BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 2842994 · Received November 21, 2012

    Report

    Report Number
    2954740-2012-00791
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE, THE DELTAPLUSH CERECYTE MICROCOIL (CPL10020630/ G14609) WOULD NOT ADVANCE IN THE SL-10 MICROCATHETER (STRYKER) MIDDLE SECTION. THE COIL WAS REMOVED WITHOUT LOSING TARGET SITE, AND THE SAME MICROCATHETER WAS USED WITH THE NEXT DEVICE. A GUIDEWIRE WAS USED TO EXCHANGE THE MICROCATHETER AND MAINTAINED TARGET SITE. A DEDICATED AND CONSTANT SALINE SOURCE WAS UTILIZED AT ALL TIMES WITH THE MICROCATHETER. AFTER THE EVENT, IT WAS UNKNOWN IF ADDITIONAL FORCE, TORQUE OR MANIPULATION WAS USED TO FURTHER ADVANCE THE DEVICE. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE DEVICES (KINK, BEND, STRETCHED, FRACTURE, SEPARATE, STENT, COIL RING FRACTURE, ETC). THERE WAS NO ADVERSE EVENT AND THE COMPONENTS WILL BE RETURNED FOR ANALYSIS. THE PROXIMAL END OF THE COIL WAS RETURNED SEVERELY BUCKLED AND COMPRESSED. THE COIL'S SOCKET RING WAS SEVERED. THE FRACTURE WAS DUCTILE IN NATURE REQUIRING EXTERNAL FORCE. NO MATERIAL DEFECTS WERE FOUND TO THE SEVERED ENDS. THE SUTURE WAS STILL ATTACHED TO THE DETACHMENT FIBER. A SEVERE KINK WAS FOUND TO THE CORE WIRE PROXIMAL TO THE RESHEATHING TOOL. THE DISTAL SECTION OF THE COIL WAS UNDAMAGED. THE COIL HAD TO BE DISSECTED OUT OF THE SHEATH DUE TO A COMPLETE BLOCKAGE INSIDE THE DISTAL END OF THE GREEN INTRODUCER WHICH PREVENTED THE 0.014'' GUIDE WIRE FROM PASSING THROUGH. THE MAJORITY OF THE BLOCKAGE CONSISTED OF BLOOD AS CONTRAST AND PROTEIN WHERE NOT OBSERVED TO BE PRESENT IN A LARGE ENOUGH FORM TO BE IDENTIFIED. THE MOST LIKELY CONTRIBUTING FACTOR TO THE ROOT CAUSE OF THE COILS INABILITY TO BE ADVANCED INSIDE THE MICROCATHETER WAS DUE TO DISTAL INTERFERENCE. THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. IT ALSO CANNOT BE EXACTLY DETERMINED HOW THE COIL'S SOCKET RING WAS SEVERED. 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 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 DURING ANALYSIS, MAY HAVE OCCURRED DURING THE SHIPPING PROCESS, SINCE IT WAS REPORTED THAT AFTER REMOVAL FROM THE PATIENT, THE DEVICE WAS NOT DAMAGED. THE COMPLAINT COIL FAILURE TO DETACH WAS NOT CONFIRMED ON ANALYSIS DUE TO THE MULTIPLE DAMAGES FOUND DURING ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Additional Manufacturer Narrative · 1

    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 PRODUCT WILL BE RETURNED FOR ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE DELTAPLUSH CERECYTE MICROCOIL (CPL10020330/ (B)(4)) WOULD NOT DETACH, AND THEN ENTIRE MICROCOIL WAS PULLED BACK. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT STRETCHING, DAMAGE, AND THE COIL, REMAINED ATTACHED TO THE (DPU) DEVICE POSITIONING UNIT. AN ENPOWER DCB (BLUE) DETACHMENT CONTROL BOX WAS USED WITH A STANDARD CABLE. THE LOW BATTERY LIGHT WAS NOT SEEN DURING CASE. THE CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE, AND AFTER THE EVENT, OTHER COILS (NON-CODMAN) WERE USED TO COMPLETE THE PROCEDURE. NO RESISTANCE OCCURRED DURING INSERTION, ADVANCEMENT, POSITIONING, OR REMOVAL OF THE COIL DELIVERY SYSTEM, AND NO ATTEMPTS WERE MADE TO DETACH THE COIL MANUALLY. THE MICROCATHETER USED WAS A SL 10 MICROCATHETER. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE DEVICES (KINK, BEND, STRETCHED, FRACTURE, SEPARATE, STENT, COIL RING FRACTURE, ETC). THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE DELTAPLUSH CERECYTE MICROCOIL (CPL10020330/ G15250) WOULD NOT DETACH, AND THEN ENTIRE MICROCOIL WAS PULLED BACK. THERE WAS NO ADVERSE EVENT REPORTED AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G15250

    Patients

    Seq Age Sex Outcome Treatment
    1