INDEFLATOR
Received Apr 14, 2026 · Event occurred Mar 23, 2026
Report 2024168-2026-01512 · MDR key 24874835
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
1003327Catalog number
1003327
Lot number
60664178
Product problems
- Leak/Splash
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 UNSPECIFIED LESION. A 20/30 PRIORITY PAK INDEFLATOR WAS USED TO DEPLOY A STENT; HOWEVER, IT WAS NOTED THE INDEFLATOR WAS VERY SLOW TO INFLATE THE BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS 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. B3, B6: DATES ESTIMATED.