BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12701087 · Received October 26, 2021

    Report

    Report Number
    3005168196-2021-02393
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 28, 2021
    Report Date
    February 16, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015712
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED SMART COIL COULD NOT CONFIRM THE REPORTED COMPLAINT. EVALUATION REVEALED THAT THE PET LOCK WAS SEPARATED, AND THE EMBOLIZATION COIL WAS DETACHED FROM THE PUSHER ASSEMBLY AND WAS NOT RETURNED FOR EVALUATION. BASED ON THE RETURN CONDITION, THE ROOT CAUSE OF THE DETACHMENT ISSUE DURING THE PROCEDURE COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED PUSHER ASSEMBLY KINKS. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT. PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY A PENUMBRA SALES REPRESENTATIVE ON 27-JAN-2022: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2021-02393. 1. SECTION D. BOX 4. LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER 2. SECTION H. BOX 4. DEVICE MANUFACTURE DATE THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2021-02388, 2. 3005168196-2021-02389, 3. 3005168196-2021-02390, 4. 3005168196-2021-02391, 5. 3005168196-2021-02392, 6. 3005168196-2021-02394, 7. 3005168196-2021-02396, 8. 3005168196-2021-02398, 9. 3005168196-2021-02399, 10. 3005168196-2021-02401, 11. 3005168196-2021-02402 H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH EIGHT OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598604 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0204 F88919 00814548015712

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown