COPILOT

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 WERE NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. IN THIS CASE, IT IS POSSIBLE THAT THE CAP SEAL WAS NOT FULLY TIGHTENED, THEREFORE RESULTING IN THE REPORTED LEAK DIFFICULTIES. HOWEVER, THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, IT CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE COPILOT ROTATING HEMOSTATIC VALVE (RHV) WAS CONNECTED TO THE INDEFLATOR, A LEAK WAS NOTED AROUND THE ROTATOR AND AIR ENTERED THE INDEFLATOR. THE PHYSICIAN WAS ABLE TO CATCH THE AIR BUBBLES BEFORE THEY WERE INJECTED INTO THE GUIDING CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.