TRUFILL DCS ORBIT MINI COMPLEX FILL
Report
- Report Number
- 1058196-2010-00356
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 19, 2010
- Report Date
- November 22, 2010
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT HELICAL FILL 3X8 COIL WAS INSERTED INTO THE ANEURYSM BUT FAILED TO ACHIEVE THE HELICAL SHAPE. THE COIL WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THE COIL SHAPE WAS ACHIEVED OUTSIDE OF THE BODY. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE ANEURYSM COIL EMBOLIZATION SUCCESSFULLY. THE ANEURYSM WAS DESCRIBED AS PCOM WITH DIMENSIONS OF 3*4MM, NECK 2MM; NECK TO SAC RATIO WAS ½, AND SIDEWALL. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE (MC) MICROCATHETER, AND NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. THE MC WAS USED THROUGHOUT THE PROCEDURE; HOWEVER, THERE WERE KINKS NOTED AFTER THE PROCEDURE. DURING THE PLACEMENT OF THE COIL, THE DEVICE WAS WITHDRAWN FOR REPOSITIONING AND RESISTANCE WAS FELT, THE WITHDRAWAL PROCESS WAS NOT STOPPED, AND THE CAUSE WAS NOT INVESTIGATED. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL & DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, NEITHER THE COIL NOR THE COIL DELIVERY SYSTEM WAS UTILIZED LIKE A GUIDEWIRE. THE COIL WAS LEFT WITHIN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE ANEURYSM WAS OBLITERATED, AND THE ARTERY WAS LEFT PATENT. THE DEVICE WAS RETURNED FOR ANALYSIS. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND. THE INTRODUCER WAS NOT RECEIVED FOR THE ANALYSIS. THE SUPPORT COIL WAS RECEIVED KINKED AT 21CM FROM THE BODY FUSION. THE EMBOLIC COIL WAS CUT AND RECEIVED IN A SEPARATED SMALL BAG. THE GRIPPER PRESENTED NO DAMAGES AND THE HEADPIECE WAS STILL ATTACHED. THE GRIPPER, EMBOLIC COIL AND HEAD PIECE WERE INSPECTED UNDER MICROSCOPE. THE GRIPPER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND, THE EMBOLIC COIL WAS FOUND STRETCHED AND CUT, JUST THE HEADPIECE WAS ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE COSTUMER AS ¿UNRAVELED/STRETCHED¿ WAS CONFIRMED, THE CAUSE OF THE EMBOLIC COIL STRETCHED AND CUT, KINKS IN THE HYPOTUBE AND THE REST OF THE DAMAGES FOUND ON THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THIS DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. INSPECTIONS ARE IN PLACE AS PER (B)(4) PREVENT THESE KIND OF FAILURES FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF UNRAVELED/STRETCHED WAS CONFIRMED IN ANALYSIS; HOWEVER, THERE IS NO EVIDENCE OF MANUFACTURING RELATED ANOMALIES. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PROCEDURAL AND PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT, SPECIFICALLY THE LOCATION AND DESCRIPTION OF THE ANEURYSM AND THE AMOUNT OF MANIPULATION THE DEVICE UNDERWENT TO DELIVER IT TO THE TARGET LESION.
A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND. THE INTRODUCER WAS NOT RECEIVED FOR THE ANALYSIS. THE SUPPORT COIL WAS RECEIVED KINKED AT 21CM FROM THE BODY FUSION. THE EMBOLIC COIL WAS CUT AND RECEIVED IN A SEPARATED SMALL BAG. THE GRIPPER PRESENTED NO DAMAGES AND THE HEADPIECE WAS STILL ATTACHED. THE GRIPPER, EMBOLIC COIL AND HEAD PIECE WERE INSPECTED UNDER MICROSCOPE. THE GRIPPER WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND, THE EMBOLIC COIL WAS FOUND STRETCHED AND CUT, JUST THE HEADPIECE WAS ATTACHED TO THE GRIPPER. MICROSCOPIC ANALYSIS SHOWED A WEDGE OF SOLDER STILL ATTACHED TO THE COIL HEADPIECE, IN THE AREA BETWEEN THE COIL LOOPS. THIS INDICATES THAT THE SOLDER HAD GOOD ADHESION TO THE COIL HEADPIECE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE COSTUMER AS 'UNRAVELED/STRETCHED' WAS CONFIRMED, THE CAUSE OF THE EMBOLIC COIL STRETCHED AND CUT, KINKS IN THE HYPOTUBE AND THE REST OF THE DAMAGES FOUND ON THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THIS DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.
ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL OR COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE, LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE ANEURYSM WAS OBLITERATED ANT THE ARTERY WAS PATENT. THE ANEURYSM SIZE WAS 3X4MM, NECK 2MM, NECK TO SAC RATIO WAS 1/2, AND IT WAS SIDEWALL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE ORBIT HELICAL FILL 3X8 COIL WAS PUT INTO THE ANEURYSM BUT COULD NOT PERFORM THE HELICAL SHAPE, BUT ONCE IT WAS OUT OF THE PATIENT, THE COIL SHAPE WAS HELICAL, IT IS UNKNOWN IF AFTER REMOVAL IF THE COIL UNRAVELED/STRETCHED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE SURGERY, AND THE PATIENT WAS FINE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE (MC) MICROCATHETER, AND NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. THERE WERE KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT; HOWEVER, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE BECAUSE THERE WERE NO DAMAGES ON THE MC. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT OF THE COIL, THERE WAS RESISTANCE DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM, BUT THE WITHDRAWAL PROCESS WAS NOT STOPPED, AND THE CAUSE WAS NOT INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFILL DCS ORBIT MINI COMPLEX FILL | CNV DCS ORBIT (HCG) | HCG | CORDIS NEUROVASCULAR, INC. | NA | 15000016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | MICROCATHETER |