESSEL, THE SMART COIL ALSO WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THEN, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE NEXT SMART COIL IN THE TARGET VESSEL USING A HANDLE. WHILE ATTEMPTING TO DETACH ANOTHER SMART COIL (F107389) IN THE TARGET VESSEL USING A HANDLE, THE SMART COIL ALSO FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL. HOWEVER, UPON RETRACTING THE MICROCATHETER FROM THE ANEURYSM, THE SMART COIL ALSO ADVANCED INTO THE MICROCATHETER. THE SMART COIL THEN UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN ADVANCED A SHORTER SMART COIL TO THE TARGET VESSEL TO PUSH THE PREVIOUSLY DETACHED SMART COIL BACK INTO THE ANEURYSM. THE PHYSICIAN THEN RETRACTED AND REMOVED THE SHORTER SMART COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. IT WAS ALSO REPORTED IT IS UNKNOWN WHICH HANDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023251 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0202 F107389 00814548015699

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female