N/A
Received Apr 11, 2026 · Event occurred Mar 26, 2026
Report 3011610434-2026-00008 · MDR key 24852101
Device
Product problems
- Fluid/Blood Leak
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2026, IT WAS REPORTED THAT AN AGILIS FLUSHED FINE OUT OF THE PACKAGE. WHEN IT WAS INTRODUCED INTO THE BODY, MD TRIED TO FLUSH BUT FLUID WAS COMING OUT OF THE SIDE PORT INSTEAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AS A RESULT OF THIS EVENT. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON 30-MARCH-2026. A VISUAL INSPECTION WAS PERFORMED UPON THE DILATOR AND INTRODUCER SHEATH UPON RECEIPT. THE HEMOSTASIS TUBING WAS PARTIALLY TORN FROM THE VALVE HOUSING. THE TUBING REMAINED ATTACHED TO THE VALVE HOUSING. NO OTHER DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED INTRODUCER OR DILATOR. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED TO ENSURE THAT ALL MANUFACTURING AND INSPECTION PROCESS STEPS WERE COMPLETED AND NO ANOMALIES WERE NOTED. BASED ON THE VISUAL INSPECTION RESULTS, THE REPORTED ISSUE IS ABLE TO BE CONFIRMED. AS THE DEVICE MET ALL INSPECTION CRITERIA AT THE TIME OF MANUFACTURING, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DEFINITIVELY DETERMINED.
Description of Event or Problem
ON (B)(6) 2026, IT WAS REPORTED THAT AN AGILIS FLUSHED FINE OUT OF THE PACKAGE. WHEN IT WAS INTRODUCED TO THE BODY, THE PHYSICIAN TRIED TO FLUSH BUT FLUID WAS COMING OUT OF THE SIDE PORT INSTEAD.