INDEFLATOR
Received Feb 23, 2026 · Event occurred Jan 29, 2026
Report 2024168-2026-00735 · MDR key 24420657
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
1003327Catalog number
1003327
Lot number
60662371
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 COPILOT WOULD NOT CONNECT TO THE CONTRAST DELIVERY SYSTEM. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE COPILOT WOULD NOT CONNECT TO THE CONTRAST DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
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. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO SIMILAR COMPLAINTS FROM THIS LOT. HOWEVER, THE LOOSE OR INTERMITTENT CONNECTION ISSUE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED LOOSE OR INTERMITTENT CONNECTION APPEARS TO BE A POTENTIAL QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.