BASE SYSTEM, ILLUMENA

Additional Manufacturer Narrative

OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON ANGIOMAT ILLUMENA INJECTOR 900001C SERIAL NUMBER: (B)(6) ALLEGING THAT IT FAILED TO INJECT AS INSTRUCTED, RESULTING IN FREQUENT INTERRUPTIONS TO THE SURGERY CAUSING DELAYS IN THE SURGERY AND PATIENT TREATMENT. THE INITIAL REPORT INDICATED THAT THE CONNECTING CABLE BETWEEN THE INJECTOR AND THE DSA WAS NOT PROPERLY INSTALLED. A GUERBET TRAINED SERVICE REP WENT ONSITE TO INVESTIGATE AND CONFIRMED THAT THE INTERFACE CABLE PN: 900251-3 HAD BECOME DAMAGED CAUSING THE DSA START SIGNAL NOT TO BE RECEIVED BY THE INJECTOR. SERVICE ENGINEER REPAIRED THE DAMAGED CONNECTION OF THE INTERFACE CABLE AND THE PROBLEM WAS RESOLVED. THE SYSTEM WAS TESTED FOR PROPER OPERATION AND RETURNED TO CUSTOMER USE. THERE WAS NO REPORTED ISSUE WITH THE ILLUMENA INJECTOR. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO PREVIOUSLY REPORTED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER, BUT A DELAY IN PROCEDURE WAS REPORTED, IMDRF CODES: B01; C02, C0205; D02. ROOT / PROBABLE CAUSE CODE. DEFECTIVE CABLE. 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 RETURNED TO SERVICE.

Description of Event or Problem

THIS CASE WAS REPORTED BY A FACILITY IN DONGYANG, CHINA ON 05 MARCH 2026. THE CUSTOMER STATES THAT ON (B)(6) 2025, DURING SURGERY IN THE INTERVENTIONAL CATHETERIZATION ROOM, THE HIGH-PRESSURE INJECTOR FAILED TO INJECT THE DRUG AS INSTRUCTED, RESULTING IN FREQUENT INTERRUPTIONS TO THE SURGERY, FAILURE TO COMPLETE THE SURGERY AS SCHEDULED, AND DELAYS IN THE SURGERY AND PATIENT TREATMENT. THE HIGH-PRESSURE INJECTOR FAILED TO INJECT THE DRUG AS INSTRUCTED AS THE INJECTOR HAD NO RESPONSE.