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FANELLI CHOLANGIOGRAPHY CATHETER
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Fanelli Cholangiography Catheter has a flexible distal tip with smooth,
atraumatic edges, which facilitate the passage of the catheter into the
cystic duct. The integrated wire guide allows passage of the catheter into
difficult, small or tortuous ducts. The centimeter markings provide for
accurate positioning. The three-way adapter allows saline for flush, contrast
for cholangiography, and a wire guide all to be used simultaneously and
seamlessly, reducing the risk of introduction of air.
INTENDED USE
The Fanelli Cholangiography Catheter is intended for diagnostic evaluation of
the bile ducts during laparoscopic cholecystectomy procedures.
CONTRAINDICATIONS
None known
PRECAUTIONS
• This product is intended for use by physicians trained and experienced
in placement of cholangiography catheters. Standard cholangiography
techniques should be employed.
• It is recommended that all wire exchanges be performed using
fluoroscopic guidance, to maximize patient safety.
• The surgeon should anatomically verify the cystic duct location.
• The cystic duct incision should be of sufficient size to allow introduction of
the catheter tip, and should demonstrate the egress of a small amount of
bile, confirming appropriate location.
• Check the tightness of all screw connections and stopcocks.
• Note the labeling on the three-way adapter top, indicating placement of
syringes with saline and contrast.
• The syringes should be held with the plunger slightly elevated to prevent
the injection of air that might be present in the syringe barrel during
cholangiography.
• 20 ml syringes with Luer lock adapters are recommended.
• 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.
WARNINGS
• It is vital that appropriate placement be confirmed before catheter is
introduced.
• Care should be taken when advancing the catheter, as dissection in a false
plane might occur, and perforation or tearing of the duct could occur if
excessive force is used.
• Care should be taken when introducing the wire guide; use of excessive
force may result in perforation of the duct.
• The wire passage port of the cholangiography catheter should not be
pointed toward the face, in case the injection pressure overcomes the
pressure relief feature of the silicone valve.
INSTRUCTIONS FOR USE
The catheter can be used through a laparoscopic cholangiogram clamp or
introduced through a separate site and anchored with a free tie or partially
occluding clip.
1. Fill a 20 ml Luer lock syringe with saline solution and attach it to the
saline port of the cholangiography catheter.
2. Close the contrast stopcock and flush the catheter with approximately
5-10 ml of saline.
3. Fill a 20 ml Luer lock syringe with radiographic contrast material and
attach it to the contrast port of the cholangiography catheter.
4. Open both stopcocks, and inject a small amount (1 ml) of saline, which
will flow back through the three-way adapter top to enter the contrast
syringe. This removes additional air from the system.
5. Close the contrast stopcock, leaving the saline stopcock open for flushing
during catheter insertion if necessary.
6. Position the wire guide so that its tip is within the flexible tip of the
cholangiography catheter.
7. When using the Fanelli Cholangiography Catheter through a laparoscopic
cholangiogram clamp, load the catheter, positioning its tip within the
anchoring jaws of the clamp to prevent bending of the catheter's flexible
tip during advancement through the laparoscopic trocar valve.
8. Introduce the cholangiography catheter into the opening created in the
cystic duct, flushing with saline as necessary to confirm placement.
NOTE: If necessary, the wire guide can be advanced into the cystic duct
first and the cholangiography catheter then advanced over the wire
guide.
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