BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2780755 · Received October 10, 2012

    Report

    Report Number
    3005168196-2012-00358
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: RESULTS: THE COIL AND THE PUSHER ARE SEPARATED. THE COIL APPEARS WELL FORMED BUT IS MISSING ITS PROXIMAL CONSTRAINT BALL. THE PUSHER PROXIMAL PET LOCK IS INTACT WHICH INDICATES AN UNDETACHED COIL. THE DISTAL DETACHMENT TIP (DDT) IS NOT PRESENT. CONCLUSION: THE UNINTENTIONAL DETACHMENT NOTED IN THE COMPLAINT IS CONFIRMED. THE CAUSE OF THE DETACHMENT IS THE BROKEN DISTAL SEGMENT OF THE PUSHER WHICH HAS HAD THE METAL DDT PULLED OFF OF THE POLYMER SECTION OF THE PUSHER ASSEMBLY. THIS WAS LIKELY CAUSED BY APPLYING TENSILE FORCE BEYOND THE SPECIFICATION OF THE MATERIAL TO THE DDT/PUSHER ASSEMBLY POLYMER BOND WHILE DRAWING THE COIL BACK INTO THE CATHETER. THA MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS.

    Description of Event or Problem · 1

    DURING TREATMENT OF A SIGMOID SINUS, THE COIL DETACHED DURING RETRIEVAL OF THE COIL INTO THE MICROCATHETER. THE MICROCATHETER WAS COMPLETELY TAKEN OUT OF THE PATIENT TOGETHER WITH THE COIL. THE PATIENT DID NOT SUFFER DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F22834

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR