DELIVERY SET

Additional Manufacturer Narrative

NO DEVICE-RELATED DEATH OR SERIOUS INJURY WAS REPORTED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PREP THE DEVICE AND CONTINUE THE CASE WITH NO COMPLICATIONS. THIS MDR IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION FOR THE POTENTIAL OF AIR EMBOLISM SHOULD THE EVENT RECUR. THE IFU STATES TO ENSURE NO AIR IS IN THE LINES. THE THIRD-PARTY PHARMACY HAS BEEN RETRAINED BY SIRTEX AND ADDITIONAL FOLLOW UP VISITS ARE PLANNED. SIRTEX MEDICAL AFFAIRS HAS REVIEWED THE CASE AND HAS STATED, BASED ON THE INFORMATION PROVIDED, THIS EVENT INVOLVED AIR NOTED IN THE DELIVERY SET LINES AFTER PREPARATION BY A THIRD-PARTY RADIOPHARMACY FOR A SPLIT-DOSE Y-90 CASE. THE PHYSICIAN IDENTIFIED THE ISSUE PRIOR TO ADMINISTRATION, WAS ABLE TO APPROPRIATELY PREP THE DELIVERY SET, AND PROCEEDED WITH THE CASE WITHOUT REPORTED PATIENT COMPLICATIONS. NO DEVICE-RELATED DEATH, SERIOUS INJURY, OR ADVERSE CLINICAL SEQUELAE WERE REPORTED. FROM A MEDICAL PERSPECTIVE, THIS APPEARS TO REPRESENT A POTENTIAL DEVICE/PROCEDURAL USE ISSUE RATHER THAN A CONFIRMED SIRTEX DEVICE FAILURE. HOWEVER, THE PRESENCE OF AIR IN THE DELIVERY LINES COULD POSE A CLINICALLY SIGNIFICANT RISK IF NOT DETECTED AND CORRECTED, INCLUDING POTENTIAL AIR EMBOLISM. THE IFU INSTRUCTS USERS TO ENSURE NO AIR IS PRESENT IN THE LINES; THEREFORE, CONTINUED RETRAINING/FOLLOW-UP WITH THE THIRD-PARTY PHARMACY IS APPROPRIATE. FILING THE MDR AS A MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION IS MEDICALLY REASONABLE.

Description of Event or Problem

ON (B)(6) 2026, THE PHYSICIAN STATED THE THIRD-PARTY RADIO PHARMACY LEFT AIR IN THE LINES WHEN PREPPING A SPLIT DOSE 4 WAYS FOR A TREATMENT PERFORMED (B)(6) 2026. THE PHYSICIAN STATED THEY WERE ABLE TO PREP THE DELIVERY SET AND CONTINUED WITH THE CASE WITH NO COMPLICATIONS.