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Cook Medical Part #G13287 - FILTER, GUNTHER, RETRIEVAL SET, GTRS-200-RB, EACH
Gnther Tulip Vena Cava Filter Retrieval Set ( Filter Not Included )
The Gnther Tulip Vena Cava Filter Retrieval Set (GTRS-) for jugular approach consists of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide and a dilator. Radiopaque band provided on the outer sheath identifies precise location of the distal tip of the sheath for positioning accuracy. Refer to label for further information. The Gnther Tulip and Cook Celect Vena Cava Filters are designed to act as permanent filters. When clinically indicated, the filters may be retrieved after implantation according to the instructions provided using the Gnther Tulip Vena Cava Filter Retrieval Set (GTRS-) for jugular approach.
|Order Number||Reference Part Number||Retrieval Loop System Catheter Fr||Retrieval Loop System Length (cm)||Retrieval Sheath Fr||Retrieval Sheath Length (cm)|
- Coaxial sheath system
- Retrieval loop system
- Coons dilator
- Wire guide
- Three-way stopcock
The product has been designed for retrieval of implanted Gnther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
- Retrieval of the filter with significant amounts of trapped thrombus (greater than 25% of the volume of the cone).
- Retrieval of the filter for patients with an on-going high risk for pulmonary embolism (PE).
- This product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
- Manipulation of product requires fluoroscopic control.
- For filter retrieval, a right jugular vein approach is preferable. An approach via the left jugular vein is possible; however, there are no available data which demonstrate the safety or effectiveness of filter retrieval via the left jugular vein.
Potential Adverse Events
- Acute damage to the inferior vena cava
- Acute pulmonary embolism (PE)
- Extravasation of contrast material at time of vena cavagram
- Hematoma at retrieval vascular access site
- Thrombosis or stenosis at implant site
- Wound infection at retrieval vascular access site
Instructions for Use
Optional Retrieval Procedure
- Hold the clear Y-fitting and pull back the plastic pin vise on the wire loop to cover the loop. Tighten the screw of the clear Y-fitting to keep the loop inside the catheter. (Fig. 1)
- Puncture the right jugular vein using the Seldinger technique. Dilate the puncture site with the Coons dilator over the wire guide. Remove the dilator.
- Position a flush catheter inferior to the filter and perform a diagnostic vena cavagram.
- Exchange the flush catheter for the coaxial retrieval sheath system, advancing it over the wire guide.
- Remove the red inner coaxial catheter and the wire guide. Verify the position of the introducer by injection of contrast medium. (Fig. 2)
- Introduce the retrieval loop system through the coaxial retrieval sheath system, advance and connect the white side-arm adapter of the loop system to the sheath. The white side-arm adapter can be tightened around the catheter to prevent loss of blood. (Fig. 3)
- Loosen the screw of the clear Y-fitting to enable advancement of the loop inside the catheter. Hold the clear Y-fitting and advance the pin vise. Advance until the loop has fully expanded inside the vena cava and surrounds the filter. (Fig. 4)
- Pull back the loop until it engages the hook of the filter. (Fig. 5)
CAUTION: Do not pull on the filter beyond what is required to keep tension on the loop. Doing so may cause damage to the caval wall.
- Hold the wire loop steady with the pin vise, then push the clear Y-fitting with the catheter forward until it touches the hook. Lock the clear Y-fitting to secure the snare around the filter hook. (Fig. 6)
NOTE: If the retrieval wire loop loses its shape during the retrieval attempt, it can be removed and gently reshaped. After reshaping, clean and proceed from step 6.
- While holding the retrieval loop and clear Y-fitting steady, advance the white Tuohy-Borst side-arm adapter with the coaxial retrieval system. The filter collapses and the hooks disengage from the caval wall. (Fig. 7)
CAUTION: Advance the inner sheath over the filter to collapse it. Do not retract the loop snare. This may cause damage to the caval wall.
- When the tip of the coaxial retrieval system is at the barbed hooks, loosen the hub of the blue outer sheath, advance the outer sheath forward to cover the whole filter, and retrieve the complete assembly. (Fig. 8)
CAUTION: If the outer sheath is not advanced over the inner sheath to cover the barbed hooks, the barbed hooks may scratch or damage the caval wall.
After retrieval of filter, hospital standard of care should be followed for removing the sheath and providing hemostasis to prevent bleeding at the vascular access site.
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for onetime 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).