BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 360 8MM X 20CM SR

    MDR report key: 3941710 · Received July 17, 2014

    Report

    Report Number
    3008853977-2014-00213
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE MAIN COIL WAS STRETCHED AND BROKEN AWAY FROM THE PUSHER WIRE DISTAL TO THE INNER COIL. THE DELIVERY WIRE WAS KINKED AT MULTIPLE LOCATIONS ALONG ITS LENGTH. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE INTRODUCER SHEATH WAS NOT RETURNED AND THE MAIN COIL WAS BROKEN. BASED ON THE INFORMATION AVAILABLE AND THE INVESTIGATION, IT IS LIKELY THAT THE HANDLING OF THE DEVICE DURING THE PROCEDURE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING DEVICE ANALYSIS IT WAS NOTED THAT THE MAIN COIL WAS BROKEN AWAY FROM THE PUSHER WIRE DISTAL TO THE INNER COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    DURING DEVICE ANALYSIS IT WAS NOTED THAT THE MAIN COIL WAS BROKEN AWAY FROM THE PUSHER WIRE DISTAL TO THE INNER COIL. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418828 GDC-10 360 8MM X 20CM SR DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15875571

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR