TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
Report
- Report Number
- 1058196-2011-00125
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 17, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
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 15196965 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. COIL ASSY LOT # 15191192 WAS REVIEWED. IT WAS OBSERVED DURING REVIEW OF THIS LOT NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED EVENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00125 AND 1058196-2011-00126. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2011-00125 AND 1058196-2011-00126. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING THE PROCEDURE, THE ORBIT RDFL COMPLEX MINI COILS ((B)(4)) STRETCHED DURING PLACEMENT. THE DEVICES WERE REMOVED WITH THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH SIMILAR DEVICES. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE STRYKER SL10/45 (MC) MICROCATHETER AT ALL TIMES. THE MC WAS NOT RE-SHAPED PRIOR TO USE. NO RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER, AND NO KINKS WERE NOTED IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL/DELIVERY SYSTEM HAD BEEN ADVANCED OUT OF THE DISTAL END OF THE MICROCATHETER. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCK TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. DURING REPOSITIONING, THE COILS WERE LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COILS WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS ZIPPED AND PRESENTED NO DAMAGES. SUPPORT COIL, GRIPPER AND PART OF THE EMBOLIC COIL WERE INSIDE OF IT. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED AT THE PROXIMAL SIDE. SOME WAVES WERE NOTED IN THE DEVICE; HOWEVER THESE APPEAR TO HAVE OCCURRED DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. NO OTHER DAMAGES WERE NOTED. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED NO DAMAGES WHILE THE EMBOLIC COIL WAS STRETCHED AT PROXIMAL SIDE. 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 15196965 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED STRETCHED COILS WERE CONFIRMED. IT WAS REPORTED THAT DURING PLACEMENT, THE MICROCATHETER WAS REPOSITIONED OVER THE COIL. THE INSTRUCTIONS FOR USE CAUTIONS THAT REPOSITIONING THE INFUSION CATHETER WHILE THE COIL IS DEPLOYED MAY LEAD TO DAMAGE AND/OR PREMATURE DETACHMENT OF THE EMBOLIC COIL. BASED ON THE AVAILABLE INFORMATION AND REPORT OF NO DAMAGES PRIOR TO REPOSITIONING IT WOULD APPEAR THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE DAMAGE. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE LEAVING FROM THE FACILITY. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00125 & 1058196-2011-00126.
A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. INTRODUCER WAS ZIPPED AND PRESENTED NO DAMAGES. SUPPORT COIL, GRIPPER AND PART OF THE EMBOLIC COIL WERE INSIDE OF IT. EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS STRETCHED AT PROXIMAL SIDE. SOME WAVES WERE NOTED IN THE DEVICE; HOWEVER THESE APPEAR TO OCCUR DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. NO OTHER DAMAGES WERE NOTED. GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND GRIPPER PRESENTED NO DAMAGES WHILE THE EMBOLIC COIL WAS STRETCHED AT PROXIMAL SIDE. 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 15196965 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. REPORTED FAILURE BY THE CUSTOMER AS "COIL STRETCHED" WAS CONFIRMED. THE CAUSE OF THE COIL STRETCHED COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THESE NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS DUE TO ACCORDING (B)(4) INVESTIGATION THE CUSTOMER STATE THAT "NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED", WHICH INDICATE THAT PROCEDURAL AND HANDLING FACTORS COULD BE CONTRIBUTED TO THIS DAMAGE. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF DAMAGE LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00125 & 1058196-2011-00126. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
DURING THE PROCEDURE, THE ORBIT RDFL COMPLEX MINI COILS (638MF0407/ 638MF0410) STRETCHED DURING PLACEMENT AND THE SAME PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE STRYKER SL10/45 (MC) MICROCATHETER AT ALL TIMES. THE MC WAS NOT RE-SHAPED PRIOR TO USE. NO RESISTANCE OCCURRED WHEN THE COIL WAS INSERTED IN THE MICROCATHETER, AND NO KINKS WERE NOTED IN THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL/DELIVERY SYSTEM MADE OUT OF THE DISTAL END OF THE MICROCATHETER. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAS LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. DURING REPOSITIONING, THE COILS WERE LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED WITH ANY OTHER SECTION OF THE DEVICES, AND THE COILS WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THE PROCEDURE WAS COMPLETED WITH SIMILAR DEVICE.
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 | 15196965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SL 10 45 MICROCATHETER |