TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
Report
- Report Number
- 1058196-2011-00056
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
A NON-STERILE TRUFILL DCS WAS RECEIVED ACCOMPANIED OF ONE NON-CORDIS MICROCATHETER AND ONE Y-CONNECTOR INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE EMBOLIC COIL WAS RECEIVED SEPARATED FROM THE DEVICE AND IT WAS FOUND WITHOUT DAMAGE. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. RECEIVED TRUFILL DCS ORBIT WAS INSERTED INTO A MICROCATHETER PROWLER SELECT PLUS CORDIS LAB SAMPLE, WHICH WAS PREVIOUSLY FLUSHED, EVEN THE DAMAGES PRESENTED ON THE DEVICE IT COULD LEAVE FROM THE MICROCATHETER'S TIP. 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 CUSTOMER AS ''DCS'' RESISTANCE/FRICTION WAS NOT CONFIRMED DURING THE FUNCTIONAL TEST. THE FAILURE ''COIL'' UNRAVELED/STRETCHED WAS NOT CONFIRMED DURING THE MICROSCOPIC ANALYSIS. THE CAUSE OF THE COIL SEPARATED AND THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVE DETERMINATE HOWEVER THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS. 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 OF RECEIPT.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE FIRST ORBIT RDFL COMPLEX STANDARD COIL WAS INSERTED INTO A RECURRENT LEFT A1/A2 JUNCTION ANEURYSM, WHICH HAD BEEN COILED BEFORE, BUT WHEN REPOSITIONING THE MICROCATHETER, THE COIL WAS RETRACTED AND IT STRETCHED. ADDITIONAL INFORMATION REPORTED THAT NO RESISTANCE WAS NOTED WHEN TRYING TO PULL THE COIL BACK; THERE WAS AN IMMEDIATE LOSS OF ONE TO ONE FEEL WHEN THEY TRIED TO WITHDRAW THE COIL. IT SEEMED TO HAVE STRETCHED ON INSERTION INTO THE ANEURYSM. THE EXCELSIOR 10 MICROCATHETER (MC) WAS WITHDRAWN SINCE COIL/DELIVERY SYSTEM WERE STUCK TOGETHER. THE ANEURYSM WAS SACCULAR WITH A MEASUREMENT OF 14MMX9MM AND THE NECK WAS 4MM. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT, THERE WAS AN IMMEDIATE LOSS OF ONE TO ONE FEEL, HOWEVER ONE TO ONE RELATIONSHIP BETWEEN THE COIL & DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, THE COIL COULD NOT BE REPOSITIONED AS THERE WAS NO LONGER ONE TO ONE BETWEEN COIL AND DELIVERY SYSTEM. NO DAMAGES WERE NOTED ON THE MC. BESIDES THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH DELIVERY SYSTEM (BROKEN, FRACTURE, ETC) OR COIL (KINK, BEND, STRETCHED, UNRAVELED, BROKEN, FRACTURE, ETC). AFTER THE EVENT, THE ANEURYSM WAS OBLITERATED AND THE PATIENT WAS IN GOOD CONDITION. A NON-STERILE TRUFILL DCS WAS RECEIVED ACCOMPANIED BY ONE NON-CORDIS MICROCATHETER AND ONE Y-CONNECTOR INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE EMBOLIC COIL WAS RECEIVED SEPARATED FROM THE DEVICE AND IT WAS FOUND WITHOUT DAMAGE. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. THE IMPRESSION OF THE HEADPIECE WAS SEEN IN THE GRIPPER WHICH INDICATES A TIGHT FIT OF THE PREVIOUSLY INSERTED COIL HEADPIECE. RECEIVED TRUFILL DCS ORBIT DELIVERY SYSTEM WAS INSERTED INTO A LAB SAMPLE PROWLER SELECT PLUS CORDIS MICROCATHETER, WHICH WAS PREVIOUSLY FLUSHED. EVEN THE DAMAGES PRESENTED ON THE DEVICE IT COULD BE ADVANCED OUT THE DISTAL END OF THE MICROCATHETER. 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 REPORTED UNRAVELED/STRETCHED COIL WAS NOT CONFIRMED WITH ANALYSIS; HOWEVER, THE COIL WAS DETACHED FROM THE DELIVERY SYSTEM. THERE WAS NO RESISTANCE FRICTION WITH FUNCTIONAL TESTING OF THE DELIVERY SYSTEM. BASED ON THE REPORTED INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE ANALYSIS FINDINGS; HOWEVER IT IS POSSIBLE THAT THE REPORTED LOSS OF ONE-TO-ONE WAS RELATED TO COIL DETACHMENT IN THE PRESENCE OF MANIPULATION DURING POSITIONING. BASED ON THE ANALYSIS AND DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENTS OR RETURNED CONDITION OF THE UNIT. IT IS POSSIBLE THAT DEVICE MANIPULATION DUE TO ANEURYSM/VESSEL CHARACTERISTICS CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
