N/A
Received Apr 10, 2026 · Event occurred Mar 23, 2026
Report 3011610434-2026-00007 · MDR key 24839822
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 THERE WAS A FAULTY BLEED-BACK VALVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AS A RESULT OF THIS EVENT. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON (B)(6) 2026. A VISUAL INSPECTION WAS PERFORMED UPON THE DILATOR AND INTRODUCER SHEATH UPON RECEIPT. THE HEMOSTASIS TUBING WAS PARTIALLY TORN/CUT FROM THE VALVE HOUSING. NO OTHER DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED INTRODUCER OR DILATOR. LEAK TESTING WAS PERFORMED ON THE DEVICE AND THE DEVICE WAS FOUND TO FAIL LEAK TESTING. THE PROCESS CONTROL RECORD WAS REVIEWED TO ENSURE THAT ALL MANUFACTURING AND INSPECTION PROCESS STEPS WERE PERFORMED AND NO ANOMALIES WERE NOTED. BASED ON THE VISUAL INSPECTION RESULTS, THE REPORTED ISSUE OF A "FAULTY BLEED-BACK VALVE" COULD NOT BE CONFIRMED, HOWEVER, DUE TO THE TEAR/CUT IN THE HEMOSTASIS TUBING AND THE FAILED LEAK, TEST, IT CAN BE CONFIRMED THAT THERE WERE PERFORMANCE ISSUES WITH THE REPROCESSED AGILIS SHEATH. 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 THE DEVICE HAD TO BE EXCHANGED DUE TO A FAULTY BLEEDBACK VALVE. UPON RECEIPT OF THE DEVICE, THERE WAS A SMALL CUT ON THE HEMOSTASIS TUBING NEAR THE HUB.