BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 3950388 · Received July 22, 2014

    Report

    Report Number
    1226348-2014-00159
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS EMBOLIZATION OF INTRACRANIAL ANEURYSM WITH SIZE 5*4.7MM. WHEN THE SURGEON POSITIONED THE PRESIDIO 10 CERECYTE MICROCOIL 4 MM X 11.5 CM (PC410041230/C14983, IT COULD NOT BE DETACHED. THE SURGEON TRIED SEVERAL TIMES BUT STILL FAILED. CHANGED TO ANOTHER COIL (DETAILS UNKNOWN) TO COMPLETE. NO ADVERSE EVENT OCCURRED. LOCATED 16.0 CENTIMETERS OFF THE PROXIMAL END IS A KINK ON THE CORE WIRE. THE ELECTRICAL WIRING WAS NOT DAMAGED AT THE KINKED CORE WIRE. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING WITH RESISTANCE AT 0.0 OHMS AND THE ENPOWER SYSTEMS GO GREEN LIGHT FAILED TO ILLUMINATE. ADDITIONAL RESISTANCE TESTING STILL FOUND FAILURE READINGS FLOATING >29.44 M OHMS. COMPRESSION PERFORMED ON THE DISTAL SECTION OF THE RESISTIVE HEATING COIL BROUGHT THE RESISTANCE READING INTO A PASSING READING OF 50.5 OHMS. THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS INABILITY TO BE DETACHED INSIDE THE ANEURYSM WAS DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED AS ALL MICROCOIL SYSTEMS ARE ELECTRICALLY TESTED PRIOR TO FINAL PACKAGING. HOWEVER, IT WAS NOT REPORTED IN THE EVENT DESCRIPTION THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. IF A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED PRIOR TO USE, THEN FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿, ¿VERIFY THE FUNCTIONALITY OF THE 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...¿ IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE UNIDENTIFIED MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT WAS CONFIRMED, HOWEVER THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED. 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 WILL BE TAKEN AT THIS TIME.

    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, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS EMBOLIZATION OF INTRACRANIAL ANEURYSM WITH SIZE 5*4.7MM. WHEN THE SURGEON POSITIONED THE PRESIDIO 10 CERECYTE MICROCOIL 4 MM X 11.5 CM (PC410041230/C14983, IT COULD NOT BE DETACHED. THE SURGEON TRIED SEVERAL TIMES BUT STILL FAILED. CHANGED TO ANOTHER COIL (DETAILS UNKNOWN) TO COMPLETE. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428322 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C14983

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NEW COIL (DETAILS UNKNOWN)