BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2443614 · Received January 24, 2012

    Report

    Report Number
    2954740-2012-00002
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    December 25, 2011
    Report Date
    December 26, 2011
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED SEVERELY DAMAGED. THE MOST LIKELY ROOT CAUSE OF THE COIL UNABLE TO BE ADVANCED THROUGH THE MICROCATHETER WAS DUE TO DETACHED DEBRIS CAUSING A BLOCKAGE. THIS CAUSED THE COIL TO STOP AND BECOME ANCHORED. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, "TO ACHIEVE OPTIMAL PERFORMANCE OF THE MICRUS MICROCOIL SYS, IT IS IMPORTANT THAT A CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION BE MAINTAINED. FIGURE 2 ILLUSTRATES THE CONNECTIONS NECESSARY FOR THE MICRUS MICROCOIL DELIVERY SYS INCLUDING A TYPICAL CONTINUOUS SALINE FLUSH SET UP WITH PRESSURE BAG FOR THE CATHETER SYSTEMS ..." IN ADDITION, WITHOUT THE RETURN OF THE PROWLER LPES 10 MICROCATHETER AND THE SEVERED PROXIMAL END OF THE COIL USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADD'L CONTRIBUTIONS TO THE COMPLAINT EVENT. THE MOST LIKELY ROOT CAUSE OF THE COIL BECOMING STRETCHED DURING REMOVAL WAS DUE TO EXTERNAL EXCESSIVE FORCE. THIS CAUSED THE ANCHORED COIL TO UNRAVEL OUT OF THE SOLDERED SECTION AND SEVER FROM THE REMAINING COIL. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, "CAUTION: IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYS, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICRUS MICROCOIL SYS AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYS. IF FRICTION STILL EXISTS, WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYS. CAUTION: IF THE MICRUS MICROCOIL SYS BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH PULL MOTION TO FREE IT.''

    Description of Event or Problem · 1

    PER RECEIVED REPORT: THE COIL WAS ADVANCED ONE THIRDS (1/3) INTO THE MICROCATHETER WHEN IT COULD NO LONGER BE ADVANCED FURTHER. THE COIL WAS WITHDRAWN AND FOUND STRETCHED. THE COIL WAS REPLACED WITH NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION G12810

    Patients

    Seq Age Sex Outcome Treatment
    1