COPILOT

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO SIMILAR COMPLAINTS FROM THIS LOT. HOWEVER, THE REPORTED LEAK / SPLASH ISSUE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED LEAK / SPLASH APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE COPILOT DEVICE LEAKED DURING CONTRAST AGENT INJECTIONS FROM THE BLEEDBACK CONTROL SEAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER COPILOT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.