BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TRUFILL PUSHABLE COIL

    MDR report key: 1880222 · Received October 22, 2010

    Report

    Report Number
    1058196-2010-00305
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 27, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    MCG
    PMA / PMN Number
    K983483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER OF THE TRUFILL COIL IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD IS NOT POSSIBLE. PROCEDURAL FACTORS THAT MAY HAVE IMPACTED THE EVENT INCLUDE VESSEL/LESION CHARACTERISTICS, INADEQUATE CONTINUOUS FLUSH THROUGH THE MICROCATHETER, AND DEVICE INTERACTION. BASED ON THE LACK OF CLINICAL INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE TRUFILL BECOMING IMPEDED IN THE UNKNOWN MICROCATHETER WHEN ADVANCED WITH THE TRUFILL COIL PUSHER. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE: THE CATALOG AND LOT NUMBER/(S) FOR THE ACTUAL PRODUCT/(S) USED IN THE PROCEDURE ARE UNKNOWN. AN INVESTIGATION IS IN PROCESS TO RETRIEVE THIS INFORMATION.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION OF AN UNKNOWN TARGET SITE WHEN THE TRUFILL COIL (UNKNOWN PRODUCT CODE) WAS ADVANCED USING THE TRUFILL COIL PUSHER THE COIL WAS STUCK AND STOPPED ADVANCING THROUGH THE UNKNOWN MICROCATHETER. THE SYSTEM WAS REMOVED AND CHANGED TO OTHER PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY. THERE WERE NO CONTRIBUTING ISSUES NOTED WITH THE COIL PUSHER OR THE MICROCATHETER. THE MICROCATHETER WAS FLUSHED AFTER EVERY COIL WAS DELIVERED. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRUFILL PUSHABLE COIL CNV_PUSHABLE COILS (MCG) MCG CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER