NIAGARA

Additional Manufacturer Narrative

H11: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, 07:30 PATIENT EXHIBITS ELEVATED BILIRUBIN LEVELS, MEETING INDICATIONS FOR ARTIFICIAL LIVER THERAPY. AN INTENSIVE CARE PHYSICIAN PERFORMED ULTRASOUND-GUIDED VENOUS PUNCTURE FOR RIGHT FEMORAL BLOOD FILTRATION CATHETER PLACEMENT. UNDER ULTRASOUND GUIDANCE, THE INTRODUCER NEEDLE WAS ADVANCED SLOWLY AT A 45-DEGREE ANGLE TOWARD THE UMBILICUS WHILE ASPIRATING CONTINUOUSLY. AFTER APPROXIMATELY 2.0 CM OF ADVANCEMENT, DARK RED BLOOD WAS ASPIRATED. A GUIDEWIRE WAS INSERTED FOR ABOUT 25 CM BUT FAILED TO PASS SMOOTHLY. ULTRASOUND CONFIRMED THE INTRODUCER NEEDLE REMAINED WITHIN THE VASCULAR LUMEN. CONSIDERING THE GUIDEWIRE AS THE CAUSE, IT WAS WITHDRAWN AND FOUND TO HAVE A KINK AT THE TIP. IMMEDIATELY REPLACING IT WITH A DIFFERENT BRAND OF DEEP VEIN GUIDEWIRE ALLOWED SUCCESSFUL INSERTION. THE INTRODUCER NEEDLE WAS THEN WITHDRAWN. AFTER SKIN EXPANSION WITH A DILATOR, A 24 CM DUAL-LUMEN HEMODIALYSIS VENOUS CATHETER WAS PLACED, AND THE GUIDEWIRE WAS COMPLETELY WITHDRAWN. THE PROCEDURE CONCLUDED SUCCESSFULLY.