BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 2913627 · Received January 14, 2013

    Report

    Report Number
    2954740-2013-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    April 19, 2012
    Report Date
    April 25, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SECTION OF THE COIL WAS RETURNED WITH SEVERE BUCKLING AND COMPRESSION DAMAGE. THE DISTAL TIP AND THE PROXIMAL END OF THE COIL HAD A COPIOUS AMOUNT OF SOLIDIFIED CONTRAST ADHERING TO THOSE SECTIONS. THE FIRST SECONDARY WINDING OFF THE BALL TIP WAS BENT AND TWISTED AWAY FROM THE REMAINING COIL WINDINGS. THE DEVICE POSITIONING UNIT (DPU) WAS FOUND PROTRUDING OUTSIDE THE SHEATH. A SECTION OF SEVERE MECHANICAL DAMAGE WAS FOUND TO THE SHEATH. THIS DAMAGE IS ASSOCIATED WITH THE RESHEATHING TOOL. THE RESHEATHING TOOL WAS FOUND TO HAVE BEEN SEVERED INTO TWO PIECES. THE FRACTURE IS DUCTILE IN NATURE REQUIRING EXTERNAL FORCE. NO MATERIAL DEFECTS WERE FOUND TO THE SEVERED ENDS. THIS DAMAGE IS MOST LIKELY RELATED TO THE SEVERE MECHANICAL DAMAGE FOUND TO THE SHEATH. A COMPLETE BLOCKAGE WAS FOUND IN THE RETURNED SL-10 MICROCATHETER. THIS BLOCKAGE WAS FOUND TO BE SOLIDIFIED CONTRAST. THE INNER LUMEN OF THE MICROCATHETER WAS FOUND TO HAVE OVALIZED. THERE ARE MULTIPLE POSSIBLE CONTRIBUTING FACTORS TO THE COIL S RESISTANCE INSIDE THE MICROCATHETER. THE PRIMARY AND MOST LIKELY CONTRIBUTING FACTOR TO THE COILS RESISTANCE INSIDE THE MICROCATHETER WAS MOSTLY LIKELY DUE TO DISTAL INTERFERENCE IN THE FORM OF A CONTRAST BLOCKAGE INSIDE THE PROXIMAL SECTION OF THE MICROCATHETER. THIS WOULD HAVE PRODUCED THE BUCKLING AND COMPRESSION TO THE COIL, THE PROTRUSION OF THE DPU OUTSIDE THE SHEATH, THE SEVERE MECHANICAL SHEATH DAMAGE AND THE FRACTURING OF THE RESHEATHING TOOL. IT IS IMPORTANT TO NOTE THAT TWO DIFFERENT CATALOG AND LOT NUMBERED MICROCOIL SYSTEM ENCOUNTERED THE SAME RESISTANCE INSIDE THE SAME MICROCATHETER. IF THE CONTRAST DID PRODUCE DISTAL INTERFERENCE THE 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. THE CONNECTIONS NECESSARY FOR THE MICRUS MICROCOIL DELIVERY SYSTEM INCLUDING A TYPICAL CONTINUOUS SALINE FLUSH SET UP WITH PRESSURE BAG FOR THE CATHETER SYSTEMS..." THE SECONDARY CONTRIBUTING FACTOR TO THE COILS RESISTANCE INSIDE THE MICROCATHETER MAY HAVE BEEN DUE TO THE OVALIZATION OF THE INNER LUMEN OF THE MICROCATHETER. THE COMPRESSED SIDES OF THE MICROCATHETER WOULD HAVE PRODUCED FRICTION AGAINST THE COIL'S DIAMETER DURING ADVANCEMENT. THE THIRD CONTRIBUTING FACTOR MAY HAVE BEEN THE SEVERE MECHANICAL SHEATH DAMAGE THAT MAY HAVE CAUSED THE DPU TO PROTRUDE OUTSIDE THE SHEATH. IN THIS CONDITION SIGNIFICANT RESISTANCE WILL BE ENCOUNTERED WHEN ATTEMPTING TO ADVANCE THE COIL INSIDE THE MICROCATHETER. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DAMAGES FOUND ON THE DEVICES, COULD NOT BE CONFIRMED, SINCE NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE LIMITED INFORMATION, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKING AT THIS TIME. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2013-00011 AND 2954740-2013-00012.

    Description of Event or Problem · 1

    DURING THE COILING PROCEDURE, RESISTANCE WAS REPORTED WHEN ADVANCING THE MICROCOILS (DELTAPLUSH CERECYTE MICROCOIL 1.5 MM X 1 CM-CPL10015130/G14040 AND DELTAPLUSH CERECYTE MICROCOIL 2 MM X 6 CM- CPL10020630/ G14610) THROUGH THE MICROCATHETER. ADDITIONALLY, THE DEVICES WERE RETURNED FOR ANALYSIS, AND BOTH DEVICES WERE RECEIVED FOR ANALYSIS, AND THE DELTAPLUSH CERECYTE MICROCOIL 1.5 MM X 1 CM-CPL10015130/G14040 HAD COIL DAMAGED AND DELTAPLUSH CERECYTE MICROCOIL 2 MM X 6 CM- CPL10020630/G14610 COIL WAS NOT RETURNED AND SEPARATION APPEARED MECHANICAL IN NATURE. AFTER THE EVENT, BOTH COILS WERE PULLED OUT FROM THE MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED, AND NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCTS WERE RETURNED FOR ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20188 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G14040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER