INTENDED USE

Thal Quick Abscess Drainage Sets are intended for abscess drainage.

CONTRAINDICATIONS None known 

WARNINGS

If a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.

PRECAUTIONS

• The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of drainage catheters should be employed.

• Manipulation of product requires ultrasound. fluoroscopy. or other imaging guidance.

• Catheters should be irrigated on a routine basis to ensure function.

• Patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.

• The potential effects of phthalates on pregnant/nursing women or children have not been fully characterized and there may be concern for reproductive and developmental effects. 

INSTRUCTIONS FOR USE

1. Prep the access site with appropriate antiseptic solution and drape in a standard fashion.

2. Inject local anesthetic liberally into the soft tissue surrounding the access site.

3. Make a small skin incision, slightly larger than the diameter of the drainage catheter.

4. Under fluoroscopic, CT scan or ultrasound guidance, advance the 18 gage introducer needle into the defined abscess cavity.

5. Remove the trocar stylet and, with an attached syringe, aspirate to confirm tip position within cavity.

6. Advance the T portion of the wire guide through the needle and into the abscess cavity.

7. Remove the needle. leaving the wire guide in place. 

8. While maintaining the wee guide position, dilate the tract and opening into the abscess cavity by advancing the dilators in sequence (small to large) over the wire guide. To facilitate introduction, rotate the dilators during insertion. NOTE: It is important to advance each dilator into the abscess cavity, maintaining the position of the wire guide.

9. To prepare the drainage catheter assembly for insertion, fully advance the coaxial catheter inserter into the drainage catheter until its hub is locked into position.

10. Advance the drainage catheter/inserter assembly over the wire guide and into the abscess cavity. NOTE: To facilitate introduction, rotate the drainage catheter/inserter assembly during advancement over the wire guide. It is important to advance the drainage catheter/inserter assembly into the abscess cavity, maintaining the position of the wire guide.

11. Remove the catheter inserter and wire guide.

12. Aspirate abscess cavity contents through the drainage catheter.

13. Contrast may be injected under fluoroscopic visualization to verify positioning within abscess cavity.

NOTE: It is important that all sideports of the drainage catheter are positioned within the abscess; the most proximal sideport forms a break in the solid radiopaque stripe. In some large abscess cavities it may be useful to insert two catheters, one small and one large, so that saline may be irrigated through the small catheter and drainage collected through the large one. 

14. The catheter can now be sutured to the skin and dressed in a standard fashion, and drainage continued.