STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)) WAS COMPLETED ON MARCH 4, 2025 BY THE THIRD PARTY SERVICE PROVIDER, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION. THE CUSTOMER DISCARDED THE SUSPECT DISPOSABLES AT THE TIME OF THE INCIDENT; HOWEVER, THEY WERE ABLE TO PROVIDE A LOT NUMBER FOR THE STELLANT DISPOSABLE KIT. THE TESTING OF A RETAINED SAMPLE IS PENDING. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS MARCH 3, 2011 WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF SEPTEMBER 24, 2016 FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: A 74 YEAR OLD FEMALE PATIENT WAS REFERRED TO A RADIOLOGY IMAGING CLINIC FOR AN ENHANCED CT SCAN TO EXCLUDE DISTANT OR NODAL DISEASE FOLLOWING A RESECTED STAGE IIIB MELANOMA. THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER 35676) AND 62ML OMNIPAQUE 350 INTRAVENOUS CONTRAST WAS ADMINISTERED. FOLLOWING THE INJECTION, A MODERATELY LARGE VOLUME (NOT QUANTIFIED) OF VENOUS GAS WAS VISUALIZED ON THE DISPLAYED IMAGES WITHIN THE RIGHT SUBCLAVIAN VEIN, BRACHIOCEPHALIC VEIN, LEFT INTERNAL AND EXTERNAL JUGULAR VEINS AND RIGHT ATRIUM. THE PATIENT WAS REPORTED TO HAVE BEEN SYMPTOMATIC WITH CHEST PAIN AND COUGH AND WAS PLACED IN LEFT LATERAL DECUBITUS TRENDELENBURG POSITION AND OXYGEN WAS ADMINISTERED. REPEAT CT SCAN SHOWED RESOLUTION OF THE PREVIOUSLY VISIBLE INTRAVASCULAR GAS. ACCORDING TO THE CUSTOMER, THE PATIENT REMAINED SYMPTOMATIC (NORMAL O2 SATURATION AND PULSE, INITIALLY HYPERTENSIVE BUT IMPROVED). AS THIS INCIDENT OCCURRED AT AN OUTPATIENT RADIOLOGY IMAGING CLINIC, THE PATIENT WAS SUBSEQUENTLY TRANSFERRED A NEARBY HOSPITAL FOR FURTHER MONITORING. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC THE FOLLOWING DAY AND WAS DISCHARGED WITH NO ONGOING ILL EFFECTS. NOTE: THIS EVENT OCCURRED ON FEBRUARY 18, 2025. HOWEVER, BAYER MEDICAL CARE INC. WAS NOT NOTIFIED UNTIL RECEIPT OF AN INCIDENT NOTIFICATION FROM THE THIRD-PARTY SERVICE PROVIDER SUPERVISOR (TECHNISONIC) ON MARCH 5, 2025.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE STELLANT CT INJECTOR (SERIAL NUMBER (B)(6) WAS COMPLETED ON MARCH 4, 2025, BY THE THIRD-PARTY SERVICE PROVIDER, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION. THE CUSTOMER DISCARDED THE SUSPECT DISPOSABLES AT THE TIME OF THE INCIDENT; HOWEVER, THEY WERE ABLE TO PROVIDE A LOT NUMBER FOR THE STELLANT DISPOSABLE KIT. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED A RETAINED SAMPLE OF THE MEDRAD® STELLANT SDS-CTP-SPK, LOT NUMBER 8635241, DISPOSABLE KIT. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLE PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. ADDITIONAL INFORMATION RECEIVED FOUND THAT THE CUSTOMER USED A THIRD-PARTY MULTI-PATIENT TUBING SET WHICH WAS CONNECTED TO THE BAYER SINGLE USE STELLANT® SYRINGE KIT OVER A 12-HOUR PERIOD WITH THE THIRD-PARTY PATIENT LINE BEING CHANGED BETWEEN EACH PATIENT. THE STELLANT® STERILE DISPOSABLE SYRINGE KIT INSTRUCTIONS FOR USE STATES THE FOLLOWING: THE DISPOSABLE DEVICES HAVE BEEN DESIGNED AND VALIDATED FOR SINGLE USE ONLY. RE-USE OF THE SINGLE USE DISPOSABLE DEVICES POSE RISKS OF DEVICE FAILURE AND RISKS TO THE PATIENT. POTENTIAL DEVICE FAILURE INCLUDES SIGNIFICANT COMPONENT DETERIORATION WITH EXTENDED USE, COMPONENT MALFUNCTION, AND SYSTEM FAILURE. POTENTIAL RISKS TO THE PATIENT INCLUDE INJURY DUE TO DEVICE MALFUNCTION OR INFECTION AS THE DEVICE HAS NOT BEEN VALIDATED TO BE CLEANED OR RE-STERILIZED. INDICATIONS FOR USE: THE CONTENTS OF THIS PACKAGE ARE INTENDED FOR SINGLE-USE ON ONE PATIENT ONLY WITH MEDRAD® STELLANT INJECTORS. CONTRAINDICATIONS: THESE DEVICES ARE NOT INTENDED FOR MULTIPLE PATIENT USE. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. ENSURE PATIENT IS NOT CONNECTED WHILE PURGING AIR FROM SYRINGE OR ENGAGING OR ADVANCING PLUNGER. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED THE RESPONSIBILITY OF FILLING THE SYRINGE(S). DO NOT CHANGE OPERATORS DURING THE PROCEDURE. IF AN OPERATOR CHANGE MUST OCCUR, ENSURE THAT THE NEW OPERATOR VERIFIES THAT THE FLUID PATH IS PURGED OF AIR. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. NOTE: THE MANUFACTURE DATE FOR THIS DEVICE IS MARCH 3, 2011 WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF SEPTEMBER 24, 2016 FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT YET REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME.

Description of Event or Problem

THE CUSTOMER REPORTED THE FOLLOWING: A 74-YEAR-OLD FEMALE PATIENT WAS REFERRED TO A RADIOLOGY IMAGING CLINIC FOR AN ENHANCED CT SCAN TO EXCLUDE DISTANT OR NODAL DISEASE FOLLOWING A RESECTED STAGE IIIB MELANOMA. THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6) AND 62ML OMNIPAQUE 350 INTRAVENOUS CONTRAST WAS ADMINISTERED. FOLLOWING THE INJECTION, A MODERATELY LARGE VOLUME (NOT QUANTIFIED) OF VENOUS GAS WAS VISUALIZED ON THE DISPLAYED IMAGES WITHIN THE RIGHT SUBCLAVIAN VEIN, BRACHIOCEPHALIC VEIN, LEFT INTERNAL AND EXTERNAL JUGULAR VEINS AND RIGHT ATRIUM. THE PATIENT WAS REPORTED TO HAVE BEEN SYMPTOMATIC WITH CHEST PAIN AND COUGH AND WAS PLACED IN LEFT LATERAL DECUBITUS TRENDELENBURG POSITION AND OXYGEN WAS ADMINISTERED. REPEAT CT SCAN SHOWED RESOLUTION OF THE PREVIOUSLY VISIBLE INTRAVASCULAR GAS. ACCORDING TO THE CUSTOMER, THE PATIENT REMAINED SYMPTOMATIC (NORMAL O2 SATURATION AND PULSE, INITIALLY HYPERTENSIVE BUT IMPROVED). AS THIS INCIDENT OCCURRED AT AN OUTPATIENT RADIOLOGY IMAGING CLINIC, THE PATIENT WAS SUBSEQUENTLY TRANSFERRED A NEARBY HOSPITAL FOR FURTHER MONITORING. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC THE FOLLOWING DAY AND WAS DISCHARGED WITH NO ONGOING ILL EFFECTS. NOTE: THIS EVENT OCCURRED ON FEBRUARY 18, 2025. HOWEVER, BAYER MEDICAL CARE INC. WAS NOT NOTIFIED UNTIL RECEIPT OF AN INCIDENT NOTIFICATION FROM THE THIRD-PARTY SERVICE PROVIDER SUPERVISOR (TECHNISONIC) ON MARCH 5, 2025.