BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 3223161 · Received July 12, 2013

    Report

    Report Number
    1226348-2013-20126
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DETACHMENT BOX (DETAILS UNKNOWN); NEW CABLE (DETAILS UNKNOWN); CLASSIC CONNECTING CABLE (CCB00015700/(B)(4)).

    Additional Manufacturer Narrative · 1

    DURING A COILING PROCEDURE OF A VESSEL OF UNKNOWN LOCATION AND CHARACTERISTICS, THE CASHMERE 14 PLATINUM MICROCOIL 8 MM X 20 CM (SRC14082020/C14429) FAILED TO DETACH USING A CLASSIC CONNECTING CABLE (CCB00015700/C13919). THE DETACHMENT CONTROL BOX EMITTED THE DETACHMENT SIGNAL; HOWEVER, THE COIL DID NOT DETACH. THIS SCENARIO WAS REPEATED ABOUT 4 TIMES. AFTER THE FIFTH DETACHMENT ATTEMPT THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL FROM THE ANEURYSM AND IT UNINTENTIONALLY DETACHED OUTSIDE THE ANEURYSM SAC. THE COIL WAS SUCCESSFULLY INSERTED INTO THE ANEURYSM WITH THE COIL INTRODUCER. AFTER THAT, OTHER COILS WERE SUCCESSFULLY PLACED USING ANOTHER CABLE. THERE WAS NO DAMAGE NOTED ON THE COIL AND CONNECTING CABLE PRIOR TO AND AFTER USE. THERE WAS NO RESISTANCE/FRICTION DURING DEPLOYMENT OF THE COIL SYSTEM THROUGH THE PROWLER SELECT MICROCATHETER (606S155MX/15756719). OTHER COILS WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER AFTER THE EVENT. THERE WAS NO TORQUING OF THE DPU REQUIRED DURING POSITIONING OF THE COIL IN THE ANEURYSM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED. THE PROCEDURE WAS PROLONGED 10 MINUTES AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE. NO INJURY TO THE PATIENT OCCURRED AS A RESULT OF THE EVENT. THE COIL WAS IMPLANTED. LABORATORY ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED. LOCATED 3MM OFF THE DISTAL TIP OF THE DEVICE POSITIONING UNIT (DPU) IS A BENT SECTION RESULTING IN A 55 DEGREE ANGLE. THE DISTAL DIAMETER HAS A GAP OR VOID FROM THE 4 O¿CLOCK TO 10 O¿CLOCK POSITION. LOCATED OFF THE RESISTIVE HEATING COIL¿S SOCKET RING, A PORTION OF THE MELTED DETACHMENT FIBER IS VISIBLE BETWEEN THE 10 O¿CLOCK TO 1 O¿CLOCK POSITION. VISUAL EXAMINATION SHOWS A PORTION OF THE MELTED DETACHMENT FIBER POOLING ON ONE SIDE OF THE RESISTIVE HEATING COIL¿S SOCKET RING. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN FRACTURED AND THE SURROUNDING EDGES HAVE BEEN RAISED ABOVE THE SURFACE PLANE. THE LOCKING MECHANISM SECTION HAS BEEN DAMAGED. THE DPU PASSED ELECTRICAL TESTING, WHICH INCLUDES RESISTANCE AT 52.6 OHMS, AND THE ENPOWER SYSTEM (DETACHMENT CONTROL BOX) ¿GO¿ (GREEN) LIGHT ILLUMINATED. THE RETURNED CABLE FROM THE PROCEDURE PASSED ELECTRICAL AND FUNCTIONALITY TESTING, WHICH INCLUDED DETACHING TEN IN-HOUSE TEST COILS WITH NO PROBLEMS ENCOUNTERED. WHEN THE RETURNED CONNECTING CABLE WAS CONNECTED TO THE RETURNED DPU, THE ENPOWER SYSTEM¿S ¿GO¿ LIGHT ILLUMINATED. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE CONNECTING CABLE UTILIZED IN THE PROCEDURE CONTRIBUTED TO THE FIELD COMPLAINT. THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE COIL¿S NON-DETACHMENT INSIDE THE ANEURYSM AND ITS UNINTENDED DETACHMENT DURING REMOVAL INSIDE THE PROWLER SELECT MICROCATHETER. THIS MAY HAVE BEEN DUE TO LOSS OF TENSION IN THE DETACHMENT FIBER PRIOR TO THE DETACHMENT ATTEMPTS INSIDE THE ANEURYSM. A PRIMARY CONTRIBUTING FACTOR TO THIS LOSS OF TENSION 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. ADDITIONAL SHEATH CONTACT CAUSED THE EXTENDED EDGES OF THE V NOTCH TO BE RAISED ABOVE THE SURFACE PLANE. IN ADDITION, THE LOCKING MECHANISM MAY NOT HAVE BEEN FULLY DISENGAGED OFF THE CORE WIRE. