Merit Medical Faller Trocar - Manual (Page 2)

FALLER TROCAR
For Implantation of Peritoneal Dialysis Catheters
english
PRODUCT DESCRIPTION
each pouch contains one plastic or stainless steel Faller
trocar.
staInless steel
plastIC
INDICATIONS FOR USE
the Faller trocar is used to create an antegrade subcutane-
ous tunnel for a peritoneal dialysis catheter from the initial
implantation site to the preferred exit-site. It separates the
tissue as it leads the catheter through to the skin exit-site.
CONTRAINDICATIONS FOR USE
the Faller trocar is contraindicated for use if the distal part
of the catheter is not implanted properly.
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 potentially has a number of complica-
tions that may occur, which generally are not caused by the
implantation, but may affect 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 flow obstruction (inflow or outflow)
• Bleeding (subcutaneous or peritoneal)
• Ileus
• proximal exit cuff erosion
• Distal (rectus/deep) cuff erosion
• risks normally associated with peritoneoscopic and
laparoscopic procedures.
• subcutaneous hematoma
• Dislocation of the previously implanted proximal part
of the catheter
CAUTIONS
• the Faller trocar is very sharp and can create severe
hematomas on the patient or injure the user if not used
correctly by qualified medical personnel.
• Do not use the Faller trocar if the sharp tip is damaged in
any way or has a burr at the sharp tip.
• this Instruction for Use does not address the
implantation of the catheter. each style of catheter
or implantation kit used will have its own set of
implantation instructions, which should be followed.
• this Instruction for Use is only for the Faller trocar,
which is used after the intraperitoneal part of the
catheter has been implanted.
• the desired tunnel track and exit-site should be marked in
advance to serve as a guide for the trocar and catheter.
• Do not twist or kink the catheter.
INSTRUCTIONS FOR USE
1. select and mark an appropriate exit-site on the skin.
refer to the implantation kit or catheter’s specific
implantation instructions for details.
2. If conscious sedation was used to implant the catheter,
anesthetize the planned exit-site. optional: anesthetize the
planned tunnel track.
3. slide the proximal end of the catheter over the barbed
end of the Faller trocar, onto the indented section of the
trocar past the barb.
4. secure the catheter with a suture by tying the suture
around the catheter, holding strength during the tunneling
process.
5. Insert the sharp end of the Faller trocar into the initial
implantation site, aiming the sharp tip toward the planned
exit-site.
6. advance the sharp tip of the Faller trocar along the
planned track. Do not twist the catheter.
7. When the Faller trocar tip is close to the exit-site, make a
stab incision not to exceed 5.0 mm with a #11 blade at the
exit-site.
8. advance the Faller trocar through the exit-site incision.
Do not twist or kink the catheter.
9. pull the catheter through the tunnel, and out through
the exit-site.
CAUTIONS:
• Verify that the catheter is not twisted or kinked.
• Do not change the shape of the tunneled catheter track
from the track made by the Faller trocar.
• Do not use excessive force as the catheter is pulled.
excessive force can permanently damage the integrity
of the catheter walls or dislocate the distal part of the
catheter.
• If resistance is noted, carefully use a hemostat inserted
into the primary implantation site to open the tunnel
track for the exit cuff.
• never use a hemostat at the exit-site.