COPILOT
Received May 26, 2026 · Event occurred May 7, 2026
Report 2024168-2026-02126 · MDR key 25284261
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
1003331Catalog number
1003331
Lot number
60689490
Product problems
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) LEUR LOCK KEPT LEAKING. 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.