Boston Scientific rezum, Directions For Use Manual

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2
Boston S
cientific (Master Brand DFU
Template 8.5in x 1
1in Global, 9223851
5B), DFU
, MB, R
ezum, Global, 50966794-0
1A
Black (K) ∆E ≤5.0 Black (K) ∆E ≤5.0
rez ū m
™
TABLE OF CONTENTS
WARNING ......................................................................................................................................3
SAFETY ...........................................................................................................................................3
WARNINGS ....................................................................................................................................3
PRECAUTIONS...............................................................................................................................3
INDICATIONS FOR USE ................................................................................................................3
CONTRAINDICATIONS .................................................................................................................3
THE REZ
Ū
M™ SYSTEM OVERVIEW ..........................................................................................3
CONTENTS .....................................................................................................................................4
REZ
Ū
M GENERATOR ....................................................................................................................4
Figure 1. Rez
ū
m Generator. ............................................................................................... 4
REZ
Ū
M DELIVERY DEVICE KIT ...................................................................................................4
Figure 2. Delivery Device Components. .......................................................................... 4
Table 1. Functional Description of the Delivery Device ................................................ 4
THE REZ
Ū
M PROCEDURE ............................................................................................................4
User Supplied Materials ......................................................................................................... 4
Preparing the Patient ............................................................................................................. 4
Power Up the Rez
ū
m Generator ........................................................................................... 4
Figure 3. Power up the Rez
ū
m Generator. ...................................................................... 5
Prepare the Sterile Saline Bag .............................................................................................. 5
Figure 4. Hang the saline bag on IV pole. .......................................................................
5
Unpack Contents of Delivery Device Kit .............................................................................. 5
Prepare the Syringe ................................................................................................................
5
Figure 5. Filling the syringe. .............................................................................................. 5
Set Up the Rez
ū
m Delivery Device ....................................................................................... 5
Figure 6. Connecting cable into Generator. ................................................................... 5
Figure 7. Loading Saline Flush Line into Saline Pump. ................................................ 5
Figure 8. Connecting Saline Flush Line to Saline Bag. ................................................ 6
Figure 9. Loading Syringe. ................................................................................................ 6
Figure 10. Closing clamp on Drain Line. .........................................................................
6
Insert the Rigid Cystoscope Lens .......................................................................................... 6
Figure 11. Insert Rigid Cystoscope Lens. .......................................................................
6
Priming the Delivery Device ................................................................................................... 6
Figure 12. Steps for Activating Vapor Treatment. ......................................................... 6
Perform the Pre-Treatment Vapor Cycle .............................................................................. 6
Perform the Rez
ū
m Vapor Treatment ................................................................................... 7
Figure 13. Prostatic Treatment Length. .......................................................................... 7
Table 2. Guidelines for determining the number of treatments (lateral lobe). .......... 7
Figure 14. Illustrative example of 6 Vapor Treatments. ................................................
7
Post Procedure ........................................................................................................................ 8
METHOD FOR DRAINING THE BLADDER .................................................................................8
METHOD FOR CLEARING VISUAL FIELD AND/OR REMOVING A CLOT ...............................8
METHOD FOR MANUAL NEEDLE RETRACTION ......................................................................8
Figure 15. Pulling Down Release Pin. ............................................................................. 8
Figure 16. Holding Shaft Steady in Patient, Withdraw the Handle
Just Sufficiently to Draw the Needle into the Shaft Tip (1 inch minimum). ............... 8
Figure 17. Holding Shaft Steady in Patient, Pull Needle Driver
Out of Shaft to Retract Needle Into Tip. .......................................................................... 8
STORAGE, HANDLING, AND DISPOSAL ...................................................................................9
Rigid Cystoscope Lens ............................................................................................................ 9
Rez
ū
m Delivery Device ........................................................................................................... 9
Rez
ū
m Generator ..................................................................................................................... 9
Disposal of the Product, Accessories and Packing Materials ........................................ 9
PIVOTAL CLINICAL STUDY SUMMARY ....................................................................................9
Efficacy ...................................................................................................................................... 9
Graph 1. Mean IPSS Over Time. ...................................................................................... 9
Graph 2. Mean Qmax Over Time. ..................................................................................... 9
Graph 3. Mean QoL Over Time. ........................................................................................ 9
REPORTED ADVERSE EVENTS ...................................................................................................9
Table 3. All Adjudicated Procedure and/or Device Related AEs for Treatment and
Crossover Subjects Through 4 Year Follow-up. ........................................................... 10
Other Potential Adverse Events .......................................................................................... 10
Pain Management .................................................................................................................
10
Table 4. Types of Medication Used. ............................................................................... 10
Catheterization .......................................................................................................................
10
Table 5. Catheterization. .................................................................................................. 10
Subsequent Treatments ........................................................................................................ 10
Graph 4. Subsequent Retreatments (Cumulative). ...................................................... 10
Supplier’s Declaration of Conformity
47 CFR § 2.1077 Compliance Information ...................................................................... 10
WARRANTY .................................................................................................................................11