XTRASOFT ORBIT GALAXY DETACHABLE COIL
Report
- Report Number
- 3007628272-2012-50087
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 4, 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
THERE WAS SEVERE RESISTANCE WHILE DELIVERING THE GALAXY COIL SYSTEM (640CX0306/15467442) AT ABOUT 10CM FROM THE DISTAL END OF THE MICROCATHETER (EXCELSIORSL10/STRYKER). THEREFORE, IT WAS RETRIEVED ONCE AND THE SAME GALAXY WAS RE-INSERTED IN THE SAME MICROCATHETER BUT THERE WAS STILL SEVERE RESISTANCE IN THE SAME AREA. THE GALAXY WAS THEN SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ONE WITHOUT LOSS OF TARGET SITE POSITION. IT IS UNKNOWN IF THE MICROCATHETER WAS REPLACED OR NOT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COIL OF THE RETURNED DEVICE WAS WITHIN THE INTRODUCER AND STRETCHED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE ORBIT GALAXY COMPLEX XTRASOFT COIL 3 X 6 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND THE EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER, THE SUPPORT COIL AN GRIPPER WERE FOUND WITHOUT DAMAGED WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. ONE PROWLER SELECT PLUS LAB SAMPLE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO), AFTER THAT THE RECEIVED ORBIT GALAXY WAS INTRODUCED INTO THE MICROCATHETER AND EVEN WITH THE KINK FOUND ON THE ORBIT GALAXY PRODUCT IT CAN PASS THROUGH THE LAB SAMPLE MICROCATHETER. IT ADVANCED SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP WHERE SLIGHT FRICTION WAS FELT WHEN THE KINK OF THE HYPOTUBE WAS PASSED THROUGH OF THE LAB SAMPLE. 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 RESISTANCE/FRICTION WAS CONFIRMED WITH FUNCTIONAL TESTING AND WITH FUNCTIONAL TESTING IT WAS DUE TO THE KINK FOUND ON THE DEVICE. IF THE KINK WAS PRESENT DURING PROCEDURAL USE, IT APPEARS THAT THIS MAY HAVE BEEN THE CAUSE OF THE RESISTANCE. IT IS ALSO POSSIBLE THAT THE CONCOMITANT MICROCATHETER MAY HAVE CONTRIBUTED TO THE RESISTANCE; HOWEVER, WITHOUT THE RETURN OF THIS DEVICE FOR FUNCTIONAL TESTING NO CONCLUSION CAN BE MADE. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF STRETCHING OF THE COIL WITHIN THE MICROCATHETER; HOWEVER, BASED ON THE RECEIPT OF THE COIL RECAPTURED WITHIN THE INTRODUCER, THE TIMING AS RELATED TO PROCEDURAL USE AND CAUSE OF THE STRETCHED CONDITION OF THE COIL CANNOT BE DETERMINED. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE NO DAMAGES ON THE DEVICE WITH VISUAL INSPECTION PRIOR TO USE. IT APPEARS THAT PROCEDURAL FACTORS LIKELY CONTRIBUTED TO THE EVENT AND DAMAGES NOTED ON THE RETURNED DEVICE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
A NON-STERILE ORBIT GALAXY COMPLEX XTRASOFT COIL 3 X 6 WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND THE EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER, THE SUPPORT COIL AN GRIPPER WERE FOUND WITHOUT DAMAGED WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE; THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION ACCORDING TO DOCUMENT ES05094 REV 8 AND ES05098 REV 15. ONE MICROCATHETER PROWLER SELECT PLUS (CORDIS LAB SAMPLE) WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO), AFTER THAT THE RECEIVED ORBIT GALAXY WAS INTRODUCED INTO THE MICROCATHETER AND EVEN THE KINK FOUND ON THE ORBIT GALAXY PRODUCT IT CAN PASS THROUGH OF THE MICROCATHETER LAB SAMPLE AND IT WAS ADVANCED SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP. SLIGHTLY FRICTION WAS FELT WHEN THE KINK OF THE HYPOTUBE WAS PASSED THROUGH OF THE MICROCATHETER LAB SAMPLE. 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 CONFIRMED DURING THE FUNCTIONAL ANALYSIS. THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER APPEARS WAS DUE TO THE KINK FOUND ON THE DEVICE. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES DUE TO AS PER CH&SS INVESTIGATION THE CUSTOMER STATE THAT "PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION." ADDITIONALLY INSPECTIONS ARE IN PLACE (REFER (B)(4)) TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.
THE PROCEDURE WAS COIL EMBOLIZATION FOR ANTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. THE EVENT HAPPENED DURING COIL INTRODUCTION. IT WAS NOTED WHILE DELIVERING THE GALAXY (640CX0306/15467442, COMPLAINT PRODUCT) THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE ABOUT 10CM FROM THE DISTAL END OF MICROCATHETER (EXCELSIORSL10/STRYKER). THEREFORE THE PHYSICIAN ONCE RETRIEVED THE GALAXY AND RE-INSERTED THE SAME GALAXY IN THE SAME MICROCATHETER BUT HE STILL EXPERIENCED SEVERE RESISTANCE AT THE SAME PART. THEN, THE GALAXY WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ONE. IT IS UNKNOWN IF THE MICROCATHETER WAS ALSO REPLACED OR NOT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE INDICATED THAT DURING RE-INSERTING OF THE COIL, THERE WAS NO LOSS OF TARGET POSITION IN THE INTRA-CRANIAL VASCULATURE. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE ENTIRE COIL WAS WITHDRAWN FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XTRASOFT ORBIT GALAXY DETACHABLE COIL | ARTIFICIAL EMBOLIZATION DEVICE | HCG | CODMAN AND SHURTLEFF, INC | NA | 15467442 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN EXCELSIORSL10/STRYKER MICROCATHETER |