Merit Medical Embedding Tool User Manual

Page 3

EmbEddINg INSTRUCTIONS
STEP 1: PREPaRaTION

1. during the Pd catheter implantation procedure, implant

and tunnel the catheter according to hospital protocol

or product instructions for Use, with the superficial cuff

3.0 cm from the future exit-site (primary exit-site). the

exit-site incision should be about 1.5 cm long (equal to

three catheter widths).

2. mark the desired track of the portion of the catheter

to be embedded. the embedding track can be made

wherever there is suitable space. the path of the

subcutaneous embedding track should be straight or

curvilinear in order to facilitate subsequent catheter

retrieval.

NOTE:

a. if using a flex-neck Classic or arC™ catheter, or an

Exxtended catheter with an upper abdomen exit-site,

the shape of the embedding track should form a gentle

curvilinear turn back toward the midline.

b. if using a flex-neck Exxtended

Catheter with an upper chest

exit-site, a straight subcutaneous

embedding track down the torso

may be used.

3. determine that the external length

of the catheter to be embedded

fits the patient’s anatomy. trim

the external catheter length, if

necessary.

NOTE: if the external part of the

catheter is trimmed, make sure that

the cut is perpendicular to the catheter tube, and that the

face of the cut is smooth.

5. disassemble the titanium Plug from the Cap. do not

discard the Cap.

6. thread the Plug onto the plastic handle. be careful not

to cross-thread the Plug and handle threads.

STEP 2: EmbEddINg

1. lay the external (subcutaneous) part of the catheter

to be embedded on the patient’s abdomen to assure

proper placement.

2. mark a location on the patient’s abdomen to indicate the

end of the embedding track which also will become the

temporary secondary exit-site.

NOTE: allow for the extra length of the Plug and Cap. this

is typically 1.0 – 2.0 cm.

3. make an incision, approximately 0.5 – 0.7 cm, with a #11

blade at the secondary exit-site.

4. insert the tip of the handle, with the Plug attached,

through the secondary exit-site and through the middle

of the subcutaneous tissue toward the primary exit-site.

5. advance the handle until the entire titanium Plug is

visible.

6. dry the Plug thoroughly.

7. infuse heparin or equivalent into the catheter, as per

standard protocol.

8. insert the Plug into the catheter so that the end of the

catheter is next to (touching) the shoulder of the Plug.

NOTE:

• do not detach or separate the Plug from the handle.

• a correctly positioned catheter and Plug should form a

relatively smooth and continuous surface from catheter

to Plug.

9. secure the catheter to the Plug with a permanent, non-

absorbable suture.

10. retract the handle and catheter through the

subcutaneous tissue until the Plug is visible at (external

to) the secondary exit-site.

CaUTION: do not twist or kink the catheter.

11. hold the catheter and Plug stationary.

12. separate the handle and the Plug by rotating the

handle counter-clockwise.

CaUTION: do not twist the catheter or the Plug.

13. Verify that the catheter is not twisted by making sure

that the radiopaque stripe is consistently positioned

from the subcutaneous cuff to the end where the plug is

inserted.

14. thread the titanium Cap onto the Plug and tighten

firmly. there should be no gaps between the Cap and

Plug when completely fastened.

15. insert the Plug, with the Cap attached, and catheter into

the subcutaneous tissue.

NOTE:

• if necessary, use forceps to push the Plug into the

subcutaneous tissue.

• if necessary, use a second set of forceps at the primary

exit-site to retract the catheter into the subcutaneous

tissue.

• if the catheter (with Plug attached) seems to be too

close to the secondary exit-site, enlarge the secondary

exit-site incision and position the Plug deeper into the

subcutaneous tissue, or trim off additional length of the

catheter and reinsert the Plug.

CaUTION:

• do not retract the catheter more than 2.0 cm back

through the primary exit-site.

• do not dislodge or reposition the superficial

subcutaneous cuff.

16. Carefully verify that:

• the catheter is not kinked or twisted.

• the subcutaneous cuff is in the proper location relative

to the future primary exit-site.

• the embedding track forms a straight or curvilinear

path that will facilitate pulling the catheter from the

subcutaneous path during the retrieval procedure.

17. Close the original catheter insertion incision, as well

as the primary and secondary exit-site incisions, as per

normal hospital protocol.