COPILOT

Description of Event or Problem

USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "PATIENT WAS BROUGHT FOR AN ELECTIVE LAA [LEFT ATRIAL APPENDAGE] OCCLUSION DEVICE. TRANSSEPTAL PUNCTURE PERFORMED. TRANSSEPTAL SHEATH EXCHANGED FOR DEVICE SHEATH. DEVICE SHEATH USES A DEVICE CALLED A COPILOT BLEEDBACK CONTROL VALVE. THE COPILOT BLEEDBACK CONTROL VALVE WAS FOUND TO BE DEFECTIVE. WHEN BLOOD WAS DRAWN BACK, THE BLEEDBACK VALVE INTRODUCED AIR TO THE DEVICE SHEATH, WHICH ULTIMATELY DELIVERED AIR TO THE LEFT ATRIUM, WHICH BROUGHT AIR TO THE CORONARY ARTERIES. TROUBLESHOOTING MANEUVERS WERE PERFORMED, AND ST ELEVATION RESOLVED, WITH THE PATIENT EVENTUALLY BEING SENT TO THE ICU [INTENSIVE CARE UNIT]. USED A MANUAL TUOHY." SUBSEQUENT TO THE MEDWATCH REPORT, IT WAS REPORTED THAT ONE DEVICE WAS IN THE COPILOT BBCV WHEN THE LEAK WAS NOTED. OXYGEN WAS ADMINISTERED TO THE PATIENT TO RESOLVE THE EKG CHANGES. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

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

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 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 WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES

Description of Event or Problem

SUBSEQUENT TO THE MEDWATCH REPORT, IT WAS REPORTED THAT ONE DEVICE WAS IN THE COPILOT BBCV WHEN THE LEAK WAS NOTED. OXYGEN WAS ADMINISTERED TO THE PATIENT TO RESOLVE THE EKG CHANGES. NO ADDITIONAL INFORMATION WAS PROVIDED.