COPILOT
Received May 28, 2026 · Event occurred May 6, 2026
Report 2024168-2026-02159 · MDR key 25315197
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
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) LUER LOCK KEPT COMING LOOSE AND NOT CONNECTING. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
B3- FOR REPORTING PURPOSES, THE DATE OF PROCEDURE WAS WILL BE ESTIMATED AS 5/06/2026, AS THE PROCEDURES WERE REPORTED TO HAVE TAKEN PLACE DURING THE WEEK OF (B)(6) 2026. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.