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 stiening cannula (C)
One (1) Flexible stiening 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 uid from body cavities
CONTRAINDICATIONS
The ReSolve Locking Drainage Catheter is contraindicated for use where percu-
taneous 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
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 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.
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.
ADVERSE REACTIONS*
• Septic shock
• Bacteremia
• Hemorrhage
• Superinfection
• Bowel transgression
• Pleural transgression
• Vascular injury
• Catheter dislodgement
• Catheter occlusion
*Brountzos EN. Quality improvement guidelines for percutaneous nephrosto-
mies.[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 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 stiening cannula into the catheter. Place the metal
stiening cannula into the catheter and tighten the Luer lock ttings. See Figure
1.
Figure 1
3. Remove the paper spacer from the trocar stylette. Advance the trocar stylette
through the metal stiening cannula and tighten the Luer lock ttings. See
Figure 2.
Figure 2
4. Remove pigtail straightener from catheter prior to
insertion.
5. Place the catheter/cannula/trocar assembly into the uid collection site using
standard insertion technique.
Note: Placement should be conrmed with diagnostic imaging.
6. After placement is conrmed, remove the trocar stylette and stiening
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.
Figure 3
Note: If the catheter needs to be repositioned, unlock the suture locking mecha-
nism by rotating the arm proximally to the point of resistance.
Precaution: Do not rotate the suture locking mechanism beyond the point of re-
sistance. Rotating the suture locking mechanism beyond the point of resistance
will not release the suture to allow the pigtail to straighten upon removal.
8. Once placement is conrmed, and the suture locking mechanism has been
rotated to the most distal position, press the suture locking mechanism into the
hub to secure it. The suture locking mechanism is now locked into position. See
Figure 4.
Figure 4
9. The ReSolve Locking Drainage Catheter is now ready to be connected to
appropriate drainage bag, tubing or dead end cap.
WARNING: If using alcohol to clean the catheter hub, allow sucient time for
alcohol to dry before connecting the drainage tubing or dead end cap.
WARNING: DO NOT over tighten the connection between the drainage catheter
and drainage tubing or dead end cap.
Note: A ush regimen should be designed for the circumstances of each patient
and the protocol of the physician.
Note: Instruct patient or other healthcare personnel in appropriate device
function and/ or maintenance.
INSTRUCTIONS FOR USE OPTION 2:
SELDINGER ENTRY TECHNIQUE OR GUIDE WIRE EXCHANGE
1. Remove the stiening cannula and trocar stylette assembly from catheter.
2. 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.
3. Slide pigtail straightener along distal portion of catheter to straighten curve
prior to placing the stiening cannula into the catheter. Place the stiening
cannula into the catheter and tighten the luer lock ttings. See Figure 5.
Figure 5
4. Remove pigtail straightener from catheter prior to insertion.
5. Place catheter/cannula assembly over appropriate guide wire and advance
into the uid collection site. The catheter accommodates a 0.038” (0.97 mm)
wire. See Figure 6.
Note: Placement should be conrmed with diagnostic imaging.
Figure 6
6. After placement is conrmed, remove the stiening cannula and guide wire.
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 7.
Figure 7
Note: If the catheter needs to be repositioned, unlock the suture locking mecha-
nism by rotating the arm proximally to the point of resistance.
Precaution: Do not rotate the suture locking mechanism beyond the point of re-
sistance. Rotating the suture locking mechanism beyond the point of resistance
will not release the suture to allow the pigtail to straighten upon removal.
8. Once placement is conrmed, and the suture locking mechanism has been
rotated to the most distal position, press the suture locking mechanism into the
hub to secure it. The suture locking mechanism is now locked into
position. See Figure 8.
Figure 8
9. The ReSolve Locking Drainage Catheter is now ready to be connected to
appropriate drainage bag, tubing or dead end cap.
WARNING: If using alcohol to clean the catheter hub, allow sucient time for
alcohol to dry before connecting the drainage tubing or dead end cap.
WARNING: DO NOT over tighten the connection between the drainage catheter
and drainage tubing or dead end cap.
Note: A ush regimen should be designed for the circumstances of each patient
and the protocol of the physician.
Note: Instruct patient or other healthcare personnel in appropriate device
function and/ or maintenance.
CATHETER EXCHANGE, REPOSITIONING OR REMOVAL
1. Disconnect catheter from drainage bag, tubing or dead end cap.
2. To release the pigtail loop choose one of the following options:
Option 1:
• Using the Repositioning Tool align the opening of the
round section of the Repositioning Tool in line with the
handle of the suture locking mechanism.
• Bring the at back of the Repositioning Tool around the
catheter hub.
• Gently squeeze together.
• Remove the Repositioning Tool and rotate the suture
locking mechanism to the most proximal position.
Precaution: Do not rotate the suture locking mechanism beyond the point of re-
sistance. Rotating the suture locking mechanism beyond the point of resistance
will not release the suture to allow the pigtail to straighten upon removal.
Option 2: For exchange or removal only, cut the hub o the drainage catheter
near the hub and sever suture. This will release the suture and the pigtail loop.
The hydrophilic coating may still be active making the distal portion of the
catheter slippery. Ensure the external portion of the catheter is secured during
and after cutting the hub to prevent the catheter from completely entering the
patient.
WARNING: The suture will no longer be secured to the catheter. Take care to
remove both the suture and catheter.
3. For catheter exchange or if access is to be maintained, advance appropriate
guide wire through catheter; using diagnostic imaging to conrm guide wire
placement. Guide wire will maintain access to drainage site. To ease guide wire
placement, a stiening cannula may be used.
WARNING: When long-term use is indicated, it is recommended that indwelling
time not exceed 90 days. The ReSolve Locking Drainage Catheter should be
evaluated by a physician on or before 90 days post placement.
4. Carefully remove the ReSolve Locking Drainage Catheter. Proceed with either
catheter exchange or skin closure.
ATTENTION ATTENDING PHYSICIAN: IF PATIENT WILL NOT BE FOLLOWED UP BY
YOU, IT IS RECOMMENDED THAT THE “INSTRUCTIONS FOR USE” OR THE SECTION
ON HOW TO REMOVE THE CATHETER BE ATTACHED TO THE PATIENT’S CHART.
Models: RLC-6-038, RLC-8-038, RLC-10-038, RLC-12-038, RLC-14-038, RLC-8-
038MB, RLC-10-038MB, RLC-12-038MB, RLC-14-038MB, RLC-6-REV, RLC-8-REV,
RLC-10-REV, RLC-12-REV, RLC-14-REV, RLCMB-8-REV,
RLCMB-10-REV, RLCMB-12-REV, RLCMB-14-REV, RLC-6-SFX, RLC-8-SFX,
RLC-10-SFX, RLC-12-SFX, RLC-14-SFX, RLCMB-8-SFX, RLCMB-10-SFX, RLCMB-12-
SFX, RLCMB-14-SFX
INSTRUCTIONS FOR USE
Manufacturer: Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095 U.S.A. 1-801-253-1600
U.S.A. Customer Service 1-800-356-3748
Authorized Representative: Merit Medical Ireland Ltd,
Parkmore Business Park West, Galway, Ireland
www.merit.com
402955011ZHP_001 ID 2023-07-20