Merit Medical ReSolve Instrucciones De Uso página 2

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.
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.
• 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.
English • 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.
WARNING: The ReSolve Locking Drainage Catheter is not to
be used to deliver nutritional supplements.
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 percutane-
ous nephrostomy. J Vasc Interv Radiol. 2003;14:S277-S281.
INSTRUCTIONS FOR USE OPTION 1:
DIRECT PLACEMENT USING TROCAR STYLET
1. 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.
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.
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 2
4. Remove pigtail straightener from catheter prior to
insertion.
5. Place the catheter/cannula/trocar assembly into the fluid
collection site using standard insertion technique.
Note: Placement should be confirmed with diagnostic
imaging.
6. After placement is confirmed, remove the trocar stylette
and stiffening cannula.
7. To engage the suture locking mechanism: Pull the suture
until desired pigtail is formed. Rotate the suture locking
mechanism distally to hold the suture in place. See Figure 3.