COPILOT

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 WAS LEAKING WHEN CONNECTED TO AN UNSPECIFIED DEVICE AND WHEN THE DEVICE WAS TAKEN OUT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THAT THE COPILOT WAS CONNECTED TO A GUIDE WIRE AS WELL AS THE BLEEDBACK CONTROL SEAL NOTED TO BE LEAKING. NO ADDITIONAL INFORMATION WAS PROVIDED.

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. HOWEVER, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED SIMILAR COMPLAINTS FROM THIS LOT, INDICATING THERE IS A POTENTIAL 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.