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 DURING THE PROCEDURE, THE COPILOT WAS NOTED TO BE LEAKING BLOOD, MAKING IT DIFFICULT FOR THE PHYSICIAN TO MANIPULATE THE DEVICES AND HAVE VISIBILITY ON ALL THE DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED LEAK/SPLASH WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. AS THE REPORTED LEAK WAS UNABLE TO BE FUNCTIONALLY TESTED DURING RETURN ANALYSIS, IT IS POSSIBLE THAT THE CAP SEAL WAS NOT FULLY TIGHTENED RESULTING IN THE REPORTED LEAK DIFFICULTIES; HOWEVER, THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.