STELLANT DUAL CT INJECTOR

Description of Event or Problem

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 61-YEAR-OLD FEMALE UNDERGOING A CT PULMONARY ANGIOGRAM EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (B)(6) . FOLLOWING THE PROCEDURE, THE CUSTOMER REPORTED THAT AIR WAS VIEWED ON THE DISPLAYED IMAGES WITHIN THE PULMONARY ARTERY, RIGHT ATRIUM, RIGHT VENTRICLE, AND BRACHIOCEPHALIC VEIN. THE PATIENT WAS SENT FOR A REPEAT NON-CONTRAST CT OF THE CHEST AFTER POSTURING AND OXYGEN THERAPY. THE CUSTOMER HAD REPORTED THAT THE AIR HAD RESOLVED, THE PATIENT IS ASYMPTOMATIC AND IS DOING WELL.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6) , WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES USED DURING THE PROCEDURE; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. BAYER MEDICAL CARE RECEIVED INFORMATION FROM THE CUSTOMER STATING THAT IT IS UNKNOWN IF THERE IS A CORRELATION WITH PRIORLY REPORTED AIR INJECTIONS THAT OCCURRED ON (B)(6) 2025 (MFR REPORT NUMBER: 2520313-2025-00003, MFR REPORT NUMBER: 2520313-2025-00004). HOWEVER, BASED ON BAYER'S REVIEW OF ALL AVAILABLE INFORMATION, BAYER BELIEVES THAT OPERATOR ERROR WAS POTENTIALLY RESPONSIBLE FOR THIS INCIDENT. 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 APRIL 28, 2008 WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 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.

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS PERFORMED ON (B)(6) 2025, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLES THAT WERE IN USE DURING THE PROCEDURE WERE DISCARDED BY THE SITE; THEREFORE, THEY ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE LOT NUMBER OF THE DISPOSABLES USED DURING THE PROCEDURE; THEREFORE, TESTING OF RETAINED SAMPLES WAS NOT POSSIBLE. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING WAS DECLINED BY THE CUSTOMER. WE HAVE REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION. THIS INVESTIGATION IS ONGOING. 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 APRIL 28, 2008, WHICH WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF (B)(6) 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

BAYER MEDICAL CARE INC. WAS INFORMED THAT A 61-YEAR-OLD FEMALE UNDERGOING A CT PULMONARY ANGIOGRAM EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM ((B)(6)). FOLLOWING THE PROCEDURE, THE CUSTOMER REPORTED THAT AIR WAS VIEWED ON THE DISPLAYED IMAGES WITHIN THE PULMONARY ARTERY, RIGHT ATRIUM, RIGHT VENTRICLE, AND BRACHIOCEPHALIC VEIN. THE PATIENT WAS SENT FOR A REPEAT NON-CONTRAST CT OF THE CHEST AFTER POSTURING AND OXYGEN THERAPY. THE CUSTOMER HAD REPORTED THAT THE AIR HAD RESOLVED, THE PATIENT IS ASYMPTOMATIC AND IS DOING WELL.