BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3944198 · Received July 18, 2014

    Report

    Report Number
    3005168196-2014-00460
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE PUSHER IS KINKED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END OF THE PUSHER WHERE THE HYPO-TUBE TAB IS LOCATED. CONCLUSIONS: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT A KINK IN THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS DISCOVERED DURING REMOVAL FROM THE PACKAGING HOOP. EVALUATION OF THE RETURNED DEVICE CONFIRMED A KINK IN THE PROXIMAL END OF THE PUSHER ASSEMBLY. THIS DAMAGE WAS LIKELY CAUSED BY IMPROPER HANDLING DURING REMOVAL FROM THE PACKAGING. THESE DEVICES ARE 100% VISUALLY INSPECTED DURING PROCESSING. 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 USING THE PENUMBRA COIL 400 SYSTEM. BEFORE THE PROCEDURE, THE PHYSICIAN FOUND THE PROXIMAL END OF A PENUMBRA COIL 400 DELIVERY PUSHER WAS KINKED IN THE DISPENSER HOOP. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422357 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F40771

    Patients

    Seq Age Sex Outcome Treatment
    1