COPILOT

Description of Event or Problem

IT WAS REPORTED IN GENERAL COMMENT THAT DURING A PROCEDURE THE SPRING IN THE CAP OF THREE COPILOT DEVICES BECAME STUCK AND DID NOT REBOUND (RELEASE) EASILY. MANUAL ASSISTANCE AND EXTRA FORCE TO PRESS DOWN THE CAPS TO REBOUND (RELEASE). WHEN THE CAPS WERE PRESSED DOWN BLOOD WAS NOTED TO BE LEAKING AND BACKFLOWING INTO THE HUB OF THE DEVICES. THERE WAS NOT ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT LEVEL PRODUCT QUALITY ISSUE. AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. B3: DATE OF PROCEDURE ESTIMATED TO (B)(6) 2024.