CASHMERE 14 - CERECYTE MICROCOIL
Report
- Report Number
- 1226348-2013-20123
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 13, 2013
- Manufacturer
- MICRUS ENDOVASCULAR, LLC
- Product Code
- HCG
- PMA / PMN Number
- K072173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
COMPLAINT CONCLUSION: DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID-ANTERIOR CHOROIDAL ARTERY ANEURYSM (VESSEL MODERATELY TORTUOUS), IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH THE CASHMERE (CRC140303-30/C11778, COMPLAINT PRODUCT) ALTHOUGH PRESSING THE DETACHMENT BUTTON. AFTER AN INTERVAL OF ABOUT 30 SECONDS, PHYSICIAN ATTEMPTED THE DETACHMENT AGAIN BUT THE SITUATION DID NOT CHANGE. THE GREEN SYSTEM READY LIGHT ILLUMINATED AT THAT TIME. THE PHYSICIAN TRIED TO DETACH IT A THIRD TIME, BUT IT STILL DID NOT DETACH. THEN, THE PHYSICIAN PUSHED THE DPU TO REPOSITION THE MARKER OF THE CASHMERE ALIGN WITH THE PROXIMAL MARKER OF THE UNSPECIFIED MICROCATHETER(HEADWAY17/TERUMO, TYPE UNKNOWN); HOWEVER, IT COULD NOT BE ADVANCED. ACCORDING TO THE PHYSICIAN, THE CASHMERE MICROCOIL MAY HAVE BECOME SEPARATED FROM THE DPU OR DETACHED UNINTENTIONALLY WITHIN THE MICROCATHETER. IT IS UNKNOWN WHEN AND HOW THIS OCCURRED; HOWEVER, IT WAS REPORTED THAT THE ENTIRE MICROCOIL BECAME DETACHED/SEPARATED FROM THE DELIVERY SYSTEM. SHORTLY AFTERWARD, THE MICROCATHETER LOST TARGET LESION AND ONE LOOP OF THE CASHMERE COIL PROTRUDED INTO THE MIDDLE CEREBRAL ARTERY (PARENT VESSEL) AND THE REST OF THE COIL REMAINED IN THE MICROCATHETER. THE MICROCOIL WAS SAFELY RETRIEVED FROM THE PATIENT BY USING A GOOSENECK SNARE WITHOUT REMOVING THE MICROCATHETER AND COIL SYSTEM FROM TARGET SITE. THERE WAS NO REPORT OF BREAKING, SEPARATION, STRETCHING, OR ANY OTHER DAMAGE TO THE COIL DELIVERY SYSTEM. THE PROCEDURE WAS CONTINUED USING A NEW PRODUCT (DETAILS UNKNOWN) WHICH WAS DELIVERED THROUGH THE SAME MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. IT IS UNKNOWN HOW MANY COILS WERE PLACED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN WHAT TYPE OF DCB AND CABLE WERE USED. ALL CONNECTIONS SEEMED TO FIT PERFECTLY. IT IS UNKNOWN IF SAME DCB AND CABLE WAS USED WITH SUBSEQUENT COILS. THE COMPLAINT PRODUCT WAS NEW AND 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 DEFECTS (KINK, BENDS ETC) WERE NOTED ON THE PRODUCT BY VISUAL INSPECTION. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES NOTED. THERE WAS NO RESISTANCE/FRICTION DURING ADVANCEMENT OF COIL SYSTEM THROUGH THE MICROCATHETER. PRIOR TO THIS COIL, OTHER COILS WENT THROUGH THE SAME MICROCATHETER SUCCESSFULLY. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. A ONE TO ONE RELATIONSHIP WAS VERIFIED PRIOR TO REPOSITIONING. COIL ENTANGLEMENT WITH PREVIOUSLY PACED COIL WAS NOT SUSPECTED IN THIS CASE. THERE WAS NO FLOW RESTRICTION/REDUCTION AS A RESULT. THERE WAS NO DAMAGE NOTED ON THE COIL SYSTEM, BOX, OR CABLE AFTER REMOVAL. NO ADDITIONAL INFORMATION IS AVAILABLE. THE COIL WAS RETURNED SEPARATED FROM THE DETACHMENT FIBER WITH PROXIMAL COIL DAMAGE MOST LIKELY DUE TO THE SNARE REMOVING THE COIL FROM THE MICROCATHETER. THE CORE WIRE HAS MULTIPLE BENT AND KINKED SECTIONS AT THE DISTAL SECTION OF THE DEVICE POSITIONING UNIT (DPU). THE DETACHMENT FIBER WAS FOUND TO BE PARTIALLY MELTED AND EXTENDED ABOVE THE DISTAL TIP OF THE DPU. