N/A
Received Feb 27, 2026 · Event occurred Jan 26, 2026
Report 3011610434-2026-00003 · MDR key 24476368
Device
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ON 29-JAN-2026, INNOVATIVE HEALTH BECAME AWARE OF A REPROCESSED AGILIS NXT STEERABLE INTRODUCER REPORTED TO HAVE LEAKING OUT OF THE VALVE ONCE THE SHEATH WAS PLACED INTO THE BODY, UNACCEPTABLE MANEUVERABILITY, AND THERE WERE BUBBLES IN THE LINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE DEVICE MET ALL INSPECTION CRITERIA AT THE TIME OF MANUFACTURING. AS THE DEVICE MET ALL INSPECTION CRITERIA PRIOR TO DISTRIBUTION AND AN INVESTIGATION INTO THE PHYSICAL DEVICE WAS NOT ABLE TO BE COMPLETED, INNOVATIVE HEALTH CANNOT CONFIRM WHETHER THERE WERE ANY PERFORMANCE ISSUES WITH THE REPROCESSED SHEATH. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
THE DEVICE WAS REPORTED TO HAVE LEAKING OUT OF THE SHEATH ONCE IT WAS PLACED INTO THE BODY. THE MANEUVERABILITY OF THE SHEATH WAS REPORTED TO BE UNACCEPTABLE, AND THERE WERE BUBBLES REPORTED TO BE IN THE LINE.