[889308]
Image guided placement of a partial breast radiation brachy catheter device was planned. The cavity was measured at 5. 87cm x 2. 32cm and was somewhat irregularly shaped, but the seroma cavity was well visualized. A laparoscopic trocar device was used to dilate the tract and a savi 8. 1 breast applicator device was inserted under direct vision. When the struts were deployed there was quite a bit of resistance met. The catheter was removed and inspected. The catheter had deformed from the scar tissue within the cavity since the cavity was approximately 8 weeks old at the time. A balloon applicator was filled with 30ml of sterile saline and used to dilate the seroma cavity. The catheter was allowed to dwell in the seroma for several minutes and the saline was evacuated. A fresh savi 8. 1 device was then applied. The new catheter was applied under us guidance into the seroma cavity. It went in easily and seemed to deploy well. The applicator was turned four complete revolutions to partially deploy the device. Placement was verified using us in a transverse orientation and the struts were partially deployed as expected. The following day the patient was called back for additional ct simulations with treatment planning. Based on the ct imaging, the catheter was expanded when it was determined that it was not fully expanded originally. No problems were reported with that expansion. However, they did see that multiple struts were inverted which required a recommendation to remove the device. The doctor attempted to take the struts down but the catheter was completely jammed and the apparatus was not functioning properly. The savi physicist was present and witnessed that the device did not deflate properly. The doctor did remove the device at that time when it was determined that it would slide out, rather than take the patient to surgery. The patient was medicated with morphine and the area was closed with steri-strips. A small area of ecchymosis developed at the site but there was no sign of infection. This event was reviewed by radiation physicists at this facility who stated: it is possible that the time period between the lumpectomy and the catheter implant may have exceeded the recommended time limit. It was noted that identification of the catheters on ct was difficult because some were inverted. The catheter inversions may have been caused by the fibrotic cavity. The cavity was contoured on pinnacle and the estimated volume was 91. 5 cc which exceeds the recommended limit (90. 0cc)of the largest (10-1) savi implant and this was communicated to the manufacturer. The manufacturer told the medical providers at our facility that, among other things, the cavity may shrink so this was not a concern. It had been 8 weeks since the lumpectomy was performed, at the time the catheter was placed, which exceeded the 6 week recommended limit. Two manufacturer's reps were present and assisted during the implant. The day after the implant the patient was scanned and the images were transferred first to pinnacle and then to brachyvision for planning. A physician from cianna was present to assist. This was our facility's first savi case. Ct images showed the inverted catheter struts, probably caused by the length of time between surgery and insertion of the catheter. Attempts were made to make sure the device was fully expanded and a rep from cianna was present to help with that. Rescanning showed that the struts were clustered and could not be individually identified. Another rep from cianna informed the providers that the case could not be planned and the catheter was to be removed. The expansion tool was rotated by the doctor to collapse the implant and external inspection and lack of resistance gave the appearance that it had collapsed. The implant was pulled out, but following inspection after removal, it was clear that it had not collapsed. The catheter was given to the manufacturer's rep. No packaging was kept by the hospital, and no identifying information was recorded.
Patient Sequence No: 1, Text Type: D, B5