IT WAS REPORTED THAT FOLLOWING A BRACHYTHERAPY PROCEDURE, ONE MICK CARTRIDGE WAS DETERMINED TO BE "HOT." WHEN TESTED, THE PATIENT'S URINE WAS FOUND TO BE "HOT." THERE HAD BEEN NO JAMMING OF THE MICK CARTRIDGE DURING THE PROCEDURE. IN 2006, THE PHYSICIST HAD FOUND ONE BENT SEED WHILE DOING HIS ASSAY. THE PHYSICIST PERFORMED A WIPE TEST ON THE SEED AND FOUND NO MEASURABLE REMOVABLE CONTAMINATION. THE SEED WAS NOT RELOADED, IT WAS ISOLATED IN A GLASS VIAL INSIDE A LEAD PIG. BOTH THE MICK CARTRIDGE AND THE SEED ARE BEING RETURNED FOR EVALUATION TO DETERMINE IF THE CONTAMINATION IS FROM ONE OF THE SEED OR FROM SOME OTHER RADIOACTIVE ISOTOPE IN THE PATIENT'S BLOOD FROM PREVIOUS NUCLEAR MEDICINE TEST. A URINE ANALYSIS WAS PERFORMED 2 DAYS LATER AND AGAIN 2 DAYS AFTER THAT, URINE WAS FIVE TIMES AS HOT. THE PHYSICIST RE-SURVEYED THE STAINLESS STEEL PIG THAT THE SEEDS WERE SHIPPED IN AND THERE WAS A SMALL AMOUNT OF RADIATION IN THE BOTTOM OF THE PIG. THYROID UPTAKE STUDIES WERE PERFORMED WITH THE RESULTS NOT YET AVAILABLE, AND THE PATIENT WAS PRESCRIBED THYROID BLOCKERS IN THAT DAY. THE MICK APPLICATOR WAS ALSO RE-SURVEYED; THERE WAS ACTIVITY OF 1500 CPM COMPARED TO BACKGROUND OF 500 IN THE RIGHTMOST HOLE OF THE LOADING BLOCK. SCRUB NURSE INDICATED SHE MOVED THE CARTRIDGES TO THE BLOCK AT THE START OF PROCEDURE AND DID NOT MIX UP THE CARTRIDGES. EVENT WAS REPORTED TO NCR & IEMA.
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Patient 1
THE BENT SEED, MICK MAGAZINE, AND MICK APPLICATOR WERE RETURNED FOR EVALUATION. THE SEED WAS BENT IN THE MIDDLE, BUT IS NOT CONTAMINATED. THE MICK MAGAZINE WAS SLIGHTLY CONTAMINATED. THE RETURNED MICK APPLICATOR WAS TESTED USING THE CUSTOMER'S RETURNED MICK MAGAZINE AND SEED SIMULATIONS. (15) SEED SIMULATIONS WERE EXPELLED (3) TIMES WITHOUT ANY ISSUES. THIS CORRELATES WITH THE CUSTOMER'S CLAIM THAT THERE WERE NO ISSUES WITH JAMMING DURING THE PROCEDURE. BASED ON WHAT WAS RETURNED AND WHAT INFORMATION IS AVAILABLE, THE SOURCE OF THE CONTAMINATION IS UNKNOWN TO US. THE RETURNED BENT SEEN WAS DEFINITELY NOT CONTAMINATED/ LEAKING. A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE SEEDS USED IN THE CUSTOMER ORDER MET ALL REQUIREMENTS FOR RELEASE, INCLUDING, SPECIFICALLY, DIAMETER GAUGING. THE ORDER PROCESSING RECORDS INDICATE THAT THE ORDER MET ALL REQUIREMENTS FOR RELEASE. DURING ORDER PROCESSING, EACH LOADED MAGAZINE WAS VISUALLY INSPECTED TO ENSURE ALL SEEDS WERE POSITIONED CORRECTLY IN THE CARTRIDGES. NO EVIDENCE EXISTS THAT WOULD INDICATE THIS EVENT WAS CAUSED BY NONCONFORMING IMPLANT SEEDS OR A MISLOADED MICK MAGAZINE.