ORBIT GALAXY DETACHABLE COIL SYSTEM
Report
- Report Number
- 3007628272-2012-50082
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 5, 2012
- Manufacturer
- CODMAN AND SHURTLEFF, INC
- Product Code
- HCG
- PMA / PMN Number
- K093973
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT GALAXY (640CF0824/15694298) WOULD NOT DETACH AT THE GREEN ZONE USING AN UNSPECIFIED DCS SYRINGE II. IT IS UNKNOWN IF THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THEREFORE, THE ORBIT GALAXY WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ORBIT GALAXY (CATALOG AND LOT UNKNOWN) THAT COULD BE DETACHED WITHOUT ANY DIFFICULTIES. HOWEVER, WHEN DELIVERY SYSTEM WAS PULLED BACK, ABOUT 10CM FROM THE PROXIMAL END OF THE DELIVERY TUBE APPEARED TO BE DAMAGED AND SEPARATED IN TWO PIECES. THE DISTAL PIECE OF THE DELIVERY TUBE WAS FOUND IN THE PROGREAT (MC) MICROCATHETER AND WAS ALSO SAFELY REMOVED. IT IS UNKNOWN WHERE AND WHEN EXACTLY IT WAS OCCURRED. THE DEVICE WAS NOT SEPARATED OR DAMAGED PRIOR TO USE, AND THERE WAS NO RESISTANCE DURING DELIVERY OF THE DEVICE THROUGH THE INTRODUCER, Y CONNECTOR OR MICROCATHETER. IT IS UNKNOWN IF THE SAME DCS SYRINGE II WAS USED WITH THE NEXT DEVICE, AND ALSO UNKNOWN HOW MANY OTHER COILS WERE DETACHED WITH THE SAME SYRINGE. PRIOR TO THE ORBIT GALAXY-640CF0824/15694298, THE SYRINGE WAS TAKING PASSED THE GREEN ZONE, BUT IS UNKNOWN HOW MANY TIMES. A DEDICATED SALINE SOURCE WAS USED TO FILL THE SYRINGE, AND ALL THE CONNECTIONS WERE CHECKS FOR PROPER FITTING. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATION WAS REPORTED. PRIOR TO THE COMPLAINT PRODUCT, NINE COILS WERE PLACED IN THE ANEURYSM WITHOUT ANY DIFFICULTIES. IT IS ALSO UNKNOWN BOTH THE DCS SYRINGE II AND THE PROGREAT MC (TERUMO, UNSPECIFIED) WERE REPLACED OR NOT. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE TARGET SITE WAS INTERNAL ILIAC ARTERY PRIOR TO STENT GRAFTING THAT WAS MILDLY CALCIFIED AND HEAVILY TORTUOUS. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION, BUT NOT THE ORBIT THAT SEPARATED. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE ORBIT GALAXY TIGHT DISTAL LOOP COMPLEX FILL COIL 8 X 24 WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND SEPARATED. THERE WERE ALSO KINKS FOUND. THE INTRODUCER WAS UNZIPPED AND KINKED. THE COIL, GRIPPER AND SUPPORT COIL WERE RECEIVED OUTSIDE THE INTRODUCER. SUPPORT COILS AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE COIL WAS FOUND STRETCHED. SOME WAVES WERE FOUND ON THE PRODUCT BUT APPARENTLY CAN OCCUR DURING THE HANDLING OF THE UNIT WHEN THIS WAS RETURNED FOR EVALUATION. THE GRIPPER AND COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE AND DIDN'T PRESENT ANY OCCLUSION IN THE PURGE-HOLE AREA. THE COIL WAS STRETCHED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATION IN THE HYPOTUBE. 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 DAMAGES FOUND ON THE RETURNED DEVICE MAY HAVE OCCURRED DURING THE SHIPPING PROCESS, SINCE IT WAS REPORTED THAT THERE WERE NO DAMAGES ON THE DEVICE. THE REPORTED FAILURE TO DETACH COULD NOT BE EVALUATED. DUE TO THE DAMAGES NO FUNCTIONAL TESTING COULD BE CONDUCTED, BUT NO OCCLUSION WAS NOTED IN THE PURGE-HOLE. ADDITIONALLY, NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT IT COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY, INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES FROM LEAVING THE FACILITY. THE FOUND DAMAGES APPEAR TO BE HANDLING RELATED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 3007628272-2012-50082 AND 3007628272-2012-50083.
A NON-STERILE ORBIT GALAXY TIGHT DISTAL LOOP COMPLEX FILL COIL 8 X 24 WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND SEPARATED. THERE WERE ALSO KINKS FOUND. THE INTRODUCER WAS UNZIPPED AND KINKED. THE COIL, GRIPPER AND SUPPORT COIL WERE RECEIVED OUTSIDE THE INTRODUCER. SUPPORT COILS AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE COIL WAS FOUND STRETCHED. SOME WAVES WERE FOUND ON THE PRODUCT BUT APPARENTLY CAN OCCUR DURING THE HANDLING OF THE UNIT WHEN THIS WAS RETURNED FOR EVALUATION. THE GRIPPER AND COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE AND DIDN'T PRESENT ANY OCCLUSION IN THE PURGE HOLE AREA. THE COIL WAS STRETCHED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATION IN THE HYPOTUBE. 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 FAILURE UNABLE TO DETACH COULD NOT BE EVALUATED DUE TO THE HYPOTUBE WAS RECEIVED SEPARATED/BROKEN, AND THE DELIVERY TUBE SEPARATED-DURING USE WAS CONFIRMED DURING THE VISUAL ANALYSIS. THE EDGES OF THE BROKEN SECTION OF THE HYPOTUBE APPEAR AS IT WAS KINKED BEFORE IT WAS BROKEN. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT IT COULD BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF FAILURES FROM LEAVING THE FACILITY. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 3007628272-2012-50082 AND 3007628272-2012-50083.
THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE TARGET SITE WAS INTERNAL ILIAC ARTERY PRIOR TO STENT GRAFTING THAT WAS MILDLY CALCIFIED AND HEAVILY TORTUOUS. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION, BUT NOT THE ORBIT THAT SEPARATED. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 15694298 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 3007628272-2012-50082 AND 3007628272-2012-50083.
DURING THE PROCEDURE, THE ORBIT GALAXY COIL ((B)(4)) WOULD NOT DETACH USING AN UNSPECIFIED SYRINGE (CATALOGUE/LOT UNKNOWN), AND THEN IT WAS DECIDED TO RETRIEVE THE DEVICE FROM THE PATIENT. HOWEVER, WHILE HE WAS PULLING THE COIL BACK, ABOUT 10CM FROM THE PROXIMAL END OF THE DELIVERY TUBE WAS DAMAGED AND SEPARATED IN TWO PIECES INTO THE PROGREAT MICROCATHETER (TERUMO, TYPE UNKNOWN). THE REPORT DID NOT INDICATE WHY AND HOW THE DAMAGE OCCURRED. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON PRODUCT BY VISUAL INSPECTION. THEN, BOTH THE ENTIRE ORBIT GALAXY AND THE MICROCATHETER WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THE ORBIT GALAXY WAS REPLACED FOR A NEW PRODUCT ((B)(4), LOT UNKNOWN). THEN, THE REPLACED ORBIT GALAXY WAS SUCCESSFULLY PLACED IN THE TARGET VESSEL WITHOUT ANY DIFFICULTIES. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ISSUES. NO PATIENT INJURY/COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THE SYRINGE AND THE MICROCATHETER WERE REPLACED OR NOT. IT IS ALSO UNKNOWN HOW MANY COILS WERE DETACHED USING THE SAME SYRINGE. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE TARGET SITE WAS INTERNAL ILIAC ARTERY PRIOR TO STENT GRAFTING THAT WAS MILDLY CALCIFIED AND HEAVILY TORTUOUS. