BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 3811462 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-00107
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: EXCELSIOR SL 10/J XT27 FLEX; CONTROL BOX (BLACK, DETAILS UNKNOWN); ENPOWER CONTROL BOX (DCB00000500/C20654). THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. AS VIEWED THROUGH THE RETURNED PACKAGING IT WAS OBSERVED THAT THE COIL WAS RETURNED COMPLETELY UNSHEATHED, UNPROTECTED, AND DAMAGED. IT CANNOT BE DETERMINED HOW MUCH OF THE COIL WAS DAMAGED POST-PROCEDURALLY FROM HANDLING AND PACKAGING. LOCATED 13.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER AND ADJACENT TO THE DISTAL TIP OF THE SKIVE; THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH FOR THE REMAINDER OF ITS LENGTH. LOCATED AT THE PROTRUSION SITE IS MECHANICAL SHEATH DAMAGE CAUSED BY THE RESHEATHING TOOL THAT OPENED UP THE SKIVE ALLOWING THE CORE WIRE TO PROTRUDE OUTSIDE THE SHEATH. THE COIL¿S SOCKET RING HAS BEEN PUSHED DOWN INSIDE THE OUTER SHEATH. THE COIL HAS COMPRESSION AND BUCKLING DAMAGE THAT CAUSED A LOSS OF THE SECONDARY WINDING AT THE DISTAL SECTION. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN DAMAGED. THE LOCKING MECHANISM HAS COMPRESSION AND STRETCHING DAMAGE. IT IS POSSIBLE THAT THIS DAMAGE OCCURRED DURING UNSHEATHING/RESHEATHING IF THE SHEATH WAS RETRACTED STRAIGHT BACK INSTEAD OF AT A FORTY-FIVE DEGREE ANGLE AS OUTLINED IN THE IFU. HOWEVER, THIS FINDING WOULD LIKELY HAVE PRODUCED RESISTANCE DURING ADVANCEMENT THROUGH THE MICROCATHETER AND BASED ON THE CORE WIRE PROTRUSION OUT OF THE SHEATH, DOES NOT APPEAR TO HAVE OCCURRED DURING INITIAL INTRODUCTION, BUT MAY HAVE OCCURRED AFTER THE REPORTED EVENT DURING RETRACTION OR POST PROCEDURAL HANDLING. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING WITH RESISTANCE AT 0.0 OHMS AND THE ENPOWER SYSTEMS GO LIGHT FAILED TO ILLUMINATE. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS NON-DETACHMENT APPEARS TO HAVE BEEN DUE TO A FRACTURE AT THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL. THE INSTRUCTIONS FOR USE OUTLINES TO ¿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.¿ IT FURTHER OUTLINES STEPS TO TAKE IF THE DEVICE DOES NOT PASS THE PRE-DEPLOYMENT TEST. 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 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 REPORTED EVENT WAS CONFIRMED AND BASED ON THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE IT APPEARS TO BE DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTOR. BASED ON THE REPORTED INFORMATION AND WITHOUT THE USER HAVING DONE THE PRE-DEPLOYMENT CHECK AS OUTLINED IN THE INSTRUCTIONS FOR USE, THE TIMING AND ROOT CAUSE OF THE DAMAGE CANNOT BE DETERMINED. ALL DEVICES UNDERGO MULTIPLE ELECTRICAL CHECKS BEFORE REACHING THE FINAL PACKAGING. WITH REVIEW OF THE DEVICE HISTORY RECORDS AND ANALYSIS THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE STANDARD COILING PROCEDURE, HAVING THE COIL (CPL10040430/ G15531) DEPLOYED IN DESIRED POSITION, USING THE STANDARD DETACHMENT PROTOCOL REPEATEDLY, IT WAS NOT POSSIBLE TO DETACH THE COIL FROM DELIVERY WIRE. THE EXCELSIOR SL 10/J XT27 FLEX MICROCATHETER WAS USED TO DELIVER THE COIL. THE CUSTOMER WAS USER OF THE OLD CONTROL BOX (BLACK, DETAILS UNKNOWN) AND BY COINCIDENCE THE ENPOWER CONTROL BOX (DCB00000500/C20654) WAS DELIVERED TO HIM PRIOR THIS CASE AND THE TRAINING FOR IT WAS SCHEDULED BUT NOT PERFORMED AT THE TIME OF THE CASE. DURING THE CASE THEY ATTEMPTED TO DETACH THE COIL WITH THE OLD CONTROL BOX AND AS IT WAS NOT WORKING THEY TRIED TO USE THE ENPOWER CONTROL BOX WITHOUT ANY SUCCESS. THE COIL WAS SUCCESSFULLY REMOVED FROM THE ANEURYSM AND THE PROCEDURE WAS FINISHED WITHOUT ANY COMPLICATION. DURING THE TRAINING ON THE ENPOWER CONTROL BOX THE CODMAN TRAINERS PERFORMED ELECTRICAL CHECK OF THE EXPLANTED COIL AND IT SHOWED THAT CIRCUIT WAS BROKEN. IT IS UNKNOWN WHETHER THE CIRCUIT WAS BROKEN PRIOR TO THE PROCEDURE OR AFTER. THERE WAS NO DAMAGE TO THE COIL OR COIL DELIVERY SYSTEM PRIOR TO USE OR AFTER REMOVAL. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO RESISTANCE/FRICTION ADVANCING THE COIL THROUGH THE MICROCATHETER. OTHER COILS WERE SUCCESSFULLY DELIVERED USING THE SAME MICROCATHETER AFTER THE EVENT. NO TORQUING OF THE DPU WAS REQUIRED DURING POSITIONING OF THE COIL IN THE ANEURYSM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED ON EITHER DETACHMENT CONTROL BOX. LOW BATTERY LIGHTS WERE NOT SEEN DURING THE CASE AND NEW BATTERIES WERE USED IN THE BLACK CONTROL BOX. NO FAULT LIGHT WAS SEEN DURING THE CASE. ALL LIGHTS ILLUMINATED WHEN PRESSING THE POWER BUTTON ON THE ENPOWER CONTROL BOX. ALL CONNECTIONS APPEARED TO FIT CORRECTLY WITHOUT EXCESSIVE FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289962 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G15531

    Patients

    Seq Age Sex Outcome Treatment
    1