ADDITIONAL INFORMATION INDICATED THAT THE ORIGINAL REPORT WAS INCORRECT AND PART OF THE EVENT SHOULD HAVE STATED THAT THERE WAS AN IMMEDIATE LOSS OF ONE TO ONE FEEL WHEN THEY TRIED TO WITHDRAW THE COIL. THEY FELT NO RESISTANCE WHEN THEY TRIED TO RETRACT THE COIL. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE FIRST ORBIT RDFL COMPLEX STANDARD COIL WAS INSERTED INTO A RECURRENT LEFT A1/A2 JUNCTION ANEURYSM, WHICH HAD BEEN COILED BEFORE, BUT WHEN REPOSITIONING THE MICROCATHETER, THE COIL WAS RETRACTED AND IT STRETCHED. RESISTANCE WAS NOTED WHEN TRYING TO PULL THE COIL BACK; IT SEEMED TO HAVE STRETCHED ON INSERTION INTO THE ANEURYSM. THE EXCELSIOR 10 MICROCATHETER (MC) WAS WITHDRAWN SINCE COIL/DELIVERY SYSTEM WERE STUCK TOGETHER. THE ANEURYSM WAS SACCULAR WITH A MEASUREMENT OF 14 MM X 9 MM AND THE NECK WAS 4 MM. A BALLOON REMODELING DEVICE WAS NOT UTILIZED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT, THERE WAS AN IMMEDIATE LOSS OF ONE TO ONE FEEL, HOWEVER ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, THE COIL COULD NOT BE REPOSITIONED AS THERE WAS NO LONGER ONE TO ONE BETWEEN COIL AND DELIVERY SYSTEM. NO DAMAGES WERE NOTED ON THE MC. BESIDES THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH DELIVERY SYSTEM (BROKEN, FRACTURE, ETC) OR COIL (KINK, BEND, STRETCHED, UNRAVELED, BROKEN, FRACTURE, ETC). AFTER THE EVENT, THE ANEURYSM WAS OBLITERATED AND THE PATIENT WAS IN GOOD CONDITION. A NON-STERILE TRUFILL DCS WAS RECEIVED ACCOMPANIED BY ONE NON-CORDIS MICROCATHETER AND ONE Y-CONNECTOR INSIDE A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE EMBOLIC COIL WAS RECEIVED SEPARATED FROM THE DEVICE AND IT WAS FOUND WITHOUT DAMAGE. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. THE IMPRESSION OF THE HEADPIECE WAS SEEN IN THE GRIPPER WHICH INDICATES A TIGHT FIT OF THE PREVIOUSLY INSERTED COIL HEADPIECE. RECEIVED TRUFILL DCS ORBIT DELIVERY SYSTEM WAS INSERTED INTO A LAB SAMPLE PROWLER SELECT PLUS CORDIS MICROCATHETER, WHICH WAS PREVIOUSLY FLUSHED. EVEN THE DAMAGES PRESENTED ON THE DEVICE IT COULD BE ADVANCED OUT THE DISTAL END OF THE MICROCATHETER. 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 REPORTED UNRAVELED/STRETCHED COIL WAS NOT CONFIRMED WITH ANALYSIS; HOWEVER, THE COIL WAS DETACHED FROM THE DELIVERY SYSTEM. THERE WAS NO RESISTANCE FRICTION WITH FUNCTIONAL TESTING OF THE DELIVERY SYSTEM. BASED ON THE REPORTED INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE ANALYSIS FINDINGS; HOWEVER IT IS POSSIBLE THAT THE REPORTED LOSS OF ONE-TO-ONE WAS RELATED TO COIL DETACHMENT IN THE PRESENCE OF RESISTANCE DURING POSITIONING. THE INSTRUCTIONS FOR USE CAUTIONS TO NEVER ADVANCE, WITHDRAW, OR TORQUE THE DELIVERY TUBE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF THE RESISTANCE UNDER FLUOROSCOPY. THESE MANIPULATIONS OF THE DELIVERY TUBE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. BASED ON THE ANALYSIS AND DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENTS OR RETURNED CONDITION OF THE UNIT. IT IS POSSIBLE THAT DEVICE MANIPULATION DUE TO ANEURYSM/VESSEL CHARACTERISTICS CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
DURING A COIL EMBOLIZATION PROCEDURE, THE FIRST ORBIT RDFL COMPLEX STANDARD COIL WAS INSERTED INTO A RECURRENT ANEURYSM, WHICH HAD BEEN COILED BEFORE, BUT WHEN REPOSITIONING THE MICROCATHETER, THE COIL WAS RETRACTED AND IT STRETCHED. RESISTANCE WAS NOTED WHEN TRYING TO PULL THE COIL BACK IT SEEMED TO HAVE STRETCHED ON INSERTION INTO THE ANEURYSM. THE EXCELSIOR 10 MICROCATHETER WAS WITHDRAWN, SINCE COIL/DELIVERY SYSTEM WAS STUCK TOGETHER. 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 DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND NO KINKS WERE NOTED ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM. DURING PLACEMENT, THERE WAS AN IMMEDIATE LOSS OF ONE TO ONE FEEL, HOWEVER ONE TO ONE RELATIONSHIP BETWEEN THE COIL & DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING THE REPOSITIONING PROCESS, THE COIL DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE (LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER). AFTER REPOSITIONING, THE COIL COULD NOT BE REPOSITIONED AS THERE WAS NO LONGER ONE TO ONE BETWEEN COIL AND DELIVERY SYSTEM. NO DAMAGES WERE NOTED ON THE MICROCATHETER. BESIDES THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH DELIVERY SYSTEM (BROKEN, FRACTURE, ETC) OR COIL (KINK, BEND, STRETCHED, UNRAVELED, BROKEN, FRACTURE, ETC), AND THE COIL IS GOING TO BE RETURNED FOR ANALYSIS. AFTER THE EVENT, THE ANEURYSM WAS OBLITERATED AND THE PATIENT WAS IN GOOD CONDITION. THE TARGET SITE WAS THE LEFT A1/A2 JUNCTION, AND THE ANEURYSM WAS SACCULAR WITH A MEASUREMENT 0F 14MMX9MM, AND THE NECK WAS 3/1MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX | CNV DCS ORBIT (HCG) | HCG | CORDIS NEUROVASCULAR, INC. | NA | 13471454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | EXCELSIOR SL-10 |