TRUFILL DCS ORBIT MINI COMPLEX FILL
Report
- Report Number
- 1058196-2011-00058
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
DURING A STENT ASSISTED COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM THE TENTH COIL, A 3X6 TRUFILL DCS ORBIT MINI COMPLEX FILL, COULD NOT BE DETACHED. WHEN MORE PRESSURE WAS APPLIED IN ATTEMPT TO DETACH THE COIL, THE HUB CRACKED AND SALINE BEGAN TO LEAK. AFTER THE COIL COULD NOT BE DETACHED, THE EXCELSIOR SL10/BOSTON SCIENTIFIC MICROCATHETER WAS PULLED BACK TO THE PROXIMAL VESSEL AND THEN THE COIL DELIVERY SYSTEM WAS PULLED BACK. THERE WAS RESISTANCE WITH WITHDRAWAL OF THE COIL DELIVERY SYSTEM. WHEN THE DELIVERY SYSTEM WAS PULLED BACK, THE EMBOLIC COIL UNRAVELED AND DETACHED FROM THE DELIVERY SYSTEM. THE UNRAVELED COIL WAS PLACED AND FIXED BETWEEN THE VESSEL WALL AND THE ENTERPRISE STENT. THE COIL DELIVERY SYSTEM AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND OTHER COILS WERE USED TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE EVENT. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING WITHIN THE ANEURYSM. IT IS NOT KNOWN IF THE SYRINGE HAD BEEN USED WITH MORE THAN THE MAXIMUM OF 5 COILS AS OUTLINED IN THE INSTRUCTIONS FOR USE; HOWEVER, THE DCS SYRINGE II WAS ABLE TO BE USED SUCCESSFULLY WITH OTHER PRODUCTS, SINCE IT WAS NOT DAMAGED. PRIOR TO THE FAILURE TO DETACH, THE SYRINGE WAS NOT TAKING PAST THE GREEN ZONE, POSITION 3 OR RED ZONE. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE. PRIOR TO INSERTING THE 10TH COIL, THE COIL HAD NOT BEEN INITIALLY UTILIZED AND THEN REMOVED FROM THE PATIENT. NO KINKS WERE NOTED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. AFTER REMOVAL FROM THE PATIENT, SOME DAMAGE WAS NOTED ON THE DELIVERY SYSTEM DETAILS ARE UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE. FOURTEEN NON STERILE TRUFILL DCS WERE RECEIVED IN TANGLED CONDITION INSIDE A PLASTIC BAG. IN THE SAME BAG WERE RECEIVED ONE NON CORDIS MICROCATHETER WITH A "Y" CONNECTOR AND ONE CODMAN SYRINGE II (B)(4). ALL OF THE DEVICES WERE FLUSHING ONE BY ONE IN ORDER TO IDENTIFY THE UNIT WITH THE FAILURE REPORTED "HUB CRACK". AT THE END OF THE FUNCTIONAL TEST ONE UNIT WAS IDENTIFIED WITH A HUB CRACK AND THE RESULTS OF THE VISUAL ANALYSIS WERE THE FOLLOWING: THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS FOUND UNZIPPED WITH SEVERAL BENDS. THE SUPPORT COIL AND GRIPPER WERE FOUND OUTSIDE OF THE INTRODUCER AND NO DAMAGES WERE FOUND ON THEM. EMBOLIC COIL WAS NOT RECEIVED FOR THE EVALUATION. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE DEVICE WAS FLUSHED WITH THE SYRINGE INVOLVED IN THE COMPLAINT AND A LEAKAGE WAS FOUND IN THE HUB. THE GRIPPER AND THE HUB WERE INSPECTED UNDER MICROSCOPE AND THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE HUB WAS FOUND CRACKED. THE UNIT WAS SENT TO THE SEM ANALYSIS. THE SEM RESULTS SHOWED MULTIPLE CRACKS COULD BE NOTED IN THE EXTERNAL SURFACE OF THIS PIECE ALONG WITH THE CRAZES THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE HUB. THE SAMPLE EXHIBITS AREAS THAT LOOK BRITTLE IN APPEARANCE. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. THE EXACT CAUSE OF THE HUB CRACK COULD NOT BE CONCLUSIVELY DETERMINED. 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. REVIEW OF LOT 15183325 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED RESISTANCE/FRICTION COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. THE REPORTED STRETCHING OF THE COIL COULD NOT BE EVALUATED SINCE THE COIL WAS NOT RETURNED; IT WAS REPORTED AS REMAINING IN THE PATIENT. THE CAUSE OF THE KINKS AND BENDS NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES ARE MANUFACTURING RELATED. INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THE RECORDS INDICATED THAT THE PRODUCT MEETS SPECIFICATION PRIOR TO SHIPMENT. IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS MAY HAVE IMPACTED THE DAMAGES FOUND ON THE RETURNED DEVICE. THE REPORTED CRACKED HUB WAS CONFIRMED DURING THE FUNCTIONAL ANALYSIS. WITH REVIEW OF THE REPORTED INFORMATION, IT DOES NOT APPEAR THAT THE HUB WAS CRACKED UNTIL ADDITIONAL PRESSURE WAS APPLIED AFTER INITIAL ATTEMPT TO DETACH THE COIL. IF THE HUB HAD BEEN CRACKED PRIOR TO THE APPLICATION OF ADDITIONAL PRESSURE IT IS UNLIKELY THAT THE SYRINGE PRESSURE WOULD HAVE BEEN ABLE TO BE MAINTAINED OR INCREASED EITHER DURING PURGING OR WITH INITIAL ATTEMPT TO PRESSURIZE. IT IS NOT KNOWN HOW MUCH EXTRA PRESSURE WAS APPLIED. HOWEVER, LOSS OF PRESSURE DUE THE HUB CRACK AT HIGHER PRESSURE WOULD IMPACT THE ABILITY TO DETACH THE COIL. BASED ON THE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE THE ROOT CAUSE OF THE HUB CRACK CANNOT BE CONCLUSIVELY DETERMINED. A RISK ASSESSMENT HAS BEEN INITIATED TO EVALUATE THIS ISSUE. ACTION WAS OPENED TO ADDRESS THE ORBIT HUB CRACK.
DURING A STENT ASSISTED COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM THE TENTH COIL, A 3X6 TRUFILL DCS ORBIT MINI COMPLEX FILL, COULD NOT BE DETACHED. WHEN MORE PRESSURE WAS APPLIED IN ATTEMPT TO DETACH THE COIL, THE HUB CRACKED AND SALINE BEGAN TO LEAK. AFTER THE COIL COULD NOT BE DETACHED, THE EXCELSIOR SL10/BOSTON SCIENTIFIC MICROCATHETER WAS PULLED BACK TO THE PROXIMAL VESSEL AND THEN THE COIL DELIVERY SYSTEM WAS PULLED BACK. THERE WAS RESISTANCE WITH WITHDRAWAL OF THE COIL DELIVERY SYSTEM. WHEN THE DELIVERY SYSTEM WAS PULLED BACK, THE EMBOLIC COIL UNRAVELED AND DETACHED FROM THE DELIVERY SYSTEM. THE UNRAVELED COIL WAS PLACED AND FIXED BETWEEN THE VESSEL WALL AND THE ENTERPRISE STENT. THE COIL DELIVERY SYSTEM AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND OTHER COILS WERE USED TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE EVENT. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING WITHIN THE ANEURYSM. IT IS NOT KNOWN IF THE SYRINGE HAD BEEN USED WITH MORE THAN THE MAXIMUM OF 5 COILS AS OUTLINED IN THE INSTRUCTIONS FOR USE; HOWEVER, THE DCS SYRINGE II WAS ABLE TO BE USED SUCCESSFULLY WITH OTHER PRODUCTS, SINCE IT WAS NOT DAMAGED. PRIOR TO THE FAILURE TO DETACH, THE SYRINGE WAS NOT TAKING PAST THE GREEN ZONE, POSITION 3 OR RED ZONE. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE. PRIOR TO INSERTING THE 10TH COIL, THE COIL HAD NOT BEEN INITIALLY UTILIZED AND THEN REMOVED FROM THE PATIENT. NO KINKS WERE NOTED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. AFTER REMOVAL FROM THE PATIENT, SOME DAMAGE WAS NOTED ON THE DELIVERY SYSTEM DETAILS ARE UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE. FOURTEEN NON STERILE TRUFILL DCS WERE RECEIVED IN TANGLED CONDITION INSIDE A PLASTIC BAG. IN THE SAME BAG WERE RECEIVED ONE NON CORDIS MICROCATHETER WITH A "Y" CONNECTOR AND ONE CODMAN SYRINGE II (635-002). ALL OF THE DEVICES WERE FLUSHING ONE BY ONE IN ORDER TO IDENTIFY THE UNIT WITH THE FAILURE REPORTED "HUB CRACK." AT THE END OF THE FUNCTIONAL TEST ONE UNIT WAS IDENTIFIED WITH A HUB CRACK AND THE RESULTS OF THE VISUAL ANALYSIS WERE THE FOLLOWING: THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS FOUND UNZIPPED WITH SEVERAL BENDS. THE SUPPORT COIL AND GRIPPER WERE FOUND OUTSIDE OF THE INTRODUCER AND NO DAMAGES WERE FOUND ON THEM. EMBOLIC COIL WAS NOT RECEIVED FOR THE EVALUATION. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE DEVICE WAS FLUSHING WITH THE SYRINGE INVOLVED IN THE COMPLAINT AND A LEAKAGE WAS FOUND IN THE HUB. THE GRIPPER AND THE HUB WERE INSPECTED UNDER MICROSCOPE AND THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE HUB WAS FOUND CRACKED. THE UNIT WAS SEND TO THE SEM ANALYSIS. THE SEM RESULTS SHOWED MULTIPLE CRACKS COULD BE NOTED IN THE EXTERNAL SURFACE OF THIS PIECE ALONG WITH THE CRAZES THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE HUB. THE SAMPLE EXHIBITS AREAS THAT LOOK BRITTLE IN APPEARANCE. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. THE EXACT CAUSE OF THE HUB CRACK COULD NOT BE CONCLUSIVELY DETERMINED. 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. REVIEW OF LOT 15183325 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED CRACKED HUB WAS CONFIRMED DURING THE FUNCTIONAL ANALYSIS. THE EXACT CAUSE OF THE HUB CRACK COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, BASED ON THE ANALYSIS, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. WITH REVIEW OF THE REPORTED INFORMATION, IT DOES NOT APPEAR THAT THE HUB WAS CRACKED UNTIL ADDITIONAL PRESSURE WAS APPLIED AFTER INITIAL ATTEMPT TO DETACH THE COIL. IF THE HUB HAD BEEN CRACKED PRIOR TO THE APPLICATION OF ADDITIONAL PRESSURE IT IS UNLIKELY THAT THE SYRINGE PRESSURE WOULD HAVE BEEN ABLE TO BE MAINTAINED OR INCREASED EITHER DURING PURGING OR WITH INITIAL ATTEMPT TO PRESSURIZE. IT IS NOT KNOWN HOW MUCH EXTRA PRESSURE WAS APPLIED. BASED ON THE ANALYSIS AND THE RETURNED CONDITION OF THE DEVICE AND THE REPORTED INFORMATION, THE ROOT CAUSE OF THE FAILURE OF THE COIL DETACH CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED RESISTANCE/FRICTION COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. THE REPORTED STRETCHING OF THE COIL COULD NOT BE EVALUATED SINCE THE COIL WAS NOT RETURNED; IT WAS REPORTED AS REMAINING IN THE PATIENT. THE CAUSE OF THE KINKS AND BENDS NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES ARE MANUFACTURING RELATED. INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THE RECORDS INDICATED THAT THE PRODUCT MEETS SPECIFICATION PRIOR TO SHIPMENT. IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS MAY HAVE IMPACTED THE STRETCHING AND SUBSEQUENT COIL DETACHMENT DURING WITHDRAWAL. HOWEVER THE EXACT CAUSE OF THE EVENTS AND DAMAGES REMAINS INCONCLUSIVELY AND UNDETERMINED; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
THE DCS SYRINGE II (635-002, LOT# UNK) WAS ABLE TO BE USE WITH OTHER PRODUCTS, SINCE IT WAS NOT DAMAGED. PRIOR TO THE FAILURE TO DETACHED, THE SYRINGE WAS NOT TAKING PAST THE GREEN ZONE, POSITION 3 OR RED ZONE. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE. PRIOR TO INSERTING THE 10TH COIL, THE COIL WAS NOT INITIALLY UTILIZED AND THEN REMOVED FROM THE PATIENT. NO KINKS WERE NOTED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. AFTER REMOVAL FROM THE PATIENT, SOME DAMAGE WAS NOTED ON THE DELIVERY SYSTEM DETAILS IS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
FOURTEEN NON STERILE TRUFILL DCS WERE RECEIVED IN TANGLED CONDITION INSIDE A PLASTIC BAG. IN THE SAME BAG WERE RECEIVED ONE NON CORDIS MICROCATHETER WITH A "Y" CONNECTOR AND ONE CODMAN SYRINGE II (635-002). ALL OF THE DEVICES WERE FLUSHING ONE BY ONE IN ORDER TO IDENTIFY THE UNIT WITH THE FAILURE REPORTED "HUB CRACK." AT THE END OF THE FUNCTIONAL TEST ONE UNIT WAS IDENTIFIED WITH A HUB CRACK AND THE RESULTS OF THE VISUAL ANALYSIS WERE THE FOLLOWING: THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS FOUND UNZIPPED WITH SEVERAL BENDS. THE SUPPORT COIL AND GRIPPER WERE FOUND OUTSIDE OF THE INTRODUCER AND NO DAMAGES WERE FOUND ON THEM. EMBOLIC COIL WAS NOT RECEIVED FOR THE EVALUATION. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE DEVICE WAS FLUSHING WITH THE SYRINGE INVOLVED IN THE COMPLAINT AND A LEAKAGE WAS FOUND IN THE HUB. THE GRIPPER AND THE HUB WERE INSPECTED UNDER MICROSCOPE AND THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE HUB WAS FOUND CRACKED. THE UNIT WAS SEND TO THE SEM ANALYSIS. THE SEM RESULTS SHOWED MULTIPLE CRACKS COULD BE NOTED IN THE EXTERNAL SURFACE OF THIS PIECE ALONG WITH THE CRAZES THAT WENT THROUGH THE WHOLE WALL THICKNESS OF THE HUB. THE SAMPLE EXHIBITS AREAS THAT LOOK BRITTLE IN APPEARANCE. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. THE EXACT CAUSE OF THE HUB CRACK COULD NOT BE CONCLUSIVELY DETERMINED. REPORTED FAILURE AS DCS RESISTANCE/FRICTION COULD NOT BE EVALUATED DUE TO THE CONDITIONS OF THE RECEIVED UNIT. THE REPORTED FAILURES AS "COIL UNRAVELED/STRETCHED, COIL FAILURE TO DETACH AND COIL PROTRUSION" COULD NOT BE EVALUATED SINCE THE EMBOLIC COIL WAS NOT RECEIVED FOR THE ANALYSIS AND THE REPORTED FAILURE AS "HUB CRACK" WAS CONFIRMED DURING THE FUNCTIONAL ANALYSIS. THE EXACT CAUSE OF THE HUB CRACK COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED DUE TO PER CH&SS INVESTIGATION THE CUSTOMER STATE THAT "WHEN MORE PRESSURE WAS APPLIED TO DETACH, THE HUB WAS CRACKED" AND THERE WAS NO FAILURE REPORTED DURING THE PURGED OF THE DEVICE; WHICH COULD INDICATE THAT THE HUB CRACK OCCUR AT THE TIME WHEN THE PRESSURE WAS INCREASE OTHERWISE THE DEVICE COULD NOT BE PURGE AND THE HUB LEAK COULD BE OBSERVED AT THE BEGINNING OF THE PROCEDURE. THE CAUSE OF THE KINKS AND BENDS NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THESE DAMAGES COULD BE MANUFACTURING RELATED. INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THE RECORDS INDICATED THAT THE PRODUCT MEETS SPECIFICATION PRIOR TO SHIPMENT; PROCEDURAL AND HANDLING FACTORS APPEARS TO IMPACT IN THE FAILURES REPORTED; HOWEVER THE EXACT CAUSE OF THIS DAMAGES REMAINS INCONCLUSIVELY AND UNDETERMINED; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION ASSISTED WITH THE VRD ENTERPRISE (CATALOG/LOT UNKNOWN) FOR AN ANEURYSM IN (BA) BASILAR ARTERY- TOP, THE 10TH COIL (ORBIT MINI COMPLEX FILL 3X6-637MF0306/15183325) COULD NOT BE DETACHED, BUT WHEN MORE PRESSURE WAS APPLIED TO DETACH, THE HUB CRACKED AND SALINE BEGAN TO LEAK. AFTER THE COIL COULD NOT BE DETACHED, THE NON-CORDIS (MC) MICROCATHETER WAS PULLED BACK TO THE PROXIMAL VESSEL AND THEN THE COIL DELIVERY SYSTEM WAS PULLED BACK, AND THE COIL UNRAVELED. ADDITIONALLY, IT WAS REPORTED THERE WAS A DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM AFTER THE COIL UNRAVELED. AFTER THE COIL UNRAVELED, THE COIL PREMATURELY DETACHED FROM THE DELIVERY SYSTEM WHEN PULLING BACK, AND THE ENTIRE COIL REMAINED WITHIN THE ANEURYSM AND THE VESSEL. THE ENTIRE EMBOLIC COIL WAS PLACED AND FIXED BETWEEN THE VESSEL WALL AND THE ENTERPRISE STENT, AND THE DELIVERY SYSTEM AND THE MC WERE REMOVED FROM THE PATIENT. ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. DURING WITHDRAWAL OF THE COIL THERE WAS RESISTANCE. THE COIL DELIVERY SYSTEM WAS WITHDRAWN FROM THE PATIENT AND OTHER COILS WERE USED TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE EVENT.
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 | 15183325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Life Threatening| R | MICROCATHETER AND COILS. |