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Locking Drainage Catheter
I N S T R U C T I O N S F O R U S E
PRODUCT NAME
ReSolve® Locking Drainage Catheter
DESCRIPTION OF THE PRODUCT
The ReSolve Locking Drainage Catheter with locking pigtail
and 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 Locking Drainage Catheter may be packaged
with the following components:
• One (1) ReSolve Locking Drainage Catheter with locking
pigtail (A), hydrophilic coating and pigtail straightener (B)
• One (1) Metal stiffening cannula (C)
• One (1) Flexible stiffening cannula (D)
• One (1) Trocar stylette (E)
• One (1) Repositioning Tool (F)
• One (1) Dead end cap (G)
• One (1) Marker band (H)
INDICATIONS FOR USE
The ReSolve Locking Drainage Catheter with locking pigtail
and hydrophilic coating is intended for percutaneous
drainage of fluid from body cavities
CONTRAINDICATIONS
The ReSolve Locking Drainage Catheter is contraindicated
for use where percutaneous drainage catheterization is
unacceptable.
The ReSolve Locking Drainage Catheter is contraindicated
for intravascular use.
INTENDED USER
The ReSolve Locking Drainage Catheter is intended for use
by trained healthcare professionals.
PRECAUTIONS
• Read manufacturer's instructions prior to use.
• Contents of unopened, undamaged package are sterile.
• 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
English
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 fluid 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.
WARNINGS
• The ReSolve Locking Drainage Catheter is not to be used
to deliver nutritional supplements.
• The ReSolve Locking Drainage Catheter is not to be used
in the biliary system.
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.
ADVERSE REACTIONS*
• Septic shock
• Bacteremia
• Hemorrhage
• Superinfection
• Bowel transgression
• Pleural transgression
• Vascular injury
• Catheter dislodgement
• Catheter occlusion
*Brountzos EN. Quality improvement guidelines for percutaneous
nephrostomies. [Internet]. 2006. CIRSE.org.
http://cirse.org/files/File/05_qig.pdf. Accessed 04/11/13.
Wallace MJ, et al. Quality improvement guidelines for percutaneous
drainage/aspiration of abscess and fluid collections. J Vasc Interv
Radiol. 2010;21:431-435.
Ramchandani P, et al. Quality improvement guidelines for
percutaneous nephrostomy. J Vasc Interv Radiol. 2003;14:S277-S281.
INSTRUCTIONS FOR USE OPTION 1:
DIRECT PLACEMENT USING TROCAR STYLET
1. Ensure that the distal portion of the catheter is wet prior
to placement. To activate the hydrophilic coating, wet the
distal portion of the ReSolve Locking Drainage catheter
prior to use with sterile water or saline. Keep the distal
portion of the catheter wet during placement. Activating
the hydrophilic coating will make the catheter slippery to
help with catheter placement.
WARNING: DO NOT wipe catheter with dry gauze or any
solvents because it may damage the catheter coating.
2. Slide pigtail straightener along distal portion of catheter
to straighten curve prior to placing metal stiffening
cannula into the catheter. Place the metal stiffening
cannula into the catheter and tighten the Luer lock
fittings. See Figure 1.
3. Remove the paper spacer from the trocar stylette.
Advance the trocar stylette through the metal stiffening
cannula and tighten the Luer lock fittings. See Figure 2.
Figure 1
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