Potential Adverse Events - COOK Medical Universa Gebrauchsanweisung

POTENTIAL ADVERSE EVENTS

Complications of ureteral stent placement are documented. These complications include, but are not limited to:
• Extravasations
• Occlusion
• Migration
• Hemorrhage
• Sepsis
• Perforation of the urinary tract
• Peritonitis
• Encrustation
• Urinary tract infection
• Loss of renal function.
PRODUCT RECOMMENDATIONS
If no wire guide is provided with this set, the following is recommended:
• 5.0 French stents accept .035"
• 6.0 French stents accept .038"
• 7.0 French stents accept .038"
• 8.0 French stents accept .038"
MRI SAFETY INFORMATION
Nonclinical testing has demonstrated that the Universa Ureteral Firm Stents are MR Conditional according to ASTM
F2503. A patient with this device may be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 tesla or 3.0 tesla only
• Maximum spatial gradient magnetic field of 1600 gauss/cm (16.0 T/m) 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 continuous scanning
Under the scan conditions defined above, Universa Firm Ureteral Stents are expected to produce a maximum
temperature rise of 1.6°C after 15 minutes of continuous scanning.
The image artifact extends approximately 7 mm for the Universa Firm Ureteral Stents as found during nonclinical
testing when imaged with a gradient echo pulse sequence and a 3.0 tesla MR system. The image artifact obscures the
device lumen.
INSTRUCTIONS FOR USE
Endoscopic Placement
NOTE: Prior to use, immerse stent in sterile water or isotonic saline to allow the hydrophilic surface to absorb water
and become lubricious. This will ease placement under standard conditions.
1. Pass a flexible wire guide tip to the renal pelvis.
2. Using a baseline pyelogram, estimate the proper stent length; add 1 cm to that estimated ureteral measurement.
Accurate measurement enhances drainage efficiency and patient comfort.
3. Pass the stent over the wire guide through the cystoscope. Under direct vision, advance the stent into the ureter
with the stent positioner. Have an assistant hold the wire guide in position to prevent advancement of the wire
guide into the renal parenchyma.
4. Watch for the distal ink band of the stent to appear at the ureterovesical junction. At that point, halt
advancement of the stent.
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