3033-001 Revision D January 2018
©NxThera 2018
Page 16 of 90
1.5.2
Potential Adverse Events
The following adverse events have not been reported in the clinical trials: erectile dysfunction,
pelvic abscess, rectal wall injury, and fistula. Delivering a form of thermal therapy or misuse of
the device has potential for producing these adverse effects.
1.5.3
Reported Adverse Events
The types of device related, or procedure related adverse events reported are typical of thermal
BPH ablation procedures. There were no clinically significant complications resulting from the
treatment.
A summary of the adverse events observed in NxThera clinical studies is presented in the Rezūm
Delivery Device Kit Instructions for Use for the Rezūm Delivery Device Kit, 3032-0XX.