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Merit Medical ReSolve Locking Drainage Catheter User Manual

Page 3

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Figure 3

Note: If the catheter needs to be repositioned, unlock the

suture locking mechanism by rotating the arm proximally

to the point of resistance.

Precaution: Do not rotate the suture locking mechanism

beyond the point of resistance. Rotating the suture locking

mechanism beyond the point of resistance will not release

the suture to allow the pigtail to straighten upon removal.

8. Once placement is confirmed, and the suture locking

mechanism has been rotated to the most distal position,

press the suture locking mechanism into the hub to secure

it. The suture locking mechanism is now locked into posi-

tion. See Figure 4.

Figure 4

9. The ReSolve Locking Drainage Catheter is now ready to

be connected to appropriate drainage bag, tubing or dead

end cap.

WARNING: If using alcohol to clean the catheter hub, allow

sufficient time for alcohol to dry before connecting the

drainage tubing or dead end cap.

WARNING: DO NOT over tighten the connection between

the drainage catheter and drainage tubing or dead end

cap.

Note: A flush regimen should be designed for the circum-

stances of each patient and the protocol of the physician.

Note: Instruct patient or other healthcare personnel in

appropriate device function and/ or maintenance.

INSTRUCTIONS FOR USE OPTION 2:

SELDINGER ENTRY TECHNIQUE OR GUIDE WIRE EX-

CHANGE

1. Remove the stiffening cannula and trocar stylette assem-

bly from catheter.

2. Ensure that the distal portion of the catheter is wet prior

to placement. Wet the distal portion of the ReSolve Locking

Drainage catheter prior to use with sterile water or saline.

Keep the distal portion of the catheter wet during place-

ment.

WARNING: DO NOT wipe catheter with dry gauze or any

solvents because it may damage the catheter coating.

3. Slide pigtail straightener along distal portion of catheter

to straighten curve prior to placing the stiffening cannula

into the catheter. Place the stiffening cannula into the

catheter and tighten the luer lock fittings. See Figure 5.

Figure 5

4. Remove pigtail straightener from catheter prior

to insertion.

5. Place catheter/cannula assembly over appropriate guide

wire and advance into the fluid collection site. The catheter

accommodates a 0.038” (0.97 mm) wire. See Figure 6.

Note: Placement should be confirmed with diagnostic

imaging.

Figure 6

6. After placement is confirmed, remove the stiffening

cannula and guide wire.

7. To engage the suture locking mechanism: Pull the suture

until desired pigtail is formed. Rotate the suture locking

mechanism distally to hold the suture in place. See Figure 7.

Figure 7

Note: If the catheter needs to be repositioned, unlock the

suture locking mechanism by rotating the arm proximally

to the point of resistance.

Precaution: Do not rotate the suture locking mechanism

beyond the point of resistance. Rotating the suture locking

mechanism beyond the point of resistance will not release

the suture to allow the pigtail to straighten upon removal.

8. Once placement is confirmed, and the suture locking

mechanism has been rotated to the most distal position,

press the suture locking mechanism into the hub to secure

it. The suture locking mechanism is now locked into

position. See Figure 8.

Figure 8

9. The ReSolve Locking Drainage Catheter is now ready to

be connected to appropriate drainage bag, tubing or dead

end cap.

WARNING: If using alcohol to clean the catheter hub, allow

sufficient time for alcohol to dry before connecting the

drainage tubing or dead end cap.

WARNING: DO NOT over tighten the connection between

the drainage catheter and drainage tubing or dead end

cap.

Note: A flush regimen should be designed for the circum-

stances of each patient and the protocol of the physician.

Note: Instruct patient or other healthcare personnel in

appropriate device function and/ or maintenance.

CATHETER EXCHANGE, REPOSITIONING OR REMOVAL

1. Disconnect catheter from drainage bag, tubing or dead

end cap.

2. To release the pigtail loop choose one of the following

options:

Option 1:

• Using the Repositioning Tool align the opening of the

round section of the Repositioning Tool in line with the

handle of the suture locking mechanism.

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F

10F

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F

10F