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Additional Manufacturer Narrative

ON 26-MAY-2026, IT WAS REPORTED THAT THERE WAS A REPROCESSED AGILIS NXT STEERABLE INTRODUCER REPORTED TO HAVE A BROKEN VALVE, BROKEN DEFLECTION OF CURVE. ADDITIONAL INFORMATION WAS PROVIDED ON 27-MAY-2026 THAT THE PHYSICIAN SAW THE BACK BLEEDING AND NOTED THAT THE CURVE WAS BROKEN. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. A DIFFERENT SHEATH WAS OPENED. INNOVATIVE HEALTH LLC RECEIVED THE DEVICE FOR INVESTIGATION AND A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED INTRODUCER SHEATH AND DILATOR. THE HEMOSTASIS SIDEPORT TUBING HAD A SMALL TEAR NEAR THE VALVE HOUSING. THE TUBING REMAINED ATTACHED TO THE HEMOSTASIS HOUSING. A KINK WAS NOTED IN THE INTRODUCER SHEATH SHAFT. NO DAMAGE OR DEFECTS WERE NOTED ON THE HEMOSTASIS VALVE ASSEMBLY. PER THE INSTRUCTIONS FOR USE, THE USER IS INSTRUCTED TO INSPECT THE DEVICE, INCLUDING ITS COMPONENTS, PRIOR TO USE FOR ANY DAMAGE AND TO NOT USE THE DEVICE IF IT IS DAMAGED. A CURVE INSPECTION WAS PERFORMED AND THE DEVICE WAS FOUND TO NOT MEET INNOVATIVE HEALTH ACCEPTANCE CRITERIA FOR CURVE AND DEFLECTION. 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 RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE IS ABLE TO BE CONFIRMED AS THE TEAR IN THE TUBING MAY HAVE CONTRIBUTED TO THE REPORTED BACK BLEEDING. THE REPORTED ISSUE OF THE HEMOSTASIS VALVE BACKBLEEDING COULD NOT BE REPLICATED DURING THE COMPLAINT INVESTIGATION. 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

IT WAS REPORTED THAT THE DEVICE HAD A BROKEN VALVE AND A BROKEN DEFLECTION OF CURVE. FURTHER INFORMATION WAS PROVIDED THAT THE VALVE WAS REPORTED TO BE BACKBLEEDING.