BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL DETACHMENT HANDLE

    MDR report key: 12345764 · Received August 19, 2021

    Report

    Report Number
    3005168196-2021-01853
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    August 2, 2021
    Report Date
    December 27, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548016139
    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

    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: 3005168196-2021-01853: SECTION H. BOX 6. DEVICE CODE 1. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01852; 3005168196-2021-01854; 3005168196-2021-01855; 3005168196-2021-01856; 3005168196-2021-01857.

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED HANDLE COULD NOT CONFIRM THE REPORTED COMPLAINT. FURTHER EVALUATION REVEALED THAT THE NOSECONE WAS DETACHED FROM THE HANDLE BODY AND NOT RETURNED FOR EVALUATION. BASED ON THE RETURNED CONDITION, FUNCTIONAL TESTING COULD NOT BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THERE WERE NO OTHER DAMAGES OBSERVED ON THE HANDLE. PENUMBRA HANDLES ARE VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING INCOMING INSPECTION. SECTION H BOX 6 (4316): THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED COMPLAINT DUE TO THE RETURN CONDITION. 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: 3005168196-2021-01852, 3005168196-2021-01854, 3005168196-2021-01855, 3005168196-2021-01856, 3005168196-2021-01857.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01852, 3005168196-2021-01854, 3005168196-2021-01855, 3005168196-2021-01856, 3005168196-2021-01857.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL HANDLES (HANDLES). DURING THE PROCEDURE, THREE SMART COILS WOULD NOT DETACH WITH THE THREE HANDLES AND WERE MANUALLY DETACHED. THEREFORE, THE HANDLES WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242658 PENUMBRA SMART COIL DETACHMENT HANDLE HCG, KRD HCG PENUMBRA, INC. SCH1 F101089 00814548016139

    Patients

    Seq Age Sex Outcome Treatment
    1 Female