Merit Medical PD Percutaneous Kit IFU User Manual

PERCUTANEOUS

PD CATHETER

IMPLANTATION SYSTEM

INSTRUCTIONS FOR USE

VP – 511 and VP-511M

Implantation System for Peritoneal Dialysis Catheters

Product Description:

Implantation System Components:

• 0.038” Guide Wire

• 12 French Dilator

• 14 French Dilator

• 18 Gauge Introducer Needle

• 18 French Peelable Introducer Sheath

• Cu Implantor™

• Faller Trocar

• Scalpel

• 10 mL Syringe

• 4x4 Gauze

• Clip

Indications for Use:

The Percutaneous Implantation Kit can be used to implant
a peritoneal dialysis catheter in patients who are suitable
candidates for peritoneal dialysis therapy.

Contraindications:

• Do NOT use if the patient is not a suitable candidate for
peritoneal dialysis therapy.

Px Only: Caution: Federal (USA) law restricts this device to
sale by or on the order of a physician.

Precautions:

• Read manufacturer’s instructions prior to use.

• Contents are sterile (via ethylene oxide). 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.

• Do not use after expiration date.

• The medical techniques, procedures, and potential
complications stated herein do NOT give full and/
or complete coverage or descriptions. They are not a
substitute for adequate training and sound medical
judgment by a physician.

• Use an aseptic procedure to open the package and to
remove the contents.

Potential Complications:

Peritoneal Dialysis catheter implantation procedures have
inherent risks associated with their use. All such risks
apply to the use of the Percutaneous Implantation System.
Peritoneal dialysis potentially has a number of complica­tions that may occur, which generally are not caused by
the implantation, but may aect the quality of therapy.
These complications may include, but are not limited to,
the following:

• Infections (exit-site or tunnel)

• Peritonitis

• Sepsis

• Bowel perforation

• Leakage (initial or latent)

• Fluid ow obstruction (inow or outow)

• Bleeding (subcutaneous or peritoneal)

• Ileus

• Proximal exit cu erosion

• Distal (rectus/deep) cu erosion

• Risks normally associated with peritoneoscopic and
laparoscopic procedures

• Allergic reaction

• Abdominal pain

• Infusion pressure/pain

• Organ erosion

• Genital edema

Catheter Implantation Site Options

An Implantation Stencil may help to achieve consistent ef­fective catheter placement and assure proper coil location.
Implantation Stencils (Figure 1) are sold separately with the
Flex-Neck® Catheter kits.

PD Catheter Implantation Site Options

Locate preferred implantation, tunnel, and exit sites as
indicated by an appropriate Implantation Stencil (Figure 2).
Please see anatomical landmarks as indicated in Figure 3.

Flex-Neck® Adult PD Catheter

IMPLANTATION STENCIL

Classic Exit
Cu Site

Rectus Cu Site

Primary Incision Site

®

Use with Flex-Neck
Classic & Arc™ Adult
PD Catheter ONLY

For directions, see

Place on Patient’s

Instructions for Use

Cranial Border of

the Pubic Symphysis

Figure 1 Figure 2-Stencil on body
Implantation Stencil

Figure 3 – Potential lower catheter implantation sites

A. Umbilicus
B. Iliac crest
C. Inferior and superior epigastric arteries

1. Left, lateral border of rectus sheath, 2-3 cm below
umbilicus

2. Right, lateral border of rectus sheath, 2-3 cm below
umbilicus

3. Medial border of rectus sheath, 2-3 cm below umbilicus

NOTE: Implantation sites should be above superior iliac
crest.

WARNING: Do NOT implant the catheter or place the
exit-site in the patient’s skin folds or beltline.

Patient Preparation:

1. Operating personnel should perform a surgical scrub,
and use sterile hat, mask, gown and gloves according to
hospital protocol.

2. The patient should also wear a mask.

3. Attach appropriate patient monitors and sedate pa­tient.

4. Prepare abdomen and drape patient in standard sterile
manner.

5. Use ultrasound at the intended entrance site to identify
any exclusionary pathology. Duplex ultrasound may
also be useful to identify proper catheter placement site
and avoid injury to the inferior epigastic vessels prior to
needle placement.

6. Anesthetize the proposed tissue tract and primary
catheter insertion site with proper local anesthetic.

Percutaneous Insertion of Introducer Sheath:

7. Make a 2-3cm long horizontal skin incision at selected
catheter implantation site.

8. Use a blunt dissection and cautery device as necessary
to maintain hemostasis. See gure 4.

Figure 4

Warning: If a bowel perforation is identied, the procedure
should be abandoned and the patient should be treated
with antibiotics for an appropriate duration before at­tempting a repeat catheter placement.

13. Once proper access to the peritoneal space is achieved
and conrmed via contrast, remove syringe from intro­ducer needle and insert the exible end of the guide
wire through the introducer needle. Direct the wire into
the caudal and posterior position. Advance the wire
as appropriate under uoroscopy into the peritoneum.
The guide wire should advance easily into the peritone­al space.

Note: Optional: A hydrophilic, Amplatz or super-sti guide
wire (sold separately) can also be used. Normal saline may
also be infused, when necessary, in order to increase the
space between the abdominal wall and the bowel loops.

Warning: Saline infusion is not recommended in the
presence of ascites.

1

1

Warning: Forcible advancement of the guide wire against
resistance can result in internal organ injury and should be
avoided.

14. Withdraw the introducer needle, leaving the guide wire
positioned in the peritoneum.

15. Further advance the guide wire to the optimal position
in the pelvic gutter.

16. To accommodate catheter passage into the peritoneal
cavity, dilate the rectus muscle with the 12 French and
14 French dilators respectively, under uoroscopic
guidance.

17. Verify that the dilator and introducer sheath are locked
together to prevent separation during insertion.

9. If appropriate, the implantation of the deep cu into
the rectus abdominus muscle can be aided by creating
a small puncture or fasciotomy into the supercial
rectus fascia with a hemostat or scalpel prior to needle
placement.

10. At a 30-45 degree angle from horizontal, using
ultrasound guidance, advance the introducer needle
through the anterior rectus sheath, rectus muscle and
through the posterior rectus sheath.

Note: A non-vascular micropuncture set (sold separately
and available from Merit Medical) may be used to access
the peritoneum. If using a non-vascular micropuncture
set, assure the length is adequate for peritoneal access and
follow manufacturer’s instructions for use.

11. Once access to the peritoneal space is obtained, attach
a 10 mL syringe containing appropriate iodinated con­trast material to the needle using exible clear tubing
(sold separately).

12. Under uoroscopy, verify needle placement into the
peritoneal space by identifying the free ow of contrast
outlining regional bowel loops. An amorphous, irreg­ular or striated appearance of injected contrast may
indicate that the needle tip is inappropriately located in
the bowel mesentery, greater omentum, preperitoneal
space or rectus abdominus muscle.

Warning: Do not use barium-based contrast.

Note: Contrast media should outline bowel loops. Contrast

identied within a bowel loop may indicate bowel perfo­ration.

Figure 5

18. Under uoroscopy, advance the 18 French peelable
introducer sheath over the guide wire, gently twisting
it back and forth to assist with passage through the
tissue.

Warning: In order to avoid internal injury, care should be
taken to avoid advancing the introducer or dilators beyond
the tip of the guide wire.

Warning: Care should be taken to avoid creating a kink into
the guide wire with the introducer.

19. Once the sheath is in place, gently remove the dilator
from the peelable introducer sheath. If using the
“Implantation Stylette Technique” as noted below, the
peelable sheath and wire can be removed simultane­ously.

Caution: Do not force the introducer into the peritone­um. Take care not to insert further than necessary for the
patient’s size and access site.

Preparing the catheter

20. Prepare the catheter by soaking it in sterile saline,
and squeeze the air out of the cus by rotating the
submerged cus between ngers. See Figure 6.