TRUFILL DCS ORBIT MINI COMPLEX FILL

Report

Report Number: 1058196-2013-00030
Event Type: Malfunction
Date Received: February 5, 2013
Date of Event: January 16, 2013
Report Date: January 17, 2013
Manufacturer: CORDIS NEUROVASCULAR, INC.
Product Code: HCG
PMA / PMN Number: K053197
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DURING USE TO TREAT AN INTERNAL CAROTID ANEURYSM, THE LAST COIL, (ORBIT RDFL COMPLEX MINI COIL- (B)(4)) STRETCHED. THEN, THE DEVICE WAS WITHDRAWN, AND CHANGED TO OTHER COILS TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. DURING PLACEMENT, NO ADDITIONAL MANIPULATION OR TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, AND DURING PLACEMENT, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WAS SUPPOSED TO BE RETURNED FOR ANALYSIS, BUT WAS NOT RECEIVED OR RETURNED. 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 15426919 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE AVAILABLE INFORMATION, EXCESSIVE FORCE WITH THE REPORTED PUSHING AND PULLING OF THE COIL FOR PLACEMENT MAY HAVE CONTRIBUTED TO THE STRETCHING OF THE COIL. BASED ON THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES IMPACTING THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 1

DURING USE TO TREAT AN INTERNAL CAROTID ANEURYSM, THE LAST COIL, (ORBIT RDFL COMPLEX MINI COIL- 637MF0201/ 15426919) STRETCHED. THEN, THE DEVICE WAS WITHDRAWN, AND CHANGED TO OTHER COILS TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. DURING PLACEMENT, NO ADDITIONAL MANIPULATION OR TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, AND DURING PLACEMENT, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WAS RETURNED FOR ANALYSIS. A NON-STERILE ORBIT MINI COMPLEX FILL 2X1.5 WAS RECEIVED COILED INSIDE COIL DISPENSER INSIDE OF A POUCH. THE HYPOTUBE WAS INSPECTED AND NO DAMAGES WERE NOTED ON IT. THE INTRODUCER WAS FOUND WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND INSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLI COIL WAS FOUND STRETCHED. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED/KINKED. 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 STRETCHED COIL WAS CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICE. IT IS POSSIBLE THAT PROCEDURAL FACTORS OR HANDLING MAY HAVE CONTRIBUTED WITH THE REPORTED CONDITION; HOWEVER, IT WAS REPORTED THAT THE COIL WAS FOUND STRETCHED PRIOR TO USE IN THE PATIENT AFTER STRETCHING. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT. WITH REVIEW OF THE INFORMATION AND ANALYSIS, NO CONCLUSION CAN BE MADE. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 1

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 15426919 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.

Description of Event or Problem · 1

DURING USE TO TREAT AN INTERNAL CAROTID ANEURYSM, THE LAST COIL, (ORBIT RDFL COMPLEX MINI COIL- 637MF0201/ 15426919) STRETCHED. THEN, THE DEVICE WAS WITHDRAWN, AND CHANGED TO OTHER COILS TO COMPLETE THE PROCEDURE WITH THE SAME MICROCATHETER. DURING PLACEMENT, NO ADDITIONAL MANIPULATION OR TORQUE WAS APPLIED WHILE THE COIL WAS IN THE ANEURYSM, AND DURING PLACEMENT, THE COIL NOT LEFT IN THE ANEURYSM, WHILE THE MICROCATHETER WAS REPOSITIONED. THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC), AND THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
48607	TRUFILL DCS ORBIT MINI COMPLEX FILL	CNV DCS ORBIT (HCG)	HCG	CORDIS NEUROVASCULAR, INC.	NA	15426919

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNKNOWN MICROCATHETER