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE WHICH MAY HAVE CONTRIBUTED TO THE DETACHMENT FIBER¿S LOSS OF TENSION. THIS LOSS OF TENSION IN TURN MAY HAVE CAUSED THE DETACHMENT FIBER TO HAVE LOST SOME CONTACT AGAINST THE ADJACENT HEATING SURFACE OF THE DISTAL SECTION OF THE RESISTIVE HEATING COIL, THEREBY CAUSING THE MELTING DETACHMENT FIBER TO POOL AROUND AND/OR EXTEND ABOVE THE RESISTIVE HEATING COIL¿S SOCKET RING. THE MELTING DETACHMENT FIBER MAY HAVE TEMPORARILY CAPTURED THE COIL BY ADHERING TO THE COIL¿S SOCKET RING AND/OR THE SUTURE. WHEN THE COIL WAS BEING RETRACTED FOR REMOVAL THERE WAS THEN AN UNINTENDED COIL DETACHMENT INSIDE THE MICROCATHETER. 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).¿ WITHOUT THE RETURN OF THE UNIDENTIFIED DETACHMENT CONTROL BOX (DCB) AND THE COIL USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, IT IS UNLIKELY THAT FUNCTIONALITY OF THE DCB WAS AN ISSUE BECAUSE THE SAME DCB WAS REPORTED TO HAVE BEEN USED TO DETACH SUBSEQUENT COILS DURING THE PROCEDURE. THE SECONDARY CONTRIBUTING FACTOR TO THE DETACHMENT FIBER LOSS OF TENSION MAY HAVE BEEN DUE TO DISTAL INTERFERENCE INSIDE THE MICROCATHETER AND/OR DURING THE POSITIONING OF THE COIL INSIDE THE ANEURYSM, DURING WHICH IT MAY HAVE BECOME TEMPORARILY ANCHORED. AS PREVIOUSLY NOTED, THE DISTAL SECTION OF THE DPU WAS BENT AT APPROXIMATELY 55 DEGREES LEAVING A LARGE VOID AT THE DISTAL DIAMETER OF THE ANGLE RING SECTION OF THE OUTER SHEATH. THE BENDING AND THE OPENED VOID ALSO MAY HAVE ALLOWED THE DETACHMENT FIBER TO LOSE FIBER TENSION ON THE OPENED SIDE OF THE DISTAL DIAMETER AND TO THEN MOVE AWAY FROM THE HEATING SURFACE. THIS MAY HAVE ALLOWED THE MELTING DETACHMENT FIBER TO POOL AND/OR EXTEND ABOVE THE RESISTIVE HEATING COIL. THIS CONDITION MAY HAVE ALLOWED THE MELTING DETACHMENT FIBER TO TEMPORARILY CAPTURE THE COIL BY ADHERING TO THE COIL¿S SOCKET RING OR TO THE SUTURE. WHEN THE COIL WAS RETRACTED FOR REMOVAL THE COIL THEN DETACHED INSIDE THE MICROCATHETER. THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. WITHOUT THE IDENTIFICATION OR THE RETURN OF THE PROWLER SELECT MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS NO RESISTANCE FELT AND THE SAME PROWLER MICROCATHETER WAS USED SUCCESSFULLY WITH OTHER COILS AFTER THE EVENT. THEREFORE, IT SEEMS UNLIKELY THAT THE MICROCATHETER ITSELF WAS AN ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS COIL LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NO CONCLUSION CAN BE DEFINITIVELY DRAWN WITH REGARD TO WHETHER ONE OR BOTH POSSIBLE CONTRIBUTING FACTORS IDENTIFIED IN THE ANALYSIS CONTRIBUTED TO THE COMPLAINT EVENT, AND THE LABELING APPEARS TO ADEQUATELY ADDRESS THESE FACTORS. THEREFORE, BASED ON THE FOREGOING ANALYSIS, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CASHMERE 14 PLATINUM MICROCOIL 8 MM X 20 CM (SRC14082020/(B)(4)) WASN'T DETACHED USING A CLASSIC CONNECTING CABLE (CCB00015700/(B)(4)). THE DETACHMENT BOX MADE THE DETACHMENT SIGNAL BUT THE COIL WASN'T DETACHED. THIS SCENARIO WAS REPEATED ABOUT 4 TIMES. DURING THE FIFTH ATTEMPT THE PHYSICIAN WANTED TO RETRIEVE THE COIL FROM THE ANEURYSM AND IT DETACHED BY ITSELF OUT OF THE ANEURYSM SAC. THE COIL WAS SUCCESSFULLY INSERTED INTO THE ANEURYSM WITH THE COIL INTRODUCER. THE PROCEDURE WAS PROLONGED 10 MINUTES AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE DEVICE. NO INJURY OCCURRED AS A RESULT OF THE EVENT. AFTER THAT, OTHER COILS WERE SUCCESSFULLY PLACED USING ANOTHER CABLE. THERE WERE NO DAMAGES NOTED ON THE COIL AND CONNECTING CABLE PRIOR TO AND AFTER USE. THERE WAS NO RESISTANCE/FRICTION DURING DEPLOYMENT OF THE COIL SYSTEM THROUGH THE MICROCATHETER (606S155MX/(B)(4)). OTHER COILS WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER AFTER THE EVENT. THERE WAS NO TORQUING OF THE DPU REQUIRED DURING POSITIONING OF THE COIL IN THE ANEURYSM. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324080 CASHMERE 14 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C14429

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR