Warning; Safety; Warnings; Precautions - Boston Scientific REZUM Mode D'emploi

rezūm
™
Delivery Device Kit for BPH
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNING

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile
barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead
to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative
and/or local government policy.

SAFETY

This section contains important safety information. Boston Scientific requires that you
read and understand all warnings, cautions, precautions and the operator's manual
prior to using the Rezūm System.

WARNINGS

Training: Boston Scientific requires physician training specific to the Rezūm System
procedure prior to use. Please contact Boston Scientific for more information.
Familiarity with Cystoscopic Procedures: Users should be familiar with cystoscopic
procedures and techniques for treating benign prostatic hyperplasia before using the
Rezūm System.
Use Under Prescription: Federal Law restricts this device to sale and use by or on the
order of a physician (or properly licensed practitioner).
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.
Sterility/Damaged Packaging: Do not use the Delivery Device and its contents if the
packaging's sterile barrier is broken, the seal is damaged, or the device is damaged.
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.
Service or Maintenance While in Use in Patient: No modification of this equipment is
allowed. Do not attempt to service or maintain the Generator while in use with a patient.
Urethral Strictures: Urethral strictures should be ruled out as a cause of obstruction
prior to treatment with Rezūm.

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.
Single-Use Only Device: The Delivery Device is intended for single-use only. Do not
reuse, reprocess or resterilize the device. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/or create a risk of contamination
of the device, which could result in patient injury or illness.
Exterior Surface of Sterile Water Vial: The exterior of the Sterile Water Vial is not sterile
and should not be placed in the sterile field.
Positioning Saline Flush Line in Saline Pump: Reference indicators on Generator to
ensure Saline Flush Line is positioned in the correct direction. If Saline Flush Line is placed
in a backwards direction within the Saline Pump, saline will not flow during procedure.
Remaining Saline Level in Bag: Care should be taken during procedure to monitor
remaining saline level in bag. If saline bag is empty, patient could experience urethral
discomfort due to no flush flow.
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.
Overfilling of Bladder: Care should be taken during procedure to monitor the amount of
saline instilled. If bladder is not empty, overfilling of bladder may occur. The Generator
helps monitor the amount of saline instilled.
Continued or Worsening of LUTS: During healing phase, patient may experience a
continued or worsening of LUTS, which may require the use of a catheter for several
days. Cystoscopic intervention during the healing phase may also lead to continued or
worsening of LUTS. For more information on these types of events in the clinical study,
please refer to the Clinical Summary section of the DFU.
Room Temperature Saline: Saline should be at room temperature. Do not use cold saline,
which may reduce the effectiveness of the therapy.
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.
Priming Cycle: If finger is released from Vapor Activation Button before the priming cycle
is complete, vapor will automatically stop and the priming steps will have to be repeated.
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.
Excessive Treatments: Treatments in excess of those recommended in the guidelines
may lead to prolonged irritative symptoms and/or catheterization.
Disposal Instructions: After use, this product should be treated as a potential
biohazard. Handle and dispose of in accordance with acceptable medical practices
and applicable local, state and federal guidelines.

INDICATIONS FOR USE

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate
tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a
prostate volume ≥ 30 cm . The Rezūm System is also indicated for treatment of prostate
3
with hyperplasia of the central zone and/or a median lobe.

CONTRAINDICATIONS

The use of the Rezūm System is contraindicated for the following:
• Patients with a urinary sphincter implant
• Patients who have a penile prosthesis
• Patients who have an active urinary tract infection
THE REZŪM SYSTEM OVERVIEW
The Rezūm System is designed to treat patients with bothersome urinary symptoms
associated with BPH. The Rezūm System utilizes radiofrequency current to generate "wet"
thermal energy in the form of water vapor, which is then injected into the transition zone
and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is
injected into the prostate tissue rapidly disperses through the interstitial space between the
tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the
stored thermal energy is released, denaturing the cell membranes and causing cell death.
The denatured cells are absorbed by the body, which reduces the volume of prostate tissue
adjacent to the urethra. The vapor condensation process also causes a rapid collapse of
vasculature in the treatment zone, resulting in a bloodless procedure. Following thermal
therapy for BPH, small pieces of treated tissue may slough off and be expelled via urination.
This sloughing process may continue for a few months post-procedure depending on the
rate of healing.
3
Black (K) ∆E ≤5.0