BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 3832868 · Received May 27, 2014

    Report

    Report Number
    1226348-2014-00113
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: EXSCELSIOR SL 10 MICROCATHETER (DETAILS UNKNOWN); MICROVENTION VFC COIL (DETAILS UNKNOWN); ENPOWER DCB (DETAILS UNKNOWN). 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

    THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING. THE DETACHMENT FIBER PARTIALLY MELTED AND POOLED AROUND THE RESISTIVE HEATING COIL¿S SOCKET RING AND WAS FOUND STILL CONNECTED TO THE COIL¿S SOCKET RING. LOCATED BETWEEN THE TEN AND TWO O¿CLOCK POSITION IS A LARGE VOID ON THE ANGLE RING¿S DIAMETER. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN DAMAGED WITH THE DAMAGED EDGES ELEVATED ABOVE THE SURFACE PLANE. THE LOCKING MECHANISM HAS COMPRESSION AND STRETCHING DAMAGE. IT IS POSSIBLE THAT THE COIL¿S SOCKET RING WAS PUSHED DOWN INSIDE THE ANGLE RING SECTION OF THE OUTER SHEATH AS IT IS IN THE DETACHMENT FIBERS LINE OF DIRECTION. A SECTION OF PARTIALLY MELTED DETACHMENT FIBER WAS FOUND ADHERING TO THE COIL¿S SOCKET RING. THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS NON-DETACHMENT INSIDE THE ANEURYSM MAY HAVE BEEN DUE TO A LOSS OF DETACHMENT FIBER TENSION WHICH ALLOWED A PORTION OF THE FIBER TO LOSE CONTACT WITH THE RESISTIVE HEATING COIL SURFACE. THIS CONDITION MAY HAVE PRODUCED A PARTIAL MELTING OF THE DETACHMENT FIBER WHICH STILL ADHERED TO THE COIL¿S SOCKET RING. IN THIS CONDITION THE DETACHMENT FIBER WOULD NOT HAVE FULLY RECEIVED HEAT AND WOULD HAVE NOT MELTED AS DESIGNED. THE LOSS OF FIBER TENSION CAUSED BY THE POSSIBLE INSERTION OF THE COIL¿S SOCKET RING DOWN INSIDE THE OUTER SHEATH MAY HAVE OCCURRED WHEN THE MICROCOIL SYSTEM WAS FIRST UNLOCKED FOR USE AND THE SHEATH WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK. WHEN THE SHEATH WAS PULLED STRAIGHT BACK, THE LOCKING MECHANISM CAUGHT THE INSIDE OF THE V NOTCH OF THE RESHEATHING TOOL AND BECAME EMBEDDED. IN ADDITION, THE LOCKING MECHANISM MAY NOT HAVE BEEN FULLY DISENGAGED OFF THE CORE WIRE. THE SHEATH ALSO CAUGHT THE V NOTCHES EXTENDED EDGES RAISING THEM ABOVE THE SURFACE PLANE. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE WHICH COULD HAVE PUSHED THE COIL¿S SOCKET RING UNDER THE OUTER SHEATH WHICH MAY HAVE CAUSED THE DETACHMENT FIBER TO STRETCH, MOVE AWAY FROM THE HEATING SURFACE, AND LOSE FIBER TENSION. IN THIS CONDITION A PARTIAL MELTING OF THE DETACHMENT FIBER MAY HAVE OCCURRED WHILE STILL ADHERING TO THE COIL¿S SOCKET RING CAUSING THE FAILURE TO DETACH INSIDE THE ANEURYSM. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿HOLD THE INTRODUCER SHEATH (LOOSELY-LOOPED) IN THE LEFT HAND. KEEPING THE INTRODUCER TIP NEAR THE RE-SHEATHING TOOL, GRASP THE DISTAL END OF THE RE-SHEATHING TOOL BETWEEN YOUR LEFT THUMB AND FOREFINGER. GRASP THE CLEAR TAB NEAR THE END OF THE INTRODUCER SHEATH BODY WITH THE THUMB AND FOREFINGER OF YOUR OTHER HAND. GENTLY PULL THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE SHEATHING TOOL AT A 45-DEGREE ANGLE TO UNLOCK THE MICROCOIL. CONTINUE TO PULL THE TAB UNTIL AN ADDITIONAL 0.5 TO 1.0 INCHES (1.3 TO 2.5 CM) OF THE TRANSLUCENT MATERIAL IS EXPOSED. GENTLY FOLD THE TRANSLUCENT TAB TOWARDS THE DISTAL END, AND FIRMLY GRASP THE DISTAL END OF THE RE SHEATHING TOOL AND THE TRANSLUCENT TAB BETWEEN YOUR THUMB AND FOREFINGER, AS SHOWN IN FIGURE 3¿¿ CAUTION: IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1IN. (2-3CM).¿ IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE, BUT UNIDENTIFIED 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. 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 INFORMATION AND THE ANALYSIS, THE EVENT WAS CONFIRMED, HOWEVER PROCEDURAL FACTORS OUTLINED IN THE IFU MAY HAVE ALSO CONTRIBUTED TO THE EVENT. WITHOUT RETURN OF CONCOMITANT PRODUCTS IT CANNOT BE DETERMINED IF THOSE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. 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

    REGARDING THE ADDITIONAL 20 MINUTES TAKEN TO COMPLETE THE SURGERY THERE IS NO INDICATION THAT HIS WAS A CLINICALLY SIGNIFICANT DELAY AND THERE WAS NO PATIENT INJURY REPORTED DUE TO THE PROCEDURE.

    Description of Event or Problem · 1

    THE PRESIDIO COIL (PC410051730/C20937) DID NOT DETACH AFTER DETACHMENT WAS ATTEMPTED A NUMBER OF TIMES AFTER IT WAS SUCCESSFULLY ADVANCED THROUGH AN EXCELSIOR SL10 MICROCATHETER (DETAILS UNKNOWN) AND PLACED IN THE ANEURYSM THAT ALREADY CONTAINED TWO COILS. THE COIL WAS REMOVED FROM THE ANEURYSM WITHOUT ANY ISSUES AND WAS STILL ATTACHED TO THE DEVICE POSITIONING UNIT (DPU). THE TIME TAKEN TO COMPLETE THE SURGERY WAS EXTENDED BY APPROXIMATELY 20 MINUTES. THERE WAS NO DAMAGE TO THE COIL OR COIL DELIVERY SYSTEM PRIOR TO USE OR AFTER REMOVAL. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. OTHER COILS (MICROVENTION VFC, DETAILS UNKNOWN) WERE SUCCESSFULLY DELIVERED AND DETACHED USING THE SAME MICROCATHETER AFTER THE EVENT. THE DPU DID NOT NEED TO BE TORQUED DURING POSITIONING OF THE COIL IN THE ANEURYSM. THE ENPOWER (DETAILS UNKNOWN) DETACHMENT CONTROL BOX WAS USED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. A LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE. NO FAULT LIGHT WAS SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTED ILLUMINATED. DURING THE DETACHMENT CYCLE THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE WAS USED SUCCESSFULLY WITH PRIOR COILS AND THE SAME DCB WAS USED WITH SUBSEQUENT COILS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310807 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C20937

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR