BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 2761004 · Received September 26, 2012

    Report

    Report Number
    3005168196-2012-00327
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K103305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. ADDITIONAL INFORMATION ABOUT THIS CASE WAS PROVIDED IN A PROCEDURAL REPORT COLLECTED DURING THE PENUMBRA POST-MARKET ACE CLINICAL TRIAL. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. COIL IMPLANTED/PUSHER WIRE DISCARDED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS POSITIONING THE COIL IN A VERTEBRAL ANEURYSM THROUGH A PXSLIM MICROCATHETER. THERE WAS PROXIMAL TORTUOSITY IN THE VERTEBRAL ARTERY AND AN ACUTE ANGLE ACCESSING THE ANEURYSM. DURING THE REPOSITIONING AND WITHDRAW OF THE COIL, THE COIL PREMATURELY DETACHED. THE PHYSICIAN WAS ABLE TO FULLY ADVANCE THE COIL INTO THE ANEURYSM USING THE PUSHER WIRE. AN ADDITIONAL COIL WAS PLACED IN THE ANEURYSM AND BALLOON ANGIOPLASTY WAS PERFORMED TO SET THE COIL MASS AT THE NECK. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F26020

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR