MEDRAD® STELLANT CT INJECTION SYSTEM

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS COMPLETED ON (B)(6) 2026, WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS WITH NO EVIDENCE OF MALFUNCTION. ALTHOUGH THE DISPOSABLES WERE NOT AVAILABLE FOR EVALUATION, THE CUSTOMER REPORTED USE OF A MEDRAD® STELLANT SDS-CTP-SCS DISPOSABLE SYRINGE KIT. DUE TO UNCERTAINTY REGARDING THE LOT NUMBER, THREE POTENTIAL LOTS (8687102, 8685224, 8687903) WERE ASSESSED USING RETAINED SAMPLES. NO VISUAL OR FUNCTIONAL DEFECTS WERE IDENTIFIED, CONFIRMING THAT THE DISPOSABLE COMPONENTS PERFORMED TO SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE INJECTOR SYSTEM WAS MANUFACTURED IN ACCORDANCE WITH ESTABLISHED SPECIFICATIONS, WITH NO IDENTIFIED DEVIATIONS, NONCONFORMANCES, FAILURES, OR QUALITY-RELATED ISSUES. THE CUSTOMER DID NOT RESPOND TO BAYER'S OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLISM HAZARD - SERIOUS PATIENT INJURY OR DEATH MAY RESULT. EXPEL ALL TRAPPED AIR FROM THE SYRINGE(S), CONNECTORS, TUBING, AND CATHETER BEFORE CONNECTING THE SYSTEM TO THE PATIENT. CAREFULLY READ THE INSTRUCTIONS FOR LOADING AND THE USE OF THE MEDRAD® FLUIDOTS (WHERE APPLICABLE) TO REDUCE THE CHANCE OF AIR EMBOLISM. THE PRESENCE OF ROUNDED FLUIDOTS DOES NOT INDICATE THE TOTAL ABSENCE OF AIR BUBBLES IN THE SYRINGE TIP. FLUIDOTS MUST BE VIEWED IN A PROPERLY ILLUMINATED ENVIRONMENT WITH A LIGHT SOURCE BEHIND THE OPERATOR PROVIDING ENOUGH LIGHT TO PERMIT EASY VIEWING. ·BEFORE CONNECTING THE TUBING TO THE PATIENT, VISUALLY INSPECT THE SYRINGE AND TUBING TO CONFIRM THAT ALL AIR IS PURGED. TO MINIMIZE AIR EMBOLIZATION RISKS, ENSURE THAT ONE OPERATOR IS DESIGNATED RESPONSIBILITY FOR 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. TO MINIMIZE THE POSSIBILITY OF INADVERTENT ASPIRATION AND INJECTION, ENSURE THE PATIENT IS DISCONNECTED FROM THE INJECTOR WHEN UTILIZING THE FORWARD AND REVERSE PISTON CONTROLS. 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 (MARCH 26, 2007) WAS PRIOR TO THE UDI IMPLEMENTATION DATE OF SEPTEMBER 24, 2016 FOR CLASS II DEVICES. AS SUCH, THIS EQUIPMENT WAS NOT REQUIRED TO BEAR UDI MARKING AND/OR REPORTED INTO THE GUDID DATABASE AT THE TIME OF MANUFACTURE.

Description of Event or Problem

BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION AND SUBSEQUENT PATIENT DEATH THAT OCCURRED WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). A 58-YEAR-OLD MALE PATIENT UNDERWENT AN ENHANCED CT SCAN AS A FOLLOW-UP STATUS POST A PERIANAL FISTULA ABSCESS DRAINAGE AND SETON (A THIN, STRING-LIKE OR RUBBER MATERIAL INSERTED THROUGH A FISTULA TRACT) PLACEMENT. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF ALCOHOL (ETOH) AND TOBACCO ABUSE IN ADDITION TO SUBSTANCE USE DISORDER. FOLLOWING ADMINISTRATION OF IV CONTRAST AND OBTAINING IMAGES, THE PATIENT EXPERIENCED WHAT WAS THOUGHT TO BE A CONTRAST REACTION, FOLLOWED BY SUDDEN CARDIOVASCULAR COLLAPSE. UPON REVIEW OF THE DISPLAYED IMAGES, THE CUSTOMER REPORTED THAT APPROXIMATELY 60-70ML OF AIR WAS VISUALIZED. THE PATIENT WAS EMERGENTLY CODED AND RESUSCITATED 3 TIMES PRIOR TO BEING TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AFTER WHICH IT WAS REPORTED THAT THE PATIENT CEASED TO BREATHE. WE HAVE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, INCLUDING AN AUTOPSY STATEMENT. HOWEVER, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO BAYER MEDICAL CARE AT THIS TIME.