COPILOT
Received Feb 23, 2026 · Event occurred Feb 3, 2026
Report 2024168-2026-00736 · MDR key 24420638
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
1003331Catalog number
1003331
Lot number
60680764
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. 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. BASED ON THE 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE COPILOT, BUBBLES WERE NOTED. 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
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE OTHER DEVICE MENTIONED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE COPILOT, BUBBLES WERE NOTED. 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.