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION, BUT NOT THE ORBIT THAT SEPARATED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4): A NON-STERILE ORBIT GALAXY TIGHT DISTAL LOOP COMPLEX FILL COIL 8 X 24 WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND SEPARATED. THERE WERE ALSO KINKS FOUND. THE INTRODUCER WAS UNZIPPED AND KINKED. THE COIL, GRIPPER AND SUPPORT COIL WERE RECEIVED OUTSIDE THE INTRODUCER. SUPPORT COILS AND GRIPPER WERE FOUND WITHOUT DAMAGE. THE COIL WAS FOUND STRETCHED. SOME WAVES WERE FOUND ON THE PRODUCT BUT APPARENTLY CAN OCCUR DURING THE HANDLING OF THE UNIT WHEN THIS WAS RETURNED FOR EVALUATION. THE GRIPPER AND COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE AND DIDN'T PRESENT ANY OCCLUSION IN THE PURGE HOLE AREA. THE COIL WAS STRETCHED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATION IN THE HYPOTUBE. 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 FAILURES OF FAILURE TO DETACH AND SEPARATED DELIVERY TUBE COULD NOT BE EVALUATED. THE CAUSE OF THE FAILURES REPORTED ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. THE FAILURE TO DETACH COULD BE PRODUCED BY THE FOUND DAMAGE/SEPARATION IN THE HYPOTUBE. HOWEVER, NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT IT COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY, INSPECTIONS ARE IN PLACED THAT PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THE FOUND DAMAGES APPEAR TO BE HANDLING RELATED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT GALAXY (640CF0824/15694298) WOULD NOT DETACH AT THE GREEN ZONE USING AN UNSPECIFIED DCS SYRINGE II. IT IS UNKNOWN IF THE ALTERNATIVE DETACHMENT WAS ATTEMPTED. THEREFORE, THE ORBIT GALAXY WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ORBIT GALAXY (CATALOG AND LOT UNKNOWN) THAT COULD BE DETACHED WITHOUT ANY DIFFICULTIES. HOWEVER, WHEN DELIVERY SYSTEM WAS PULLED BACK, ABOUT 10CM FROM THE PROXIMAL END OF THE DELIVERY TUBE APPEARED TO BE DAMAGED AND SEPARATED IN TWO PIECES. THE DISTAL PIECE OF THE DELIVERY TUBE WAS FOUND IN THE PROGREAT (MC) MICROCATHETER AND WAS ALSO SAFELY REMOVED. IT IS UNKNOWN WHERE AND WHEN EXACTLY IT WAS OCCURRED. THE DEVICE WAS NOT SEPARATED OR DAMAGED PRIOR TO USE, AND THERE WAS NO RESISTANCE DURING DELIVERY OF THE DEVICE THROUGH THE INTRODUCER, Y CONNECTOR OR MICROCATHETER. IT IS UNKNOWN IF THE SAME DCS SYRINGE II WAS USED WITH THE NEXT DEVICE, AND ALSO UNKNOWN HOW MANY OTHER COILS WERE DETACHED WITH THE SAME SYRINGE. PRIOR TO THE ORBIT GALAXY-640CF0824/15694298, THE SYRINGE WAS TAKING PASSED THE GREEN ZONE, BUT IS UNKNOWN HOW MANY TIMES. A DEDICATED SALINE SOURCE WAS USED TO FILL THE SYRINGE, AND ALL THE CONNECTIONS WERE CHECKS FOR PROPER FITTING. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATION WAS REPORTED. PRIOR TO THE COMPLAINT PRODUCT, NINE COILS WERE PLACED IN THE ANEURYSM WITHOUT ANY DIFFICULTIES. IT IS ALSO UNKNOWN BOTH THE DCS SYRINGE II AND THE PROGREAT MC (TERUMO, UNSPECIFIED) WERE REPLACED OR NOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORBIT GALAXY DETACHABLE COIL SYSTEM | ARTIFICIAL EMBOLIZATION DEVICE | HCG | CODMAN AND SHURTLEFF, INC | NA | 15694298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DCS SYRINGE II AND PROGREAT MICROCATHETER |