PROWLER MICROCATHETERS
Report
- Report Number
- 1058196-2011-00163
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 30, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- KRA
- PMA / PMN Number
- K993266
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 15058577 THE FOLLOWING WAS FOUND. A 20 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE ENTERPRISE STENT PRE-DEPLOYED AT THE PROWLER SELECT PLUS MICROCATHETER HUB. AFTER THE EVENT IT IS UNKNOWN IF THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE OR IF A GUIDEWIRE WAS UTILIZED TO EXCHANGE THE MICROCATHETER TO MAINTAINED TARGET SITE. PRIOR AND AFTER REMOVAL FROM THE PACKAGE, THE PRODUCTS WERE DAMAGED. ALL THE PRODUCTS WERE PREPPED PER LABELING INSTRUCTIONS. THE DISTAL TIP OF THE ENTERPRISE DELIVERY SYSTEM WAS NOT RE-SHAPED. THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB. THE Y CONNECTOR OR TOUHY WAS CLOSED AFTER THE INTRODUCER WAS CORRECTLY SEATED IN THE HUB TO PREVENT MOVEMENT. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. AFTER REMOVAL, THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER OR ENTERPRISE SYSTEM. NO FURTHER INFORMATION IS AVAILABLE. A NON-STERILE PROWLER PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. DEVICE WAS INSPECTED AND KINKS AND FLATTENED SECTIONS WERE NOTED. NO ANOMALIES WERE NOTED IN THE HUB. HUB ID WAS INSPECTED UNDER MICROSCOPE AND NO ANOMALIES WERE OBSERVED THE ID OF THE MICROCATHETER WAS MEASURED AND WAS WITHIN SPECIFICATION. THE STENT OF THE CONCOMITANT ENTERPRISE VRD WAS RECEIVED DEPLOYED; THEREFORE, THE PROWLER PLUS MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE, THEN USING A Y CONNECTOR A LAB SAMPLE ENTERPRISE VRD SYSTEM WAS INSERTED INTO THE MICROCATHETER AND IT COULD PASS THROUGH THE HUB WITHOUT ANY RESISTANCE. THE ENTERPRISE BECAME STUCK IN THE DISTAL MICROCATHETER SHAFT DUE TO FLATTENED SECTIONS OF THE MICROCATHETER. ADDITIONALLY IT WAS CONFIRMED THAT THE RETURNED ENTERPRISE INTRODUCER WAS ABLE TO BE CORRECTLY SEATED IN THE HUB OF THE RETURNED MICROCATHETER. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 15058577 FOUND NO ISSUES RELATED TO THE EVENT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST. FULL FUNCTIONAL TESTING OF INSERTION OF THE ENTERPRISE VRD INTO THE PROWLER SELECT PLUS COULD NOT BE PERFORMED SINCE THE STENT WAS DEPLOYED AS REPORTED. NO DISCREPANCY WITH INSERTION OF LAB SAMPLE ENTERPRISE VRD INTO THE HUB OF THE RETURNED PROWLER SELECT PLUS MICROCATHETER WAS FOUND WITH FUNCTIONAL TESTING. BASED ON THE REPORT THAT THERE WERE NO DAMAGES ON THE MICROCATHETER, THE CAUSE OF THE FLATTENED AREAS NOTED ON THE RETURNED MICROCATHETER DO NOT APPEAR TO BE MANUFACTURING RELATED AND APPEAR TO BE DUE TO POST PROCEDURE HANDLING/PACKAGING FOR RETURN. INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. THESE DAMAGES WOULD NOT HAVE IMPACTED THE REPORTED INABILITY TO INSERT THE ENTERPRISE INTO THE MICROCATHETER HUB. THE INTRODUCTION PROCEDURE OF THE ENTERPRISE VRD IS TECHNIQUE DRIVEN; REQUIRING PROPER ORIENTATION AND POSITIONING OF EACH COMPONENT OF THE SYSTEM. PROPER PLACEMENT AND SECURING OF THE INTRODUCER IN THE MC HUB PROVIDES AN UNINTERRUPTED PASSAGE FOR THE STENT TO MOVE FROM THE INTRODUCER INTO THE MC. THERE WAS NO DISCREPANCY WITH FUNCTIONAL TESTING OF THE RETURNED PROWLER PLUS MICROCATHETER OR WITH SEATING OF THE RETURNED ENTERPRISE INTRODUCER. ALTHOUGH IT WAS REPORTED THAT THE ENTERPRISE INTRODUCER WAS FULLY SEATED, IT IS NOT POSSIBLE FOR THE STENT TO DEPLOY OUTSIDE OF THIS LUMEN UNLESS THERE IS A GAP BETWEEN THE TIP OF THE INTRODUCER AND THE PROXIMAL END OF THE MC LUMEN. IF AFTER FULLY SEATING THE INTRODUCER, IT IS NOT SECURED IN PLACE AS OUTLINED IN THE INSTRUCTIONS FUR USE, THE INTRODUCER WILL MOVE AND THE GAP WILL EXPAND RESULTING IN PREMATURE DEPLOYMENT OF THE STENT IN THE MICROCATHETER HUB. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE ANALYSIS OF THE RETURNED DEVICES AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING DEFECT OR ANOMALY CONTRIBUTING TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
A NON-STERILE PROWLER PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. DEVICE WAS INSPECTED AND KINKS AND FLATTENED SECTIONS WERE NOTED. NO ANOMALIES WERE NOTED IN THE HUB. HUB ID WAS INSPECTED UNDER MICROSCOPE AND NO ANOMALIES WERE OBSERVED THE ID OF THE MICROCATHETER WAS MEASURED AND ACCORDING TO THE DRAWING ES04700 REV.16 WAS WITHIN SPECIFICATION. DEVICE WAS FLUSHED USING A LAB SAMPLE SYRINGE, THEN USING A Y CONNECTOR AN ENTERPRISE CORDIS/CODMAN LAB SAMPLE WAS INSERTED INTO THE MICROCATHETER AND IT COULD PASS THROUGH THE HUB WITHOUT ANY RESISTANCE. STENT STUCK ON THE DISTAL SHAFT DUE TO THE FLATTENED SECTIONS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 15058577 THE FOLLOWING WAS FOUND. (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. REPORTED FAILURE BY THE CUSTOMER AS "LUER HUB OBSTRUCTED" WAS NOT CONFIRMED DURING THE FUNCTIONAL TEST; THE ENTERPRISE COULD PASS THROUGH THE HUB WITHOUT ANY ANOMALY. THE CAUSE OF THE DAMAGES NOTED IN THE DEVICE DOES NOT APPEAR TO BE MANUFACTURING RELATED DUE TO PER (B)(4) INVESTIGATION THE CUSTOMER STATE THAT "PRIOR AND AFTER REMOVAL FROM THE PACKAGE, THE PRODUCTS WERE NOT DAMAGED". IN ADDITION INSPECTION IS IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL FACTORS COULD BE CONTRIBUTED IN THE DAMAGES NOTED AND IN FAILURE EXPERIENCED BY THE CUSTOMER; HOWEVER AT THIS TIME REMAINS INCONCLUSIVELY AND UNDETERMINED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING A COIL EMBOLIZATION PROCEDURE, THE ENTERPRISE STENT PRE-DEPLOYED AT THE PROWLER SELECT PLUS MICROCATHETER HUB. AFTER THE EVENT IT IS UNKNOWN IF THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE OR IF A GUIDEWIRE WAS UTILIZED TO EXCHANGE THE MICROCATHETER TO MAINTAINED TARGET SITE. PRIOR AND AFTER REMOVAL FROM THE PACKAGE, THE PRODUCTS WERE DAMAGED. ALL THE PRODUCTS WERE PREP PER LABELING INSTRUCTIONS. NEITHER MICROCATHETER NOR DISTAL TIP OF THE ENTERPRISE DELIVERY SYSTEM WAS RE-SHAPED. THE ENTERPRISE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB. THE Y CONNECTOR OR TOUHY WAS CLOSED AFTER THE INTRODUCER WAS CORRECTLY SEATED IN THE HUB TO PREVENT MOVEMENT. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. AFTER REMOVAL FROM THE PATIENT, WAS EITHER DEVICE (ENTERPRISE DELIVERY SYSTEM (DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC), STENT (STRUT UPLIFT OR DEFORMED, ETC), OR MICROCATHETER WERE DAMAGED. THE TARGET SITE WAS A NORMAL BASILAR ARTERY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROWLER MICROCATHETERS | CES MICROCATHETERS (KRA) | KRA | CORDIS NEUROVASCULAR, INC. | NA | 15058577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ENTERPRISE |