BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 4072326 · Received September 9, 2014

    Report

    Report Number
    1226348-2014-00434
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SL-10 MICROCATHETER WAS NOT RETURNED. LOCATED ADJACENT, BUT PROXIMAL TO THE DISTAL TIP OF THE SKIVE, THE DPU PROTRUDES OUTSIDE THE SHEATH FOR 1.0 CM. THERE IS A COPIOUS AMOUNT OF CONTRAST AT THE COIL'S PROTRUSION SITE. AT THE EXACT PROTRUSION POINT OF THE COIL,THERE IS COMPRESSION, BUCKLING, AND A LARGE AMOUNT OF A BLOOD MIXTURE CONTAINING CONTRAST. THE COIL'S SOCKET RING WAS FOUND LODGED DOWN INSIDE THE OUTER SHEATH. DISTAL TO THE STRETCHED SECTION, THE REMAINDER OF THE COIL IS UNDAMAGED. THE COIL WAS RETURNED SEVERELY DAMAGED. THE EVIDENCE SUGGESTS THE COILS RESISTANCE INSIDE THE MICROCATHETER MAY HAVE BEEN DUE TO DETACHED DEBRIS. THIS DEBRIS WAS IN THE FORM OF A BLOOD MIXTURE WITH CONTRAST BEING SIGNIFICANTLY PRESENT IN COPIOUS AMOUNTS. IN ADDITION; WITHOUT THE RETURN OF THE SL-10 MICROCATHETER USED IN THE PROCEDURE; IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. A COPIOUS AMOUNT OF DETACHED DEBRIS (WITH CONTRAST AS THE MAIN INGREDIENT) WAS FOUND AT THE DAMAGED SECTION OF COIL AND AT THE PROTRUSION SITE ON THE SHEATH. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS; THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS; ¿TO ACHIEVE OPTIMAL PERFORMANCE OF THE MICRUS MICROCOIL SYSTEM; 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 SYSTEM INCLUDING A TYPICAL CONTINUOUS SALINE FLUSH SET UP WITH PRESSURE BAG FOR THE CATHETER SYSTEMS. ATTACH A ROTATING HEMOSTATIC VALVE (RHV) TO THE HUB OF THE GUIDING CATHETER. CONNECT A THREE WAY STOPCOCK TO THE RHV SIDEARM; AND ATTACH A LINE TO THE STOPCOCK FOR THE CONTINUOUS INFUSION OF SOLUTION. CAREFULLY SELECT AN APPROPRIATELY SIZED INFUSION MICROCATHETER BASED ON THE SIZE OF THE SELECTED MICRUS MICROCOIL SYSTEM. NOTE: A CATHETER WITH A 0.017 INNER LUMEN WILL ACCEPT ALL SIZES OF THE MICRUS MICROCOILS. INSERT THE INFUSION MICROCATHETER INTO THE RHV CONNECTED TO THE GUIDING CATHETER HUB. ATTACH A SECOND RHV TO THE HUB OF THE INFUSION MICROCATHETER. CONNECT A ONE WAY VALVE STOPCOCK TO THE RHV¿S SIDEARM; AND ATTACH A FLUSH LINE. ADJUST THE HYDROSTATIC PRESSURE TO 300 MM OF HG AND MAINTAIN AN OPEN FLUSH THROUGHOUT THE PROCEDURE. CHECK TO ENSURE THAT ALL FITTINGS ARE SECURE AND THAT NO AIR IS BEING INTRODUCED INTO THE SYSTEM DURING ACTIVE FLUSHING. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, BASED ON THE ANALYSIS, THE EVIDENCE SUGGESTS THAT THE COIL¿S RESISTANCE INSIDE THE MICROCATHETER MAY HAVE BEEN DUE TO DETACHED DEBRIS. IN ADDITION; WITHOUT THE RETURN OF THE SL-10 MICROCATHETER USED IN THE PROCEDURE; IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. ADDITIONALLY, REVIEW OF THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS ARE TAKEN. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS - 21 CFR PART 803, MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER, THERE WAS RESISTANCE. SO THE COIL WAS REMOVED BEFORE DEPLOYMENT. PRODUCT ANALYSIS ON (B)(4) 2011 REVEALED THAT THE COIL WAS RETURNED SEVERELY DAMAGED. THE EVIDENCE SUGGESTS THE COILS RESISTANCE INSIDE THE MICROCATHETER MAY HAVE BEEN DUE TO DETACHED DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555130 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13972

    Patients

    Seq Age Sex Outcome Treatment
    1