BASE SYSTEM, ILLUMENA

Description of Event or Problem

THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2025. CUSTOMER REPORTS THAT INJECTOR SUDDENLY MALFUNCTIONED AND FAILED TO LINKED, RESULTING IN AN INABILITY TO INJECT CONTRAST AGENT. INJURY: SEVERE INJURY MANIFESTATION: PROLONGED SURGERY TIME DEVICE FAILURE MANIFESTATION: UNUSABLE USAGE PROCESS: THE PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION FOR INTRACRANIAL ANEURYSM UNDER GENERAL ANESTHESIA. DURING THE SURGERY, THE HIGH-PRESSURE INJECTOR SUDDENLY MALFUNCTIONED AND FAILED TO LINKED, RESULTING IN AN INABILITY TO INJECT CONTRAST AGENT. RESTARTING THE DEVICE WAS INEFFECTIVE. THE SURGERY WAS COMPLETED BY MANUALLY USING THE HIGH-PRESSURE INJECTOR TO INJECT DRUGS, PROLONGING THE PATIENT'S ANESTHESIA TIME. EVENT CAUSE ANALYSIS: PRODUCT-RELATED CAUSE (INCLUDING INSTRUCTIONS, ETC.) EVENT CAUSE ANALYSIS DESCRIPTION: SYSTEM FAILURE OF THE HIGH-PRESSURE INJECTOR INITIAL HANDLING SITUATION: CONTACTED ENGINEERS FOR MAINTENANCE.

Additional Manufacturer Narrative

OVERALL INVESTIGATION SUMMARY A COMPLAINT WAS RECEIVED ON AN ILLUMENA INJECTOR 900001C SERIAL NUMBER (B)(6) ALLEGING THE INJECTOR SUDDENLY FAILED TO LINK WITH THE SCANNER RESULTING IN A 2-3 HOUR DELAY IN THE PROCEDURE. REGIONAL SERVICE ENGINEER INVESTIGATED AND FOUND THE ISSUE WAS DUE TO AN ISSUE WITH THE DSA SCANNER AND NOT THE INJECTOR. THE INJECTOR WAS FULLY FUNCTIONAL AND REMAINED IN SERVICE. THERE WAS NO CONSEQUENCE FOR THE PATIENT OR STAFF. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY CONFIRMED THAT THERE WERE NO INJURY TO THE PATIENT OR USERS IMDRF CODES: B01; C19; D14. ROOT / PROBABLE CAUSE CODE. OTHER ROOT / PROBABLE CAUSE SUMMARY REFER TO INVESTIGATION SUMMARY. AS SERVICE FOUND NOTHING WRONG WITH THE DEVICE DURING INVESTIGATION, NO CORRECTIVE ACTION WAS POSSIBLE. ALTHOUGH NO ADDITIONAL CAPA IS 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 REVIEW MEETINGS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY UNIT REMAINED IN SERVICE.