Merit Medical Embedding Tool - Manual (Page 2)

EmbEddINg ThE ExTERNal PORTION
OF a PERITONEal dIalySIS CaThETER
English
INTROdUCTION
Merit Medical Systems, Inc.’s Embedding® Tool, TE-1000,
is used to temporarily embed (bury) the external portion
of a peritoneal dialysis (PD) catheter in the patient’s
subcutaneous tissue at the time of implantation. The PD
catheter is implanted and embedded in advance of the need
for peritoneal dialysis. When dialysis treatment is needed, the
catheter is retrieved (exteriorized) in a simple procedure, done
with no additional special tools.
PREFaCE
These Instructions make several assumptions that are
critical to know and understand prior to successful use of the
Embedding Tool.
1. The distal catheter coil has been optimally placed in the
peritoneal cavity for good hydraulic function, to avoid
entrapment by omentum, and to minimize catheter
migration.
2. The PD catheter has two polyester felt cuffs.
3. The distal (deep) cuff is correctly positioned within the
rectus muscle.
4. Catheter patency has been clearly established prior to the
embedding procedure.
5. The catheter has been tunneled through an exit-site.
6. The embedding procedure is done during the same
operative procedure as the initial implantation of the
PD catheter itself. There is no adequate way to sterilize
the external limb of a previously implanted catheter,
and then embed it, without significant risk of infectious
complications.
7. The retrieval procedure is assumed to be done later as a
separate procedure. The retrieval timing is determined
by the patient’s need to start dialysis and by catheter cuff
ingrowth, allowing adequate time for tissue ingrowth into
the cuffs (3 – 5 weeks).
8. The embedding and retrieval procedures are designed to be
performed by a qualified physician.
INSTRUCTIONS FOR USE
Embedding tool
PROdUCT dESCRIPTION
Each box contains one pouch with the following
components;
• Curved plastic handle, (a) with threaded tip (b)
• titanium Plug (C)
• titanium Cap (d)
b
C d
a
INdICaTIONS FOR USE
this device can be used to embed most known brands
and styles of peritoneal dialysis (Pd) catheters when the
nephrologist determines this action is in the best interest
of the patient, however, only immediately after successful
catheter implantation. the Embedding tool is indicated
for embedding the external portion of most Pd catheters
subcutaneously in anticipation of future retrieval of that
part of the catheter, provided that:
• the embedding procedure is done immediately
following Pd catheter implantation.
• Catheter patency has been completely established.
• the normally external part of the Pd catheter can be
embedded.
• the patient is a candidate for delayed onset of Pd
treatment.
• the patient is a candidate for Pd.
CONTRaINdICaTIONS FOR USE
the use of this device and technique is contraindicated if
one or more of the following conditions exist:
• the Pd catheter was implanted at a different time or
setting.
• Pd catheter patency was not clearly demonstrated prior
to embedding.
• the patient has or will receive a flex-neck® infant
Catheter.
• the patient is not a candidate for delayed onset of Pd
treatment.
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.
• this package contains small parts, assure all parts are
placed on sterile area, prior to performing procedure.
POTENTIal COmPlICaTIONS
Peritoneal dialysis potentially has a number of
complications 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.
CaUTIONS
• Catheter tubing can tear when subjected to repeated
clamping, 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 repeatedly in the same area.
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