Rezūm™ Water Vapour Therapy

Delivery Device Kit Warnings:

• Tissue Healing After Biopsy or Prior Prostate Surgery: After biopsy or prior prostate surgery, allow tissue to heal (e.g. 30 days) prior to performing Rezūm System procedure. 
• Priming Cycle: Point the Delivery Device tip away from patient or personnel during the priming cycle. Vapor coming out of the tip is hot and can burn the skin. 
• Flush Button Pressure: Excessive pressure while using Flush Activation Button may cause unintended deployment of the needle.  
• Needle Placement: Proper placement of the needle is essential. Do not direct the needle downward toward the rectum. 
• Location of Verumontanum: Prior to each treatment, know where the verumontanum is in relation to the tip of the shaft. All treatments should be placed proximal to the verumontanum.  
• Needle Tip: Do not start treatment if the black depth marker on the needle is still visible after needle deployment. If the marker is still visible, push the needle deeper into the prostate until no black is visible through the lens. If unable to position correctly, deliver vapor for ~4 seconds to devascularize the site, then retract needle by pressing upward on the Needle Retraction Button. Reposition Delivery Device approximately 1 cm from the partially treated site and repeat needle deployment steps. 
• Needle Retraction: Prior to starting procedure, the needle should be fully retracted. During procedure, ensure needle is fully retracted by viewing needle position through scope lens. If needle is not retracted prior to repositioning Delivery Device, damage to urethra may occur. 
• Manual Needle Retraction: Do not remove device from the patient if the needle is not fully retracted. In case of incomplete needle retraction, manually retract the needle before removing the device from the patient. For instructions on how to manually retract the needle, see Method for Manual Needle Retraction section. Do not attempt to reassemble device for reuse after manual needle retraction. 
• Sterile Water: Do not fill the syringe with any liquid other than the grade of water specified in the User Supplied Materials section. 
• Turbo Flush: Use caution when activating Turbo Flush. Not doing so can cause the needle to deploy inadvertently.  
• Sterile Water Usage: Do not use the sterile water for another application other than the Rezum System (e.g., intravenous administration). Doing so can cause patient injury and/or hemolysis. 

Generator/EVO Precautions:

• When any of the following occur, turn the power OFF, remove all accessories from the patient, and unplug the power cord from the outlet. 
  ° There is smoke or a strange odor leaking out of the generator. 
  ° The generator has been dropped or impacted by an object.
  ° Liquid or foreign matter gets inside the generator.
  ° Damage to the generator is suspected.  
  

• Use caution when handling the Delivery Device when connected to the Console as the Delivery Device is now energized. Not doing so can cause inadvertent needle deployment and user injury. 
• After four hours of delivery device initialization with the Rezūm EVO Console, the delivery device will no longer be able to be re-initialized with the Rezūm EVO Console, requiring delivery device replacement. 
• The system will attempt to retract the needle automatically during setup.If unsuccessful, the system will prompt the user to manually retract the needle. If needle remains deployed, replace the delivery device; not doing so can cause user injury. 
• Ensure needle is retracted after pre-treatment. Not doing so can cause user injury. 
• The Rezūm EVO Console will output an error message after 200 seconds of steam generation, 15 full treatments, or 20 needle deployments, requiring delivery device replacement. 
   

Delivery Device Precautions: 

• Prior Radiation: There is no data on the use of this treatment in patients who have undergone prior radiation therapy in the pelvic region.
• Movement of Delivery Device: Once needle is deployed, hold the Delivery Device steady. Movement of the Delivery Device may stretch tissue and cause vapor to leak into the urethra, possibly causing urethral irritation. Extreme movement may also cause pressure on the needle resulting in difficulty with needle retraction. Needle must be returned to the original insertion position to facilitate retraction.
• Scope Lens: The Delivery Device is compatible with a 4 mm, 30-degree, 30 cm Storz™, InnoView™ or Richard-Wolf™ cystoscopic lens. Use of other scope lenses may impact performance of the Delivery Device.  
• Vapor Activation: Do not release Vapor Activation button during vapor treatment cycle. If Vapor Activation Button is released before treatment cycle is complete, vapor release will automatically stop, which may lead to partial and incomplete treatment.  
• Air Bubbles in Syringe: Ensure air bubbles are removed from the syringe. If bubbles are trapped in the line, an insufficient treatment may result. 

• Dysuria 
• Hematuria
  ° Gross
  ° Gross with clots
  ° Intermittent uncomplicated
  ° Gross with retention
  ° Micro 
• Hematospermia 
• Urinary Frequency 
• Urinary Retention 
• Urinary Tract Infection (UTI)
  ° Suspected
  ° Culture Proven
  ° Prophylaxis
• Decrease in Ejaculatory Volume 
• Urinary Urgency 
• Anejaculation 
• Terminal Dribbling 
• Epididymitis 
• Erectile Dysfunction, Worsening 
•  Pain 
  ° Discomfort with Ejaculation
  ° Discomfort, Pelvic
  ° Discomfort, Penile
  ° Discomfort with Right Testicle
  ° Discomfort, Abdominal
  ° Discomfort, Leg
  ° Discomfort, Other
  ° Discomfort, Perineum 
• Prostatitis 
• Urethral Stricture 
• Incomplete Voiding 
• Poor Stream 
• Splayed Stream 
• Urinary Incontinence, Urge 
• Anxiety 
• Catheter Malfunction 
• Delay in Healing 
• Fever 
• Hesitancy
• Irritative Voiding Symptoms 
• Nausea 
• Perforation, Prostate 
• Prostatic Calculi 
• Retrograde Ejaculation, Confirmed 
• Sepsis 
• Urethral Injury 
• Urinary Incontinence, Mixed 
• Urinary Incontinence, Stress 
• Vomiting 

Other Potential Adverse Events
The following adverse events were not reported in the Rezūm™ II pivotal study: de novo erectile dysfunction, pelvic abscess, rectal wall injury, fistula, hemolysis, infection, inflammation, obstruction, prostate capsule perforation and syncope. Delivering a form of thermal therapy or misuse of the device has the potential for producing these adverse effects.