BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 2953980 · Received February 11, 2013

    Report

    Report Number
    1226348-2013-20010
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. BASED ON THE LIMITED INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE FAILURE TO DETACH OR DETACHMENT OF THE COIL. THE EXACT CIRCUMSTANCES OF HOW THE COIL BECAME ANCHORED CANNOT BE DETERMINED AND IS SPECULATIVE. THE DPU PASSED FUNCTIONAL TESTING, AND THERE WAS EVIDENCE OF ENERGY DELIVERED TO THE FIBERS, CONFIRMED MELTING. BASED ON THE LACK INFORMATION, NO CONCLUSION CAN BE MADE REGARDING CONTRIBUTING FACTORS TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE PRESIDIO MICROCOIL (PC4100412-30/J10514) WOULD NOT DETACH USING AN UNSPECIFIED ENPOWER CABLE (CATALOGUE AND LOT UNKNOWN). IT WAS NOTED THAT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AT THE TIME THE DETACHMENT WAS ATTEMPTED. HOWEVER, AFTER THE PRESIDIO WAS REPLACED FOR A NEW ONE (LOT UNKNOWN), THE SYSTEM READY LIGHT ILLUMINATED AND THE COIL WAS DETACHED WITHOUT ANY PROBLEM. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY REPORTED. ACCORDING TO THE PHYSICIAN, PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE EXCELSIOR SL10 MICROCATHETER (STRYKER). IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE PROCEDURE WAS COIL EMBOLIZATION OF INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS NOT CALCIFIED AND MODERATELY TORTUOUS. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE COIL WAS RETURNED UNDAMAGED. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING. THE DETACHMENT FIBER FAILED TO RECEIVE HEAT AND MELT AS DESIGNED. IT IS IMPORTANT TO NOTE THAT THE DPU WAS RETURNED SEVERELY KINKED AND BENT IN MULTIPLE SECTIONS FROM POST-PROCEDURAL HANDLING. AS THE ELECTRICAL WIRING TRAVELS THROUGH THE INSIDE DIAMETER OF THE DPU'S HYPOTUBE, IT CANNOT BE EXACTLY DETERMINED TO WHICH EXTENT THIS DAMAGE OF SEVERE KINKING AND BENDING CONTRIBUTED TO THE FINAL ANALYSIS OF THIS DEVICE. IN ADDITION, THE RETURNED MICROCOIL SYSTEM WAS ALSO CLEANED BY THE END USER WHICH MAY HAVE HAD AN ADDITIONAL COMPROMISING EFFECT TO THE COPPER WIRING, THE SOLDER JOINT CONNECTIONS, AND THE RESISTIVE HEATING COIL SECTION. HOWEVER, ADDITIONAL TESTING FOUND THAT THE MOST LIKELY ROOT CAUSE OF THE COILS NON-DETACHMENT INSIDE THE ANEURYSM AND THE FAILURE OF THE ENPOWER SYSTEMS GO LIGHT FAILURE TO ILLUMINATE WERE DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL SECTION. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED. IN ADDITION WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. IT WAS STATED THAT THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED, FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, "VERIFY THE FUNCTIONALITY OF THE MICRUS MICROCOIL DELIVERY SYSTEM BEFORE PROCEEDING WITH MICROCOIL PLACEMENT. THIS NEEDS TO BE DONE WITH THE MICROCOIL STILL IN THE HOOP. TO VERIFY PROPER DCB AND MICROCOIL FUNCTIONALITY A CONNECTING CABLE AND MICROCOIL MUST BE CONNECTED TO THE DCB UNIT. AFTER VERIFICATION OF THE DCB AND CONNECTING CABLE, TURN OFF POWER TO THE DCB AND DISCONNECT THE CONNECTING CABLE FROM THE MICROCOIL UNTIL THE MICROCOIL IS READY TO BE DETACHED. PLEASE REFER TO THE DETACHMENT CONTROL BOX INSTRUCTIONS FOR USE SECTION, LOCATED NEAR THE END OF THIS DOCUMENT, BEFORE PROCEEDING." 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. BASED ON THE LIMITED INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE FAILURE TO DETACH OR DETACHMENT OF THE COIL. THE DPU DID NOT PASSED FUNCTIONAL TESTING, AND THERE WAS EVIDENCE OF ENERGY DELIVERED TO THE FIBERS, CONFIRMED MELTING. ADDITIONALLY, THE DAMAGES FOUND ON THE UNIT MAY HAVE OCCURRED DURING THE SHIPPING PROCESS, SINCE IT WAS REPORTED THAT THE DEVICE WAS NOT DAMAGED AFTER REMOVAL. BASED ON THE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING CONTRIBUTING FACTORS TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PRESIDIO MICROCOIL (PC4100412-30/J10514) WOULD NOT DETACH USING AN UNSPECIFIED ENPOWER CABLE (CATALOGUE AND LOT UNKNOWN). IT WAS NOTED THAT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AT THE TIME THE DETACHMENT WAS ATTEMPTED. HOWEVER, AFTER THE PRESIDIO WAS REPLACED FOR A NEW ONE (LOT UNKNOWN), THE SYSTEM READY LIGHT ILLUMINATED AND THE COIL WAS DETACHED WITHOUT ANY PROBLEM. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY REPORTED. ACCORDING TO THE PHYSICIAN, PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE EXCELSIOR SL10 MICROCATHETER (STRYKER). IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE PROCEDURE WAS COIL EMBOLIZATION OF INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS NOT CALCIFIED AND MODERATELY TORTUOUS. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58808 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA J10514

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CABLE AND DCB