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN FRACTURED. A SEVERED STRAND OF THE SHEATH IS OBSERVED TO BE PROTRUDING OUTSIDE THE FRACTURE. THE LOCKING MECHANISM HAS BEEN DAMAGED WITH COMPRESSION AND THE STRETCHING OF THE SHEATH MATERIAL OFF THE SURFACE PLANE. THE DPU PASSED ELECTRICAL TESTING WITH RESISTANCE AT 55.8 OHMS, AND THE ENPOWER SYSTEMS ¿GO¿ GREEN LIGHT ILLUMINATED. THERE ARE THREE POSSIBLE CONTRIBUTING FACTORS TO THE DPU PASSING THE PRE-DEPLOYMENT ELECTRICAL CHECK, FOLLOWED BY THE COIL¿S FAILURE TO DETACH INSIDE THE ANEURYSM, AND THE COIL¿S UNINTENDED DETACHMENT INSIDE THE MICROCATHETER DURING REMOVAL. THESE THREE CONTRIBUTING FACTORS MAY HAVE WORKED IN TANDEM OR SEPARATELY PRODUCING SIMILAR RESULTS. THE PRIMARY CONTRIBUTING FACTOR 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 DID CATCH 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. 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 CAUSED THE DETACHMENT FIBER AT THE ARTICULATING JUNCTION OF THE COIL¿S SOCKET RING TO LOSE FIBER TENSION WHICH WOULD HAVE CAUSED A LOSS OF CONTACT BETWEEN THE HEATING SURFACE AND THE DETACHMENT FIBER. THIS MAY HAVE RESULTED IN THE PARTIAL MELTING OF THE DETACHMENT FIBER CAUSING IT TO EXTENT ABOVE THE DISTAL TIP OF THE DPU. THE EXTENDED AND PARTIALLY MELTED DETACHMENT FIBER MOST LIKELY TEMPORARILY ADHERED TO OR CAUGHT THE COIL¿S SOCKET OR SUTURE. THIS WOULD HAVE RESULTED IN THE FAILURE TO DETACH INSIDE THE ANEURYSM AND THE EVENTUAL UNINTENDED DETACHMENT INSIDE THE MICROCATHETER DURING REMOVAL. 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 RETURNED OF THE UNIDENTIFIED COMPLETE DETACHMENT SYSTEM USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAIN T EVENT. THE SECOND CONTRIBUTING FACTOR MAY HAVE BEEN DISTAL INTERFERENCE. THIS INTERFERENCE MAY HAVE CAUSED THE DETACHMENT FIBER TO LOSE FIBER TENSION PRIOR TO ENTERING THE ANEURYSM. THOUGH IT WAS REPORTED THAT THE VESSEL WAS MODERATELY TORTUOUS, BECAUSE THE MICROCATHETER WAS NOT RETURNED THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE FULLY DETERMINED. WITHOUT THE RETURN OF THE HEADWAY MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. THE THIRD CONTRIBUTING FACTOR MAY HAVE OCCURRED DURING REPOSITIONING OF THE COIL INSIDE THE ANEURYSM. THE FILLER COIL MAY HAVE BECOME TEMPORARILY ANCHORED TO THE COILS ALREADY PLACED INSIDE THE ANEURYSM, ON THE COIL ITSELF, OR ON THE DISTAL TIP OF THE MICROCATHETER. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿CAUTION: IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM.CAUTION: IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER.¿ 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. NO CONCLUSION CAN BE DEFINITIVELY DRAWN WITH REGARD TO WHETHER ONE OR MORE OF THE THREE 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.
