[182551760]
One icepearl cx cryoablation needle was used for a left renal lesion (1. 2cm mass). An additional icesphere cx needle was introduced in the third freeze cycle of the procedure. Both needles passed testing, with no leaks, a uniform iceball, with correct formation followed by proper thawing. No error message occured during the needle test. A biopsy was performed prior to freezing, and the needle positioning was confirmed with ct with no critical structures were observed near the planned ablation zone. The iceball was not visible throughout the procedure. No fluctuation in needle temperature, freezing percentage and gas pressure was observed throughout the entire procedure. Contrast was produced in the fourth cycle, but no iceball was visible. The user specifically noted that ice was not visible at the following timepoints: first freeze - 5 minutes, first freeze - 8 minutes, second freeze, third freeze, fourth freeze. After the procedure, the needles were then tested by being submerged in basin of water, and tested successfully with ice immediately forming. There was no indication of a freezing error, needle leak or needle clog. The needles were kept and will be returned to the manufacturer for investigation. At the post scan of the procedure, no enhancement or bleeding was observed. The user decided to wait at the follow-up scan to determine if the ablation was successful. The patient has not experienced any complications. This report is being filed conservatively on the premise that the treatment may not have been successful, and a new treatment may have to be planned for this case. This mdr is for the icesphere cx needle that was used during the case. Please refer to mdr # 9616793-2020-00049 for the icepearl cx needle used during this procedure.
Patient Sequence No: 1, Text Type: D, B5