EMPOWER CTA+

Description of Event or Problem

DURING A CT CHEST PULMONARY EMBOLISM (PE) PROTOCOL AND EVALUATION FOR PNEUMONIA, A 65-YEAR OLD PATIENT WAS INJECTED WITH 70 ML OF ISOVUE CONTRAST MEDIA AND 30 ML OF SALINE FLUSH AT A RATE OF 3.8 ML / SECOND. THE INJECTION SITE WAS THE PATIENT'S ANTECUBITAL FOSSA. DURING THE CONTRAST MEDIA INJECTION, THE PATIENT EXPERIENCED AN EXTRAVASATION OF CONTRAST MEDIA, AMOUNT UNSPECIFIED. THE CONTRAST MEDIA INJECTION WAS IMMEDIATELY STOPPED. THE MEDICAL PROFESSIONAL APPLIED A WARM COMPRESS TO THE LOCATION OF THE EXTRAVASATED CONTRAST. THERE WAS NO SERIOUS INJURY TO THE PATIENT AS A RESULT OF THE EXTRAVASATION. DURING REVIEW OF THE IMAGES, THE RADIOLOGIST NOTED A MODERATE AMOUNT OF INJECTED AIR WITHIN THE PATIENT'S RIGHT VENTRICLE AND MAIN/RIGHT PULMONARY ARTERIES. AS A PRECAUTION DUE TO THE VISUALIZED AIR NOTED IN THE PATIENT'S ARTERIES, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. ON (B)(6) 2026, BRACCO MEDICAL TECHNOLOGIES CONFIRMED THAT THE HOSPITALIZATION WAS REQUIRED FOR OBSERVATION OF THE PATIENT DUE TO THE AIR EMBOLISM. THERE WAS NO REPORT OF ADVERSE HEALTH EFFECTS SUBSEQUENT TO THE AIR INJECTION EVENT OR HOSPITALIZATION.

Additional Manufacturer Narrative

D4: LOT NUMBER - FASTLOAD CTA DUAL SYRINGE PACK, REF 017354, LOT NUMBER 287612. THE CTA+ INJECTION SYSTEM, SERIAL NUMBER (B)(6), WAS FUNCTIONALLY TESTED AND MET THE PRE-ESTABLISHED SPECIFICATIONS. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED, AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR USE OF THE DEVICE. BASED ON THE TESTING AND EVALUATION OF THE CTA+ INJECTION SYSTEM, THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION RELATED TO THE EVENT. PER EMPOWERCTA®+ INJECTOR SYSTEM USER'S GUIDE, "THE EMPOWERCTA®+ INJECTOR SYSTEM MUST BE USED PROPERLY TO PREVENT THE RISK OF AN AIR EMBOLISM. ALWAYS FILL THE SYRINGE WITH THE INJECTOR POINTING FULLY UPWARD. WHEN THE SYRINGE HAS BEEN FILLED TO THE DESIRED VOLUME, ALL THE AIR SHOULD BE PURGED FROM THE SYRINGE AND COILED TUBING WITH THE INJECTOR STILL IN THE FULLY VERTICAL POSITION. FAILURE TO DO SO MAY LEAD TO SERIOUS INJURY AND/OR DEATH." THE LOT NUMBER OF THE EMPOWER SYRINGE KIT USED DURING THE EVENT WAS PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORD WILL BE COMPLETED AND PROVIDED IN THE FOLLOW-UP REPORT. THE EMPOWER CONSUMABLE KITS WERE REQUESTED FOR EVALUATION BUT ARE NOT AVAILABLE AS THEY HAD BEEN DISCARDED BY THE USER FACILITY. BRACCO'S MEDICAL ADVISOR REVIEWED THE INFORMATION PROVIDED BY THE USER FACILITY AND THIS CLINICAL ASSESSMENT IS AS FOLLOWS: REGARDING THE AIR INJECTION, IT HAS BEEN WELL ESTABLISHED THAT VOLUMES OF AIR INJECTED INTRAVENOUSLY GREATER THAN 25 CC HAVE THE POTENTIAL FOR SERIOUS HARM, PERMANENT DISABILITY, OR DEATH WHEREAS VOLUMES LESS THAN 10 CC IN ADULTS ARE CONSIDERED ESSENTIALLY SAFE. MOST CASES OF INADVERTENTLY ADMINISTERED AIR ARE DUE TO IMPROPER PURGING OF AIR AND RESULT IN 1-10 CC OF AIR BEING ADMINISTERED, A VOLUME NOT CONSIDERED CAPABLE OF CAUSING SERIOUS PATIENT HARM. REGARDING THE EXTRAVASATION, THE OCCURRENCE OF AN EXTRAVASATION IS NOT UNUSUAL, AND WITH THE ADVENT OF NON-IONIC CONTRAST MEDIA, IS GENERALLY CONSIDERED A MINOR HARM. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.