COPILOT

Description of Event or Problem

IT WAS REPORTED THAT 3 COPILOT BBCV WERE ATTEMPTED TO BE USED IN THE PROCEDURE; HOWEVER, AN AIR LEAK WAS NOTED WHEN ATTEMPTING TO USE THE COPILOT DEVICES. DUE TO THE VESSEL CALIBER, THE AIR WAS TRAPPED BETWEEN AN UNSPECIFIED GUIDEWIRE AND UNSPECIFIED CATHETER DURING USE OF ALL THREE COPILOT DEVICES. THEREFORE, THE CRITICAL PORTION OF THE CASE WAS COMPLETED AND ALL CATHETERS AND GUIDEWIRES WERE CAREFULLY WITHDRAWN BACK UNDER DIRECT ASPIRATION. FINAL ANGIOGRAPHIC RUNS DEMONSTRATED NO AIR IN ANY VESSELS OF THE POSTERIOR CIRCULATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. 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. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

Additional Manufacturer Narrative

A VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE DEVICE WAS LEAK TESTED AND MET SPECIFICATIONS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO 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 WAS NOT REPORTED, AND THE PACKAGING WAS NOT RETURNED. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. IN THIS CASE, IT IS POSSIBLE THAT THE CAP SEAL WAS NOT FULLY TIGHTENED THUS RESULTING IN THE REPORTED LEAK; HOWEVER, THIS CANNOT BE CONFIRMED. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED.