COPILOT

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H11: THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE COPILOT VALVE DOES NOT CONNECT TO THE ACIST KIT INJECTION SYSTEM FAUCET. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORTS, AN ADDITIONAL COPILOT WAS RECEIVED. THE DEVICE SHOWED SIGNS OF USE AND FAILED TO MAINTAIN A SECURE CONNECTION DURING FUNCTIONAL TESTING. THE ACCOUNT DID NOT REPORT ANY ISSUES WITH THIS DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR ANALYSIS. LOOSE OR INTERMITTENT CONNECTION WAS OBSERVED. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED AN INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WERE NOT REPORTED, AND THE PACKAGING WAS NOT RETURNED. HOWEVER, FURTHER INVESTIGATION WAS INITIATED TO EVALUATE THE COPILOT COMPLAINT REGARDING THE LOOSE OR INTERMITTENT CONNECTION ISSUES. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.