Preparation For Use; How Supplied - COOK Medical Nathanson Gebrauchsanweisung

INSTRUCTIONS FOR USE

Preparation for Use

1. Remove contents from the package in a sterile manner and place on a
sterile field.
2. Examine the contents to ensure that all components are intact and
assembled correctly.
3. Withdraw the extractor back into the catheter approximately 5 cm
by grasping the pin vise and stiff end of the exposed wire and gently
pulling backwards. Note the position of the pin vise in relation to the
valve. Maintain this position to ensure that the tip of the extractor is not
exposed at the distal end of catheter when inserted into the patient.
4. Gently tighten the Tuohy-Borst adapter to ensure that flush does not
escape and to stabilize the wire extractor for insertion. Do not over-
tighten on the wire.
5. Flush the catheter system with sterile saline through the side-arm adapter
to remove any air bubbles.
6. Load the assembly into a pre-positioned, open-tipped laparoscopic
cholangiography clamp, ready for use.
Access and Cholangiography
1. Initiate standard laparoscopic exposure with umbilical and three
subcostal ports.
2. During dissection of the cystic duct, note the duct size and dissect down
closer to the common hepatic duct to avoid spiral valves. (Fig. 2)
3. Using an appropriately sized open-ended cholangiography catheter
under fluoroscopic imaging, note the cystic duct course into the common
bile duct (CBD) (direct, into the right hepatic duct, or very low down near
the ampulla) and the CBD diameter, coupled with the size, shape and
number of bile duct stones. NOTE: Identification of stones in the biliary
tree proximal to the cystic duct entry may be reason to choose either
choledochotomy or ERCP clearance.
4. If there is uncertainty in interpreting images, it may be helpful to
wash contrast out with saline and re-run the cholangiogram. Imaging
during the washout phase can be helpful, as during the contrast run, to
demonstrate details of the stones.
Transcystic Stone Extraction
1. Once bile duct stones have been confirmed and are considered suitable
for transcystic extraction, exchange the in situ cholangiography catheter
for the pre-prepared Nathanson 5.5 French catheter with pre-loaded
extractor, loaded into an appropriate laparoscopic cholangiography
instrument clamp. Please refer to the "Preparation for Use" section of
these Instructions for Use for information on preparing the catheter.
2. Only after the catheter has passed the stone, loosen the Tuohy-Borst
adapter and advance extractor for stone capture.
3. Under fluoroscopic monitoring, advance the catheter tip just beyond the
first stone, then advance the extractor through the catheter until its tip
emerges. (Fig. 3)
4. Hold the extractor's position steady and withdraw the catheter and
Tuohy-Borst adapter until the adapter abuts the extractor handle. This will
allow the extractor to deploy around the stone. (Fig 4)
5. Engage the extractor wires around the stone by manipulating the
extractor wires with the extractor handle. Upon capturing the stone,
slowly withdraw the extractor and catheter as a unit from the cystic duct.
(Fig. 5)
6. Place the stone in a suitable area of the abdominal cavity for its later
removal, along with the gallbladder. NOTE: Calculi may be fragmented
upon removal. Further visual inspection with a small-caliber, flexible
choledochoscope may be helpful to ensure complete clearance of the
stone.
7. After stone removal, patency of CBD can be confirmed by injecting
contrast media through the side-arm of the adapter through the catheter
and into the CBD.
8. For multiple stones, repeat the process in sequence, working down
toward the ampulla. CAUTION: Avoid deploying the extractor in the
ampulla of the distal common duct, as its mucosa may catch in the
extractor wires, potentially inducing acute pancreatitis or resulting in
long-term ampullary scarring. Early resistance upon extractor withdrawal
and fluoroscopic inversion of the ampulla and the distal bile duct are
indicators of entanglement. (Fig. 7) Should this occur, discontinue
catheter withdrawal and disentangle the ampulla mucosa from the
extractor wires by pushing the extractor and the tip of the catheter into
the duodenum. (Fig. 8) Withdraw the extractor into the catheter, and
withdraw the catheter into the bile duct.

HOW SUPPLIED

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened and undamaged. Do not use
the product if there is doubt as to whether the product is sterile. Store in a
dark, dry, cool place. Avoid extended exposure to light. Upon removal from
package, inspect the product to ensure no damage has occurred.
6