BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 4060176 · Received September 4, 2014

    Report

    Report Number
    1226348-2014-00339
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    February 12, 2011
    Report Date
    February 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

    (B)(6). COMPLAINT CONCLUSION: THE DEVICE WAS RETURNED FOR ANALYSIS. LOCATED OFF THE PROXIMAL END AT 38.0CM AND 90.5CM ARE TWO SEVERE KINKS ON THE CORE WIRE. THERE WAS SEVERE PROXIMAL COIL DAMAGE AND KNOTS IN THE COIL. COMPRESSION COIL DAMAGE ADJACENT TO THE DISTAL SOLDERED SECTION AND PROXIMAL COIL DAMAGE (BUCKLING, COMPRESSION, AND STRETCHING) WAS NOTED. THE DISTAL SECTION OF THE COIL WAS UNDAMAGED. THE COIL WAS RECEIVED ADVANCED OUTSIDE THE GREEN INTRODUCER SECTION OF THE DEVICE POSITIONING UNIT (DPU). NO DPU ADVANCEMENT WAS POSSIBLE IN THE STATE RECEIVED. THE PROXIMAL END OF THE COIL WAS RETURNED SEVERELY DAMAGED. IT IS NOT POSSIBLE TO DETERMINE THE AMOUNT OF DAMAGE THAT OCCURRED DURING THE PROCEDURE AND POST-PROCEDURE HANDLING. THE MOST LIKELY ROOT CAUSE OF THE RESISTANCE INSIDE THE MICROCATHETER WAS DUE TO INTERFERENCE. THE EVIDENCE SUGGESTS THAT A CONTRIBUTING FACTOR TO THE RESISTANCE MAY HAVE BEEN THE BLOOD; PROTEIN; AND CONTRAST BLOCKAGE FOUND AT THE DISTAL TIP OF THE GREEN INTRODUCER. 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. FOR PROPER DEVICE HYDRATION, 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. IF UNUSUAL FRICTION IS STILL NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY FLUSH LINES ARE OPEN AND PROPERLY PRESSURIZED. THEN SLOWLY WITHDRAW THE ENTIRE MICRUS MICROCOIL SYSTEM AND EXAMINE FOR DAMAGE. REPLACE IT WITH A NEW MICROCOIL SYSTEM. IF FRICTION STILL EXISTS; WITHDRAW AND EXAMINE THE DELIVERY CATHETER SYSTEM.¿ SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS EVENT, NO CORRECTIVE ACTION WAS 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

    THERE WAS RESISTANCE IN THE SL-10 MC WHEN THE DELTAPLUSH CERCYTE MICROCOIL WAS BEING ADVANCED, AND SEVERE COIL DAMAGE WAS FOUND DURING ANALYSIS. THERE WAS NO SERIOUS INJURY OR REQUIRED INTERVENTION AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540578 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G12597

    Patients

    Seq Age Sex Outcome Treatment
    1