Cook Medical G21664 - BALLOON, EXTRACTION, ESCORT II, EBL-8.5-200, EACH

Cook Medical G21664 - BALLOON, EXTRACTION, ESCORT II, EBL-8.5-200, EACH

Escort II Double Lumen Extraction Balloon

Escort II Double Lumen Extraction Balloon - Used for endoscopic removal of biliary stones.

Intended Use

Notes: This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease. Do not use this device for any purpose other than stated intended use. If package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. Please notify Cook for return authorization. Store in a dry location, away from temperature extremes. Use of this device restricted to a trained healthcare professional.

Contraindications

Those specific to ERCP and any procedures to be performed in conjunction with balloon stone extraction. Use of this natural latex rubber balloon is contraindicated in patients with a known hypersensitivity to latex.

Potential Complications

Those associated with ERCP include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest. Those that can occur during endoscopic balloon extraction include, but are not limited to: stone impaction, localized inflammation, pressure necrosis.

Precautions

Refer to package label for minimum channel size required for this device.

Instructions for Use

1. Verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating balloon with air only. If any leakage is detected, do not use. Notify Cook for return authorization. Note: Stopcock is in open position, allowing access to balloon, when two arms are aligned with catheter and syringe. To maintain balloon inflation, turn stopcock arm 90.
2. With duodenoscope elevator open, advance deflated balloon in short increments through accessory channel until it is visualized exiting scope.
   Note: Prior to advancing device over a pre-positioned wire guide, close Tuohy-Borst adapter, if applicable, flush wire guide lumen with sterile water or saline to facilitate advancement. If applicable, remove injectable stylet. If applicable, re-open Tuohy-Borst adapter to allow advancement of device over wire guide.
3. Prior to advancing device into duct, flush sideport of injectable stylet or injection port, as applicable, with contrast to expel all air. Note for double lumen devices: To inject over a pre-positioned wire guide, a side arm adapter must be attached to color-coded wire guide hub.
4. Position deflated balloon above stone to be removed.
   Note: If more than one stone is to be removed, extract one stone at a time. Note for triple lumen devices: Contrast may be injected through injection port with wire guide in place. Note for Howell DASH Balloon: Contrast may be injected through injection port with wire guide in place. Tuohy-Borst adapter should be securely tightened around wire guide prior to injecting to prevent backflow. Adapter may be adjusted to allow wire guide movement while maintaining fluid seal.
5. After verifying desired position of balloon, open stopcock by lining it up with lumen. Attach pre-measured syringe to inflation port, then inflate balloon with air only. Inflation may be maintained by turning the stopcock arm 90 to closed position. Note for multiple sizing balloons: Inflate as indicated on syringe. For 8.5 mm, inject to 12 mm mark then pull back gently to 8.5 mm mark and lock stopcock.
6. Using fluoroscopic visualization and keeping endoscope elevator open, gently withdraw inflated balloon toward papilla.
   Warning: Do not exert excessive pressure on ampulla while extracting stones. If stone does not pass easily, reassess need for sphincterotomy.
7. Repeat extraction process, one stone at a time, until duct is clear.
8. Once balloon is visualized in duodenum, turn stopcock to open position and deflate balloon.
9. Loosen Tuohy-Borst adapter (if applicable) and withdraw deflated balloon from accessory channel. Note: When removing balloon from endoscope, wire guide may be left in place to facilitate introduction of compatible wire-guided devices.