MalfunctionDTL
INDEFLATOR
Received Jun 3, 2026 · Event occurred May 19, 2026
Report 2024168-2026-02241 · MDR key 25374472
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
1003327Catalog number
1003327
Lot number
60700619
Product problems
- Leak/Splash
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.
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA). THE INDEFLATOR WAS USED AND FLUID WAS NOTED TO BE LEAKING AND THE NEEDLE PRESSURE DECREASING. ANOTHER INDEFLATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.