Contraindications - COOK Medical Nathanson Gebrauchsanweisung

NATHANSON TRANSCYSTIC BILE DUCT STONE
EXPLORATION PACK
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or a properly licensed practitioner).
DEVICE DESCRIPTION
The Nathanson Transcystic Bile Duct Stone Exploration Pack is packaged
preloaded and sterilized. The preloaded assembly includes: (Fig. 1)
• 5.5 French, 70 cm long radiopaque nylon catheter with a soft tip and five
visual markers spaced 2 cm apart, starting at the tip of the catheter.
• 75 cm long, four-wire Flatwire Stone Extractor and plastic pin vise.
• "Y" Tuohy-Borst Adapter
This set is designed for use through a laparoscopic cholangiography
instrument clamp (e.g., Reddick-Olsen Clamp) with a minimum 6 French
working channel.
INTENDED USE / INDICATIONS FOR USE
The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for
extraction of bile duct stones via laparoscopic transcystic approach.

CONTRAINDICATIONS

Extraction of bile duct stones greater in diameter than the cystic duct.
WARNINGS
• Rigidity of the catheter assembly may cause cystic duct and bile duct
perforation during biliary cannulation, especially when acute inflammation
is present or deployment past an impacted stone is encountered.
• Wire deployment within the ampulla of Vater and duodenum may entrap
mucosa anchoring the catheter assembly in situ, potentially injuring
mucosa and triggering pancreatitis.
• This device is designed for the removal of stones and debris ranging from
0.3 cm to 1.0 cm in diameter.
• Common bile duct exploration and alternative surgical intervention may
need to be performed if basket becomes impacted after capturing a distal
common bile duct stone.
• This device contains nickel, which may cause an allergic reaction in
individuals with nickel sensitivity.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced in
the anatomy of the biliary tree and stone extraction techniques.
• It is important that the surgeon and operating room personnel become
completely familiar with the operation of this device prior to use.
• Adequate lead shielding for all operating room staff is required during
fluoroscopic X-ray screening.
• Patient lead shielding is necessary if any suspicion of early pregnancy
exists.
• Kinking of the catheter's soft tip may obstruct advancement of the
extractor.
• Stone extraction via the cystic duct may lead to stone fragmentation.
• Withdrawal of the extractor back into the catheter, in preparation for
biliary re-cannulation, may lead to entanglement in the laparoscopic
cholangiography instrument clamp's tip mechanism, damaging the wires.
• Avoid deploying the extractor in the ampulla of the distal common duct.
(Fig 6)
POTENTIAL ADVERSE EVENTS
• Fragmentation of stones in the bile duct
• Ampullary edema
• Bile duct perforation
• Pancreatitis
• Retained bile duct stones
• Retained stones in the peritoneal cavity
• Splitting of cystic duct
• Retained choledochololithiasis
• Biliary leak
• Late biliary strictures
CLINICAL STUDY
A 2007 retrospective study evaluated 160 consecutive patients with bile
duct stones (Taylor et al, 2007). The Nathanson Trancystic Bile Duct Stone
Exploration Pack (previously known as Nathanson Basket Kit) was used for
transcystic exploration when 1 cm diameter stones were observed in the
common bile duct. 131 cases (82%) achieved successful laparoscopic common
bile duct exploration (LCBDE). 29 cases required additional intervention (i.e.,
ERCP) to achieve clearance at the time of surgery. Major morbidity occurred in
13.8%, including biliary leak in 7.5% and one late biliary stricture (0.6%).
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ENGLISH