The State of
Wisconsin submitted the following information via email:
On September 27, 2012 the Wisconsin Radiation Protection Section received a notification that Pd-103 Theraseed model 200 seed cartridges from Theragenics failed to function as designed while preparing for a prostate seed implant procedure.
The procedure was scheduled and pre-planned as a 'linked' procedure, with 145 Pd-103 seeds ordered from Theragenics. The order was received timely and the seed calibration was verified. Upon arriving in the Operating Room, the pre-implant testing routinely performed on the linker device worked appropriately, the procedure is performed with blank seed and spacer cartridges. The intraoperative pre-plan was performed from the ultrasound images as normal.
While attempting to make the linked seeds + spacers the licensee ran into immediate jams. They initially thought it was the link making device, retrieved a spare and encountered the same issue. Shortly after they discovered the seed cartridges had a flaw, the hole on the entrance side of the cartridge was not completely open, thus the link wire could not enter the cartridge to push a seed through. A second cartridge was found with the same problem. On a third cartridge they were able to make a linked needle but the operation was not smooth.
The Authorized User then decided to change the implant to a MICK applicator technique. All seeds were transferred to sterilized MICK cartridges. The implant proceeded with the MICK applicator. Upon completion of the implant it appears to be a satisfactory implant.
DHS [Wisconsin Department of Health Services] plans to investigate on Wednesday, October 3, 2012 when a Theragenics representative is present.
Event Report ID No.: WI20014