Cook Medical G04474 - GIAS-100 COPE GASTROINTESTINAL SUTURE, EACH

Cook Medical G04474 - GIAS-100 COPE GASTROINTESTINAL SUTURE, EACH

Cope Gastrointestinal Suture Anchor Set

The Cope Gastrointestinal Suture Anchor Set consists of an introducer needle with a preloaded suture anchor, a special .018/.035 inch wire guide with a spring coil tip, and a second suture anchor in a loading cannula.

Features and Benefits

Used for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

• Flexible "spring coil" suture anchor enhances patient comfort
• Both the introducer and loader come with one preloaded suture anchor
• Braided material increases suture resilience

Components

• Introducer needle
• Introducer cartridge
• Suture anchors
• Special straight wire guide

Intended Use

The Cope Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters.

MRI Information

Non-clinical testing has demonstrated that the Cope Gastrointestinal Suture Anchor is MR Conditional according to ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. A patient with this metallic anchor may be scanned safely anytime after placement under the following conditions.

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial magnetic gradient of 1600 Gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning or less (i.e., per scanning sequence)

Static Magnetic Field

The static magnetic field for comparison to the above limits is the static magnetic field that is pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating

In non-clinical testing, the Cope Gastrointestinal Suture Anchor produced a maximum temperature rise of 1.6 C during 15 minutes of MR imaging (i.e., for one scanning sequence) performed in a MR 3.0 Tesla System (General Electric Excite, HDx, Software 14X.M5) at an MR system reported whole-bodyaveraged SAR of 2.9 W/kg (associated with a calorimetry measured wholebody-averaged value of 2.7 W/kg).

Image Artifact

MR image quality may be compromised if the area of interest is within approximately 25 mm of the position of the Cope Gastrointestinal Suture Anchor as found during non-clinical testing using T1-weighted, spin echo and gradient echo pulse sequence in a 3.0 Tesla MR system (Excite, General Electric Healthcare, Milwaukee, WI). Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic anchor.

Precautions

• The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of gastrointestinal suture anchors should be employed.
• Manipulation of the product requires fluoroscopic control.
• Withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through the needle tip may result in breakage.

Instructions for Use

• Insufflate the stomach with approximately 500 cc of air through a nasogastric tube.
• Localize the puncture site and administer local anesthetic to the peritoneum.
  NOTE: The preferred puncture site into the gastric lumen is at the junction of the left anterior rib cage and the lateral border of the rectus abdominis muscle, provided there is no interposition of the liver or colon.
• Attach a 10 ml syringe, half filled with contrast medium, to the introducer needle that has been preloaded with the suture anchor.
• Advance the introducer needle through the anterior abdominal wall and then rapidly thrust the needle another 2-5 cm into the air-filled stomach. Air should be freely aspirated. Injection of contrast medium under fluoroscopy will aid in confirming proper intragastric needle position.
• Remove the 10 ml syringe from the needle hub. While maintaining slight tension on the trailing suture, introduce the distal spring coil .035 inch portion of the wire guide into the needle and use it to push the suture anchor out of the needle into the stomach cavity. Maintaining slight tension on the suture during anchor introduction will prevent it from bunching and lodging within the needle lumen.
• Remove the introducer needle over the wire guide and trailing suture needle. The .018 inch part of the wire guide must be positioned adjacent to the suture needle to allow clearance and removal of the introducer needle.
• With the wire guide still in position, apply traction to the suture to pull the anterior wall of the stomach against the abdominal wall.
• While maintaining traction on the suture anchor, secure the suture to the skin under slight tension.
• Remove the wire guide.
• To place the second suture anchor, reintroduce the introducer needle as described in step 4.
• Advance the loading cannula containing the second suture anchor into the hub of the introducer needle.
• Advance the wire guide through the cannula into the introducer needle, pushing the second suture anchor into the abdominal cavity.
• Follow steps 6 through 8 with the second suture anchor.
• The wire guide may now be used to facilitate passage of fascial dilators and introduction of the gastrostomy catheter. Take care not to advance the entire distal spring coil segment of the wire guide into the abdominal cavity.
  NOTE: The sutures may be left in place for up to two weeks while tract formation occurs, or cut earlier when deemed appropriate by the physician. Cutting the sutures releases the anchors into the stomach, allowing their passage via the gastrointestinal system.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or 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.

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).