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Brief Summary Document - HCP
Product
Stone Cone Nitinol Urological Retrieval Coil – IFU 51751852
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended use/Indications for use
The Stone Cone Coil is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract.
Contraindications
The Stone Cone Coil is contraindicated for patients with:
- Sepsis
- An untreated urinary tract infection
- Anticoagulation or uncorrected bleeding disorders
Note: Use in patients with the following conditions should be carefully considered and/or appropriately managed.
- The presence of very large stones that have previously failed lithotripsy
- Pregnancy
Warnings
When using in conjunction with a laser, carefully consider energy and power settings in accordance with the manufacturer’s instructions.
- Position and maintain the device so that the stone is visible between the black marking bands.
- The double black marking band is 12 mm from the coil. If the double black marking band becomes visible between the scope and the stone, then discontinue lasering and return to step 1.
Do not rotate the Stone Cone Coil clockwise while the device is deployed. To do so may result in entrapment of ancillary equipment (i.e. guidewires, laser fibers, or other foreign objects).
- Withdraw the coil under direct vision.
- The Stone Cone Coil is designed to capture all stones larger than 2 mm.
- Some fragments smaller than 2 mm will be released through the opening in the center of the coil.
- Watch for elongating of the coil and lightening color of the ureteral wall during sweeping. This may indicate that the coil is encountering resistance.
- If the coil elongates, stones larger than 2 mm may be released.
- If the object appears to be too large for the lumen, further fragment the stone and then attempt to withdraw the coil.
- Continue to sweep the multiple fragments until the device scope and coil reach the bladder.
- Repeat the insertion and sweeping procedures if necessary.
Precautions
- Bending the sheath greater than 180° will hinder the mechanical operation of the device.
- It is recommended that the ureter be pre-dilated before endoscopy and stone retrieval, to prevent stone impaction when extracting the stone.
- Use in patients with renal malignancy should be carefully considered.
Adverse events
Adverse events generally recognized with the use of stone retrieval devices include, but are not limited to:
- Allergic Reaction
- Edema
- Hemorrhage
- Hydronephrosis
- Infection
- Fever
- Sepsis
- Urinary Tract Infection
- Inflammation
- Laceration
- Obstruction
- Pain/discomfort
- Perforation
- Stenosis
- Stone impaction
- Stone migration
- Tissue Damage
- Unretrieved Device Fragments
- Ureteral Avulsion
- Urinary Symptoms
- Dysuria
- Urgency
- Urinary Retention
Adverse events may require additional medical or surgical intervention or prolonged procedure.