IT IS UNKNOWN HOW MANY COILS WERE PLACED DURING THE PROCEDURE. THE COMPLAINT PRODUCT WAS NEW AND 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. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES NOTED. THERE WAS NO RESISTANCE/FRICTION DURING ADVANCEMENT OF COIL SYSTEM THROUGH THE MC. PRIOR TO THIS COIL OTHER COILS WENT THROUGH THE SAME MC SUCCESSFULLY. THE MC WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MC. A ONE TO ONE RELATIONSHIP WAS VERIFIED PRIOR TO REPOSITIONING. COIL ENTANGLEMENT WITH PREVIOUSLY PACED COIL WAS NOT SUSPECTED IN THIS CASE. THERE WAS NO FLOW RESTRICTION/REDUCTION AS A RESULT. THERE WERE NO DAMAGES NOTED ON COIL SYSTEM, BOX, OR CABLE AFTER REMOVAL. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. THE MICROCOIL OF THE COMPLAINT PRODUCT WILL BE ALSO RETURNED WITH THE DPU. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 EVALUATION IS ANTICIPATED BUT HAS NOT BEGUN YET THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING THE COIL EMBOLIZATION OF INTERNAL CAROTID-ANTERIOR CHOROIDAL ARTERY ANEURYSM (VESSEL- MODERATELY TORTUOUS), IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH THE CASHMERE(CRC140303-30/C11778, COMPLAINT PRODUCT) ALTHOUGH PRESSING THE DETACHMENT BUTTON. AFTER INTERVAL OF ABOUT 30 SECONDS, PHYSICIAN ATTEMPTED THE DETACHMENT AGAIN BUT THE SITUATION WAS SAME. THE GREEN SYSTEM READY LIGHT ILLUMINATED AT THAT TIME. ONCE AGAIN, PHYSICIAN TRIED TO DETACH IT, BUT IT DIDN¿T DETACH. THEN, PHYSICIAN PUSHED THE DPU TO REPOSITION THE MARKER OF THE CASHMERE WITH THE PROXIMAL MARKER OF THE UNSPECIFIED MICROCATHETER(HEADWAY17/TERUMO, TYPE UNKNOWN), IT COULD NOT BE ADVANCED. ACCORDING TO THE PHYSICIAN, THE MICROCOIL OF THE CASHMERE MIGHT HAVE BEEN SEPARATED FROM THE DPU OR DETACHED UNINTENTIONALLY WITHIN THE MICROCATHETER. IT IS UNKNOWN WHEN AND HOW IT OCCURRED; HOWEVER IT WAS REPORTED THAT THE ENTIRE MICROCOIL GOT DETACHED/SEPARATED FROM THE DELIVERY SYSTEM. SHORTLY AFTER, THE MICROCATHETER LOST TARGET LESION AND THE ONE LOOP OF THE CASHMERE ACCIDENTALLY PROTRUDED INTO THE MIDDLE CEREBRAL ARTERY. IT WAS FURTHER EXPLAINED AS AFTER ENTIRE COIL GOT SEPARATED FROM THE SYSTEM, ONE LOOP OF THE COIL MOVED INTO THE PARENT VESSEL AND THE REST OF THE COIL REMAINED IN THE MC. THEREFORE THE MICROCOIL WAS SAFELY RETRIEVED FROM THE PATIENT BY USING A GOOSENECK SNARE. IT WAS ADDED THAT THE COIL WAS REMOVED FIRST USING A SNARE WITHOUT REMOVING MC AND COIL SYSTEM FROM TARGET SITE. NO REPORT OF BREAKING, SEPARATION, STRETCHING, OR ANY OTHER DAMAGES TO THE COIL DELIVERY SYSTEM. THE PROCEDURE WAS CONTINUED USING A NEW PRODUCT(DETAILS UNKNOWN) WHICH WAS MADE ALL WAY THROUGH THE SAME MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN WHAT TYPE OF DCB AND CABLE WAS USED. ALL CONNECTIONS SEEMED TO BE PERFECTLY FIT. IT IS UNKNOWN IF SAME DCB AND CABLE WAS USED WITH SUBSEQUENT COILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309255 | CASHMERE 14 - CERECYTE MICROCOIL | CNV DCS COILS | HCG | MICRUS ENDOVASCULAR, LLC | NA | C11778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |