TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
Report
- Report Number
- 1058196-2010-00343
- Event Type
- Injury
- Date Received
- November 18, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 27, 2010
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
DURING THE EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL WAS ADVANCED, BUT THE PROXIMAL PART OF THE COIL KEPT COMING OUT OF THE ANEURYSM SAC. AN ANGIOGRAM SHOWED THAT THE DISTAL PART OF THE COIL LOOKED STRETCHED. THE DECISION WAS MADE TO USE ANOTHER COIL; THEREFORE THE COIL WAS WITHDRAWN FROM THE PATIENT'S BODY. IT WAS REPORTED THAT THE COIL SEEMED TO BE DETACHED DURING REMOVAL, AND ONCE THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT IT WAS CONFIRMED THAT THE COIL HAD DETACHED. A MICRO SNARE WAS SUCCESSFULLY UTILIZED TO REMOVE THE COIL FROM PATIENT'S BODY WITHOUT CONSEQUENCE TO THE PATIENT. THE ANEURYSM WAS OBLITERATED WITH OTHER COILS. IT WAS FURTHER REPORTED THAT A TWO CATHETER TECHNIQUE WAS USED FOR COILING. THE TWO CATHETERS WERE SUPPOSED TO BE FIXED; HOWEVER, THE PHYSICIAN REPORTED THAT 'HE MIS-CONTROLLED' THE EXCELSIOR 10 MICROCATHETER ONE TIME WHICH CAUSED THE EVENT. THE BASILAR TIP ANEURYSM HAD A SAC DIAMETER OF 7MM, NECK LENGTH OF 4MM AND WAS 8MM TOP TO BOTTOM. THE TWO MICROCATHETER TECHNIQUE WAS UTILIZED BY ADVANCING AN AGILITY 14 (GW) GUIDEWIRE FIRST AND THEN AN AGILITY 10 GW. THEN AN EXCELSIOR 10 MICROCATHETER WAS ADVANCED OVER THE AGILITY 14 AND A PROWLER 14 OVER THE AGILITY 10. AFTER THE TWO MICROCATHETERS APPROACHED THE ENTRANCE OF THE ANEURYSM, THE AGILITY 14 GW AND EXCELSIOR SL10 WERE CONTROLLED AND USED TO CREATE ENOUGH SUPPORT SO THAT THE COIL WOULD NOT COME OUT OF THE ANEURYSM. THE AGILITY 10 GW WITH THE PROWLER 14 WAS THEN ADVANCED TO THE SAC. IT WAS REPORTED THAT THERE WAS NO COMPLAINT OR PROBLEM WITH THE PROWLER 14 MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES, AND THE MC WAS NOT RE-SHAPED PRIOR TO USE. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM, BUT THERE'S WAS SLIGHT POSSIBILITY THAT THE PHYSICIAN GAVE THE COIL SOME TORQUE. DURING PLACEMENT OF THE COIL, THERE WAS NO RESISTANCE DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. DURING THE REPOSITIONING PROCESS, THE COIL WAS NOT UTILIZED LIKE A GUIDEWIRE, LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER. AFTER REPOSITIONING, THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER. THE EMBOLIC COIL AND GRIPPER WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. 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 EVENTS WERE NOT CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICE. WITH FURTHER INVESTIGATION IT WAS REPORTED THAT FURTHER CLARIFICATION AND THE CAUSE OF THE DISCREPANCY CANNOT BE DETERMINED. IT WAS CONFIRMED THAT THERE WAS NO OTHER COMPLAINT DEVICE FROM THIS ACCOUNT. THE CAUSE OF THE KINKS IN THE HYPOTUBE 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 TO PREVENT THIS KIND OF FAILURE FROM LEAVING THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. BASED ON THE REPORTED INFORMATION IT APPEARS THAT THE WIDE NECKED ANEURYSM CHARACTERISTICS CONTRIBUTED TO THE DIFFICULTY POSITIONING THE COIL IN THE ANEURYSM AND THAT DEVICE MANIPULATION/DEVICE INTERACTION CONTRIBUTED TO THE COIL STRETCHING AND PREMATURE DETACHMENT. WITH REVIEW OF THE INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER. THE EMBOLIC COIL AND GRIPPER WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. 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 FAILURES REPORTED BY THE COSTUMER AS 'COIL' POSITIONING DIFFICULTY/UNRAVELED/PREMATURE DETACHMENT WAS NOT CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE KINKS IN THE HYPOTUBE 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 OF RECEIPT.
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 13471475 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS OR EXCURSIONS WERE ISSUED FOR THIS LOT 13471475. COIL ASSY LOTS 14080818 AND 14051389 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW OF THESE LOTS NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE NONCONFORMANCES. THE OPERATOR QUALIFICATION RECORDS FOR LOADING COIL WERE REVIEWED. THE OPERATORS THAT PERFORMED THIS OPERATION WERE QUALIFIED ON THE APPROPRIATE MANUFACTURING WORK INSTRUCTION REVISION AT THE TIME OF THE LOT MANUFACTURING. PREVENTIVE MAINTENANCE RECORDS FOR COIL LOADING MACHINE WAS REVIEWED, AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE ESTABLISHED TIME PERIOD. THE LOT INVOLVED IN THE COMPLAINT WAS MANUFACTURED WITHIN THE PREVENTIVE MAINTENANCE DATES. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
CONCOMITTANT MEDICAL PRODUCTS: AN ENVOY XB MPA 6FRENCH GUIDE CATHETER, AGILITY 14 & AGILITY 10 GUIDEWIRES, PROWLER 14 MP SHAPE AND AN EXCELSIOR SL-10 45` WERE UTILIZED DURING THE PROCEDURE. THERE WAS NO COMPLAINT AGAINST THE PROWLER 14 MICROCATHETER (MC). THE ANEURYSM WAS OBLITERATED WITH OTHER COILS. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES, AND THE MC WAS NOT RE-SHAPED PRIOR TO USE. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM, BUT THERE WAS SLIGHT POSSIBILITY THAT THE PHYSICIAN GAVE THE COIL SOME TORQUE. DURING PLACEMENT OF THE COIL, THERE WAS NO RESISTANCE DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. DURING THE REPOSITIONING PROCESS, THE COIL WAS NOT UTILIZED LIKE A GUIDEWIRE, LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER. AFTER REPOSITIONING, THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE, AND THE COIL IS GOING TO BE RETURNED FOR ANALYSIS. MEDICATION GIVING WAS HEPARIN 4000 UNIT. AFTER THE PROCEDURE, THE PATIENT WAS ALERT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING THE EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL WAS ADVANCED, BUT THE PROXIMAL PART OF THE COIL KEPT COMING OUT OF THE ANEURYSM SAC. AN ANGIOGRAM SHOWED THAT THE DISTAL PART OF THE COIL LOOKED STRETCHED. THE DECISION WAS MADE TO USE ANOTHER COIL; THEREFORE THE COIL WAS WITHDRAWN FROM THE PATIENT'S BODY. HOWEVER, THE COIL SEEMED TO BE DETACHED DURING REMOVAL, AND ONCE THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT IT WAS CONFIRMED THAT THE COIL HAD DETACHED. A MICRO SNARE WAS SUCCESSFULLY UTILIZED TO REMOVE THE COIL FROM PATIENT'S BODY WITHOUT CONSEQUENCE TO THE PATIENT. THE ANEURYSM WAS OBLITERATED WITH OTHER COILS. IT WAS FURTHER REPORTED THAT A TWO CATHETER TECHNIQUE WAS USED FOR COILING. THE TWO CATHETERS WERE SUPPOSED TO BE FIXED; HOWEVER, THE PHYSICIAN REPORTED THAT 'HE MIS-CONTROLLED' THE EXCELSIOR 10 MICROCATHETER ONE TIME WHICH CAUSED THE EVENT. THE BASILAR TIP ANEURYSM HAD A SAC DIAMETER OF 7MM, NECK LENGTH OF 4MM AND WAS 8MM TOP TO BOTTOM. THE TWO MICROCATHETER TECHNIQUE WAS UTILIZED BY ADVANCING AN AGILITY 14 (GW) GUIDEWIRE FIRST AND THEN AN AGILITY 10 GW. THEN AN EXCELSIOR 10 MICROCATHETER WAS ADVANCED OVER THE AGILITY 14 AND A PROWLER 14 OVER THE AGILITY 10. AFTER THE TWO MICROCATHETERS APPROACHED THE ENTRANCE OF THE ANEURYSM, THE AGILITY 14 GW AND EXCELSIOR SL10 WERE CONTROLLED AND USED TO CREATE ENOUGH SUPPORT SO THAT THE COIL WOULD NOT COME OUT OF THE ANEURYSM. THE AGILITY 10 GW WITH THE PROWLER 14 WAS THEN ADVANCED TO THE SAC. IT WAS REPORTED THAT THERE WAS NO COMPLAINT OR PROBLEM WITH THE PROWLER 14 MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES, AND THE MC WAS NOT RE-SHAPED PRIOR TO USE. DURING THE INITIAL INSERTION OF THE COIL DELIVERY SYSTEM, THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC, AND THERE WERE NO KINKS IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING INSERTION, NO ADDITIONAL FORCE WAS UTILIZED TO ADVANCE OR REMOVE THE COIL/DELIVERY SYSTEM, BUT THERE'S WAS SLIGHT POSSIBILITY THAT THE PHYSICIAN GAVE THE COIL SOME TORQUE. DURING PLACEMENT OF THE COIL, THERE WAS NO RESISTANCE DURING WITHDRAWAL FOR REPOSITIONING IN THE ANEURYSM. DURING THE REPOSITIONING PROCESS, THE COIL WAS NOT UTILIZED LIKE A GUIDEWIRE, LEFT IN THE ANEURYSM SAC, WHILE REPOSITIONING THE MICROCATHETER. AFTER REPOSITIONING, THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. 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 FINAL ASSEMBLY LOT 13471475 AND COIL ASSY LOTS 14080818 AND 14051389 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST PER SPECIFICATION. BASED ON THE REPORTED INFORMATION IT APPEARS THAT THE WIDE NECKED ANEURYSM CHARACTERISTICS CONTRIBUTED TO THE DIFFICULTY POSITIONING THE COIL IN THE ANEURYSM AND THAT DEVICE MANIPULATION/DEVICE INTERACTION CONTRIBUTED TO THE COIL STRETCHING AND PREMATURE DETACHMENT. WITH REVIEW OF THE INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
DURING THE EMBOLIZATION PROCEDURE, THE ORBIT RDFL COMPLEX FILL COIL WAS ADVANCED, BUT THE PROXIMAL PART OF THE COIL KEPT GETTING OUT OF THE ANEURYSM SAC. AN ANGIOGRAM SHOWED THAT THE DISTAL PART OF THIS COIL LOOKED STRETCHED. THE DECISION WAS MADE TO USE ANOTHER COIL AND PULLED THE COIL WAS REMOVED FROM THE PATIENT`S BODY, BUT THE COIL SEEMED TO BE DETACHED DURING REMOVAL, AND ONCE THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE COIL INDEED DETACHED. A MICRO SNARE WAS SUCCESSFULLY UTILIZED TO REMOVE IT FROM PATIENT'S BODY. THE PATIENT WAS IN GOOD HEALTH. THE DOCTOR FOLLOWED (IFU) INSTRUCTION FOR USE. NO ADVERSE EVENT WAS REPORTED. THE PHYSICIAN INDICATED THAT THE EVENT OCCURRED BECAUSE, THE 2 CATHETER TECHNIQUE, AND THE 2 CATHETER WERE SUPPOSED TO BE FIXED BUT ADMITTED THAT HE MIS-CONTROLED THE EXCELSIOR 10 MC JUST ONCE. TWO (MC) MICROCATHETER TECHNIQUES WAS UTILIZED BY ADVANCING AN AGILITY 14 (GW) GUIDEWIRE FIRST AND THEN AN AGILITY 10 GW. THEN, AN EXCELSIOR 10 MICROCATHETER WAS ADVANCED FOLLOWING THE AGILITY 14, AND A PROWLER 14 FOLLOWING THE AGILITY 10. AFTER THE TWO MICROCATHETERS APPROACHED THE ENTRANCE OF THE ANEURYSM, THE AGILITY 14 GW AND EXCELSIOR SL10 WERE CONTROLLED TO MAKE ENOUGH SUPPORT NOT TO MAKE THE COIL GET OUT OF THE ANEURYSM. THEN, THE AGILITY 10 GW WAS ADVANCE AND PROWLER 14 MC TO THE SAC. AFTER RETRIEVING ALL THE GUIDEWIRES WITH ENOUGH SUPPORT OF THE EXCELSIOR MC. THE ANEURYSM WAS LOCATED IN THE BASILAR TIP THAT MEASURED 7MM (SAC DIAMETER), 4MM (NECK LENGTH) AND 8MM (TOP TO BOTTOM). AN ENVOY XB MPA 6FRENCH GUIDE CATHETER, AGILITY 14 & AGILITY 10 GUIDEWIRES, PROWLER 14 MP SHAPE AND AN EXCELSIOR SL-10 45` WERE UTILIZED DURING THE PROCEDURE.
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. | 13471475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |