Owner's manual

PRODUCT NAME
ReSolve® NL (Non-Locking) Drainage Catheter with
Hydrophilic Coating
DESCRIPTION OF THE PRODUCT
The ReSolve NL Drainage Catheter with hydrophilic coating
is a radiopaque catheter with multiple side holes used for
percutaneous drainage. The components of the catheter
allow for introduction and placement using a trocar
stylette or over-the-wire method. The ReSolve NL Drainage
Catheter may be packaged in a pouch with the following
components:
One (1) Resolve NL Drainage Catheter with
hydrophilic coating (A)
One (1) Metal stiening cannula (B)
One (1) Trocar stylette (C)
INDICATIONS FOR USE
The ReSolve NL Drainage Catheter with hydrophilic coating
is intended for percutaneous drainage of uid from body
cavities.
CONTRAINDICATIONS
The ReSolve NL Drainage Catheter is contraindicated
for use where percutaneous drainage catheterization is
unacceptable.
The ReSolve NL Drainage Catheter is contraindicated for
intravascular use.
RESTRICTED DEVICE
P
x
Only: Caution: Federal (U.S.A.) law restricts this device
to sale by or on the order of a physician trained and/or
experienced in the use of this device.
PRECAUTIONS
• Read manufacturer’s instructions prior to use.
• Contents are sterile (via ethylene oxide) and
non-pyrogenic.
• Do not use if packaging is opened, damaged or broken.
• For single patient 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.
• Follow universal precautions when inserting and
maintaining this device. Due to the risk of bloodborne
pathogens, healthcare professionals should always use
standard blood and body uid precautions in the care of
all patients. Sterile technique should always be followed.
• Do not use after expiration date.
• Store in a cool, dry place.
WARNING: The ReSolve NL Drainage Catheter is not to be
used to deliver nutritional supplements.
ADVERSE REACTIONS*
• Septic shock
• Bacteremia
• Hemorrhage
• Superinfection
• Bowel transgression
• Pleural transgression
• Vascular injury
• Pneumothorax
• Skin Infection
• Catheter Occlusion
• Catheter Dislodgement
*Brountzos EN. Quality improvement guidelines for percutaneous
nephrostomies.[Internet]. 2006. CIRSE.org. http://cirse.org/les/
File/05_qig.pdf. Accessed 04/11/13.
Wallace MJ, et al. Quality improvement guidelines for percutaneous
drainage/aspiration of abscess and uid collections. J Vasc Interv
Radiol. 2010;21:431-435.
Ramchandani P, et al. Quality improvement guidelines for percutane-
ous nephrostomy. J Vasc Interv Radiol. 2003;14:S277-S281.
INSTRUCTIONS FOR USE
PLACEMENT TECHNIQUES OPTION 1:
DIRECT PUNCTURE USING TROCAR STYLET
1. Remove the stiening cannula and trocar stylette assem-
bly from the ReSolve NL Drainage Catheter.
2. Ensure that the distal portion of the catheter is wet prior
to placement.
CAUTION: To maximize the advantages of the hydrophilic
coating on the surface of the distal portion of the catheter,
wet the catheter prior to use with sterile water or saline.
Keep catheter wet during placement.
WARNING: DO NOT wipe catheter with dry gauze or any
solvents because it may damage the catheter coating.
3. Flush catheter prior to use.
4. Place the metal stiening cannula into the catheter and
tighten the Luer lock ttings. See Figure 1.
Figure 1
5. Remove the paper spacer from the trocar stylette.
Advance the trocar stylette through the metal stiening
cannula and tighten the Luer lock ttings. See Figure 2.
Figure 2
6. Place the catheter/cannula/trocar assembly into the
uid collection site using standard insertion technique.
Placement should be conrmed with diagnostic imaging.
7. After placement is conrmed, remove the trocar stylette
and stiening cannula.
8. The ReSolve NL Drainage Catheter is now ready to be
connected to appropriate drainage bag or tubing.
9. A ush regimen should be designed for the circum-
INSTRUCTIONS FOR USE
English