ANGIOMAT ILLUMENA

Additional Manufacturer Narrative

OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON ILLUMENA NEO INJECTOR 900001, SERIAL NUMBER (B)(6) ALLEGING AIR IN THE LINE WITH A POSSIBLE BYPASSED STEP DURING A MAMMOGRAPHY PROCEDURE, FOR WHICH THE ILLUMENA NEO IS NOT INTENDED. FURTHER DETAILS WERE PROVIDED STATING THAT THE TUBING WAS DIFFICULT TO REMOVE AND THAT THE INJECTOR WAS PRESENTING THE WARNING MESSAGE OF "WARNING, AIR MAY BE PRESENT! SYRINGE WAS NOT CHANGED AFTER LAST INJECTION. PLEASE INSTALL NEW SYRINGE TO CONTINUE." AFTER RECEIVING THIS WARNING MESSAGE, THE USER POWER CYCLED THE INJECTOR INSTEAD OF INSTALLING NEW SYRINGE OR FOLLOWING STANDARD OPERATING INSTRUCTIONS PER THE IFU. DUE TO THIS POWER CYCLING, THE OPERATOR STATED THAT THEY WERE WASTING CONTRAST MEDIA. WHEN THE OPERATOR OPENS THE FACEPLATE AFTER FULLY RETRACTING THE SYRINGE, CONTRAST SHOOTS OUT OF THE SYRINGE INTO THE TUBING. THIS, AS WELL AS THE DIFFICULT TO REMOVE TUBING IS NOT AN INJECTOR OR CONSUMABLES MALFUNCTION, IT IS LIKELY DUE TO THE NEGATIVE PRESSURE BUILDING UP FROM THE RETRACTION OF THE PLUNGER, ALSO RESULTING FROM OPERATOR ISSUE WITH IMPROPER RETRACTION TECHNIQUE. AN APPLICATIONS SPECIALIST CONTACTED THE OPERATOR AND SUCCESSFULLY WALKED THEM THROUGH HOW TO PROPERLY LOAD A SYRINGE AND SET THE PRESSURE SETTING. THERE WAS NO MALFUNCTION WITH THE INJECTOR, AND THIS WAS A USER RELATED ISSUE IN ADDITION TO OFF-LABEL USE. A REVIEW OF CTS SHOWS NO SIMILAR ISSUE REPORTED ON THIS UNIT. IMPACT ASSESSMENT SUMMARY NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B13, C23, D1101, D1103. ROOT / PROBABLE CAUSE CODE: PROCESS/METHODS - INADEQUATE/INCORRECT PROCEDURE. ROOT / PROBABLE CAUSE SUMMARY. REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT REMAINED IN SERVICE.

Description of Event or Problem

THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON 04 SEPTEMBER 2025. CUSTOMER ALLEGING AIR IN THE LINE WITH A POSSIBLE BYPASSED STEP DURING A MAMMOGRAPHY PROCEDURE. .