Merit Medical Flex-Neck ExxTended Catheter - Manual (Page 2)

flex-neck exxtended
catheter kIt
Instruc tIons for use
table of contents
section a – Instructions for Flex-Neck exxTended catheter
Implantation Stencils kit
section B – Instructions for lower catheter Implantation for
upper abdomen and upper chest exit-Site
section c – Instructions for upper abdominal catheter: Sizing,
connecting and placement
section d – Instructions for upper chest catheter: Sizing,
connecting and placement
section e – catheter connector Instructions
Product description
each Flex-Neck exxTended catheter kit contains a sealed tray
and a separate sealed pouch.
tray contents:
• lower catheter
• upper catheter
• Titanium tube-to-tube connector, double barbed
(internal use)
• Tape measure
• Flex-Neck® exxTended™ catheter Implantation Stencil Set
• Surgical marking pen
• lubricating gel, water-soluble
• plastic catheter connector (external use)
• plastic catheter connector cap (external use)
Pouch contents:
• Tunneling Tool, curved
• measuring rod
Indications for use
If a patient is a suitable adult candidate for peritoneal dialysis
(pd) therapy, the Flex-Neck exxTended peritoneal dialysis
catheter can be implanted either surgically, laparoscopically, or
peritoneoscopically for acute or chronic peritoneal dialysis.
Stencils sold with the device, and marketed separately, will be
used to assist the physician to locate the optimum primary
implantation site and the optimum catheter exit site for the
Flex-Neck exxTended catheter.
contraindications for use
do not use the exxTended catheter if the patient is not a suit-
able candidate for peritoneal dialysis therapy.
WarnIng:
The upper chest exit-site location of the exxTended catheter
should not be used if the patient has had breast implantation
or breast reconstruction, or has a tracheostomy. however, this
group of patients may be suitable candidates for the upper
abdomen exit-site location of the exxTended catheter.
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 pack-
aging is opened, damaged or broken.
• For single patient use only. do not reuse, reprocess, or rester-
ilize. 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 compli-
cations stated herein do NoT give full and/or complete cov-
erage 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 complications
that may occur, which generally are not caused by the implanta-
tion, 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 surgical procedures.
cautions:
• do no twist or rotate catheter during the implantation proce-
dure.
• exxTended Stencils cannot be used with other brands of pd
catheters.
• enclosed Stencils are designed for Flex-Neck, exxTended,
coiled adult peritoneal dialysis catheters oNlY.
• do NoT use exxTended stencils with Flex-Neck adolescent,
pediatric, or Infant catheters.
• do NoT sterilize or reuse Stencils.
• catheter tubing can tear when subjected to repeated clamp-
ing, serrated-jaw forceps, excessive force, or rough tools.
• do NoT use forceps with a serrated jaw.
• do NoT use excessive force to lock the forceps closed.
• use oNlY smooth-jawed forceps or equivalent.
• do NoT clamp the catheter, or repair tubing repeatedly in
the same area.
• do NoT clamp near the connector.
use only catheter connectors and repairs kits which are specif-
ically labeled and approved for use with Flex-Neck peritoneal
dialysis catheters. approved catheter connectors and repair kits
can be ordered directly from merit medical Systems, Inc.
For best results, use the Stencils included with each catheter
kit. If not using the included Stencils, follow generally accepted
standard hospital protocols to make arcuate-shaped tunnels.
cautions: use the radiopaque stripe as a guide to keep the cath-
eter straight. The catheter must not be twisted or rotated during
the implantation procedure. any twist or rotation in the catheter
can lead to kinks, migration, and/or occlusion.
assumptions to successful exxtended™
catheter Implantation
as with any medical/surgical procedure, there are a number of
assumptions and prerequisites made for the successful implan-
tation of the exxTended catheter.
1. The implanting physician has had a reasonable number of
successful peritoneal dialysis catheter implantations, preferably
via laparoscopic or peritoneoscopic implantation. The exxTend-
ed catheter can also be implanted via a cut-down method or
guide-wire technique.
2. preferably, the patient’s lower abdomen and exit-site area
either upper chest or upper abdomen have been previously