BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 6793418 · Received August 14, 2017

    Report

    Report Number
    3005168196-2017-01389
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 14, 2017
    Report Date
    July 20, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548017051
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING INCLUDED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2017-01389. 1. SECTION H. BOX 3. ''OTHER'' REASON FOR NON-EVALUATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1. 3005168196-2017-01388.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISPOSED OF BY THE HOSPITAL AND IS NO LONGER AVAILABLE FOR RETURN. 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: 3005168196-2017-01388. THE PRODUCT WAS DISPOSED OF BY THE HOSPITAL AND IS NO LONGER AVAILABLE FOR RETURN. 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 TO TREAT AN ANTERIOR CAROTID ARTERY (ACA) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, BUT WHILE ATTEMPTING TO DETACH THE SMART COIL USING THE HANDLE THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) WAS SEPARATED ENOUGH; HOWEVER, UPON VISUAL AND FLUOROSCOPIC INSPECTION, THE PHYSICIAN NOTICED THAT THE SMART COIL WAS NOT SUCCESSFULLY DETACHED. THE PHYSICIAN THEN MADE A COUPLE OF MORE ATTEMPTS; HOWEVER, THE SMART COIL WOULD STILL NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING SEVEN NON-PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573740 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F73574 00814548017051

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR