DELTAPAQ - CERECYTE MICROCOIL
Report
- Report Number
- 1226348-2013-20141
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- July 1, 2013
- Report Date
- July 5, 2013
- Manufacturer
- MICRUS ENDOVASCULAR, LLC
- Product Code
- HCG
- PMA / PMN Number
- K080437
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
UPDATED TO INCLUDE NEW INFORMATION RECEIVED 9/8/2013. DURING COIL EMBOLIZATION OF AN OPHTHALMIC ARTERY ANEURYSM OF SIZE 3.56 X 4.35 MM IN A (B)(6 YR OLD MALE PATIENT, THE FINAL COIL, A DELTAPAQ CERECYTE MICROCOIL 1.5 MM X 6 CM (CDF10015630/M10204), COULD NOT BE DETACHED FROM THE DELIVERY SYSTEM AFTER THE GUIDE WIRE WAS WITHDRAWN. THE PHYSICIAN ATTEMPTED TO DETACH A SECOND TIME BUT IT STILL FAILED. HE THEN WITHDREW THE COIL AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT TO THE PATIENT IS REPORTED TO HAVE OCCURRED. THERE WAS NO DAMAGE NOTED ON THE COIL EITHER PRIOR TO OR AFTER USE. THE SAME UNKNOWN MICROCATHETER WAS USED FOR THE ENTIRE PROCEDURE, AND THERE WAS NO RESISTANCE/FRICTION NOTED DURING ADVANCEMENT THROUGH THE MICROCATHETER. THE WAS NO TORQUING OF THE DEVICE POSITIONING UNIT (DPU) DURING POSITIONING OF THE COIL IN THE ANEURYSM. IT IS UNKNOWN IF THE SAME UNKNOWN DETACHMENT CONTROL BOX WAS USED FOR THE ENTIRE PROCEDURE. THE SAME UNKNOWN CONNECTING CABLE WAS USED FOR THE ENTIRE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. IT IS UNKNOWN IF THE LOW BATTERY LIGHT AND FAULT LIGHT WERE SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED, INCLUDING THE GREEN SYSTEM READY LIGHT. THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. ONLY THE COIL AND THE DPU WERE RETURNED FOR LABORATORY ANALYSIS. THE COIL WAS RETURNED UNDAMAGED. LOCATED 12.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH UNTIL ENTERING THE RESHEATHING TOOL. THERE IS EXTERNAL MECHANICAL SHEATH DAMAGE AT THE DISTAL TIP OF THE SKIVE RESULTING IN THE SKIVE OPENING. THE COIL¿S SOCKET RING HAS BEEN PUSHED DOWN INSIDE THE OUTER SHEATH. TO DETERMINE IF THE DETACHMENT FIBER RECEIVED HEAT AND MELTED, IN THE LABORATORY THE COIL¿S SOCKET RING WAS PULLED OUT FROM UNDER THE OUTER SHEATH TO INSPECT THE FIBER. IT IS CONFIRMED THAT THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH AND THE EXTENDED EDGES OFF THE V HAVE BEEN DAMAGED. THE LOCKING MECHANISM AND THE SHEATH HAVE BEEN DAMAGED. UPON RECEIPT, THE DPU PASSED ELECTRICAL TESTING WITH RESISTANCE AT 50.3 OHMS AND THE ENPOWER SYSTEM ¿GO¿ (GREEN) LIGHT ILLUMINATED. THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE DURING THE LABORATORY TEST. THE POST-DETACHMENT RESISTANCE IS 50.3 OHMS. POST-DETACHMENT INSPECTION SHOWS THAT THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. THEREFORE, THE ROOT CAUSE OF THE FAILURE OF THE COIL TO DETACH INSIDE THE ANEURYSM CANNOT BE DETERMINED AS THE DPU PASSED ELECTRICAL INSPECTION AND THE COIL DETACHED ON THE FIRST ATTEMPT. 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 CONTRIBUTED TO THE COMPLAINT EVENT. THE CORE WIRE PROTRUSION OUTSIDE THE SHEATH AND THE COIL¿S SOCKET RING BEING LODGED DOWN INSIDE THE OUTER SHEATH INDICATE THAT THERE WAS SOME DIFFICULTY ENCOUNTERED IN RESHEATHING THE COIL FOLLOWING THE FAILED DETACHMENT. THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE RESHEATHING DIFFICULTY. BOTH OF THESE CONTRIBUTING FACTORS MAY HAVE WORKED SEPARATELY OR IN TANDEM PRODUCING SIMILAR RESULTS. THE PRIMARY CONTRIBUTING FACTOR MOST LIKELY 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. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE AND MAY HAVE CAUSED THE CORE WIRE TO PROTRUDE OUTSIDE THE SHEATH AND FOR THE COIL¿S SOCKET RING TO BECOME LODGED INSIDE THE OUTER SHEATH. IN THIS CONDITION, ADVANCING OR RESHEATHING THE COIL CANNOT BE PERFORMED. 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).¿ THE POSSIBLE SECONDARY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO DISTAL INTERFERENCE INSIDE THE UNIDENTIFIED MICROCATHETER, WHICH WAS NOT RETURNED FOR ANALYSIS. THIS DISTAL INTERFERENCE MAY HAVE CAUSED THE CORE WIRE TO SEVERELY KINK AND PROTRUDE OUTSIDE THE SHEATH. IN THIS CONDITION, RESHEATHING THE COIL CANNOT BE PERFORMED. THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE FULLY DETERMINED. WITHOUT THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. IT WAS ALSO OBSERVED THAT EXTERNAL MECHANICAL SHEATH DAMAGE OCCURRED TO THE DISTAL TIP OF THE SKIVE RESULTING IN AN OPENED SKIVE. THIS MAY HAVE OCCURRED WHEN THE RESHEATHING TOOL WAS ADVANCED OVER THE PROXIMAL END OF THE GREEN INTRODUCER. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS,¿¿ CONTINUE SLIDING THE INTRODUCER TIP UNTIL JUST BEFORE THE TIP REACHES THE DISTAL END OF THE RE SHEATHING TOOL, LEAVING APPROXIMATELY 1 INCH OF THE UNSHEATHED INTRODUCER SHEATH STILL VISIBLE.¿¿ 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 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.
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 WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING COIL EMBOLIZATION OF AN OPHTHALMIC ANEURYSM OF SIZE 3.56 X 4.35 MM IN A (B)(6) YR OLD MALE PATIENT, THE FINAL COIL, A DELTAPAQ CERECYTE MICROCOIL 1.5 MM X 6 CM (CDF10015630/(B)(4)), COULD NOT BE DETACHED FROM THE DELIVERY SYSTEM AFTER THE GUIDE WIRE WAS WITHDRAWN. THE PHYSICIAN ATTEMPTED TO DETACH A SECOND TIME BUT IT STILL FAILED. HE THEN WITHDREW THE COIL AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT TO THE PATIENT IS REPORTED TO HAVE OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE COIL AND THE DEVICE POSITIONING UNIT (DPU) WERE RETURNED FOR LABORATORY ANALYSIS. THE COIL WAS RETURNED UNDAMAGED. LOCATED 12.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH UNTIL ENTERING THE RESHEATHING TOOL. THERE IS EXTERNAL MECHANICAL SHEATH DAMAGE AT THE DISTAL TIP OF THE SKIVE RESULTING IN THE SKIVE OPENING. THE COIL¿S SOCKET RING HAS BEEN PUSHED DOWN INSIDE THE OUTER SHEATH. TO DETERMINE IF THE DETACHMENT FIBER RECEIVED HEAT AND MELTED, IN THE LABORATORY THE COIL¿S SOCKET RING WAS PULLED OUT FROM UNDER THE OUTER SHEATH TO INSPECT THE FIBER. IT IS CONFIRMED THAT THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH AND THE EXTENDED EDGES OFF THE V HAVE BEEN DAMAGED. THE LOCKING MECHANISM AND THE SHEATH HAVE BEEN DAMAGED. UPON RECEIPT, THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 50.3 OHMS AND THE ENPOWER SYSTEM ¿GO¿ (GREEN) LIGHT ILLUMINATED. THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE DURING THE LABORATORY TEST. THE POST-DETACHMENT RESISTANCE IS 50.3 OHMS. POST-DETACHMENT INSPECTION SHOWS THAT THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. THEREFORE, THE ROOT CAUSE OF THE FAILURE OF THE COIL TO DETACH INSIDE THE ANEURYSM CANNOT BE DETERMINED AS THE DPU PASSED ELECTRICAL INSPECTION AND THE COIL DETACHED ON THE FIRST ATTEMPT. 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 CONTRIBUTED TO THE COMPLAINT EVENT. THE CORE WIRE PROTRUSION OUTSIDE THE SHEATH AND THE COIL¿S SOCKET RING BEING LODGED DOWN INSIDE THE OUTER SHEATH INDICATE THAT THERE WAS SOME DIFFICULTY ENCOUNTERED IN RESHEATHING THE COIL FOLLOWING THE FAILED DETACHMENT. THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE RESHEATHING DIFFICULTY. BOTH OF THESE CONTRIBUTING FACTORS MAY HAVE WORKED SEPARATELY OR IN TANDEM PRODUCING SIMILAR RESULTS. THE PRIMARY CONTRIBUTING FACTOR MOST LIKELY 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. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE AND MAY HAVE CAUSED THE CORE WIRE TO PROTRUDE OUTSIDE THE SHEATH AND FOR THE COIL¿S SOCKET RING TO BECOME LODGED INSIDE THE OUTER SHEATH. IN THIS CONDITION, ADVANCING OR RESHEATHING THE COIL CANNOT BE PERFORMED. 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).¿ THE POSSIBLE SECONDARY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO DISTAL INTERFERENCE INSIDE THE UNIDENTIFIED MICROCATHETER, WHICH WAS NOT RETURNED FOR ANALYSIS. THIS DISTAL INTERFERENCE MAY HAVE CAUSED THE CORE WIRE TO SEVERELY KINK AND PROTRUDE OUTSIDE THE SHEATH. IN THIS CONDITION, RESHEATHING THE COIL CANNOT BE PERFORMED. THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE FULLY DETERMINED. WITHOUT THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. IT WAS ALSO OBSERVED THAT EXTERNAL MECHANICAL SHEATH DAMAGE OCCURRED TO THE DISTAL TIP OF THE SKIVE RESULTING IN AN OPENED SKIVE. THIS MAY HAVE OCCURRED WHEN THE RESHEATHING TOOL WAS ADVANCED OVER THE PROXIMAL END OF THE GREEN INTRODUCER. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS,¿¿ CONTINUE SLIDING THE INTRODUCER TIP UNTIL JUST BEFORE THE TIP REACHES THE DISTAL END OF THE RE SHEATHING TOOL, LEAVING APPROXIMATELY 1 INCH OF THE UNSHEATHED INTRODUCER SHEATH STILL VISIBLE.¿¿ 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 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.
WHEN THE SURGEON FILLED THE LAST DELTAPAQ CERECYTE MICROCOIL 1.5 MM X 6 CM (CDF10015630/M10204) IT COULD NOT BE DETACHED WITH DELIVERY SYSTEM AFTER THE GUIDE WIRE WAS WITHDRAWN. HE PRESSED THE KEY AGAIN BUT STILL FAILED. THE SURGEON WITHDREW THE COIL AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT OCCURRED. THE PROCEDURE WAS FOR AN OPHTHALMIC ARTERY ANEURYSM. SIZE IS 3.56*4.35MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353921 | DELTAPAQ - CERECYTE MICROCOIL | CNV DCS COILS | HCG | MICRUS ENDOVASCULAR, LLC | NA | M10204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | NEW COIL (DETAILS UNKNOWN) |