Potential Adverse Events; Mri Safety Information - COOK Medical Sof-Flex Mode D'emploi

• These stents must not remain indwelling more than six (6) months. If the patient's status permits, the stent may be
replaced with a new stent.
• The tether should be removed if the stent is to remain indwelling longer than 14 days.
• These stents are not intended as permanent indwelling devices.
• Do not force components during removal or replacement. If resistance is encountered, stop. Determine the cause
of the resistance before proceeding.
• A pregnant patient must be more closely monitored for possible stent encrustation due to calcium supplements.
• Improper handling can seriously weaken the stent. Acute bending or overstressing during placement may result
in subsequent separation of the stent at the point of stress after a prolonged indwelling period. Angulation of the
wire guide or stent should be avoided.
• Individual variations of interaction between stents and the urinary system are unpredictable.
• Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested. The stent must be replaced if
encrustation hampers drainage.
• The potential effects of phthalates on children or pregnant or nursing women have not been fully characterized
and there may be concern for reproductive and developmental effects.
• Hydrophilically coated wires are very slippery when wet. Always maintain control of the wire guide when
manipulating it through any device.
• The patients should be instructed in terms that they understand to inform the physician if they are experiencing
any pain, cloudy urine, bladder irritation or any sign or symptoms that they are having difficulty with urination.
• If the stent is placed in a child the parents should be given these instructions.

POTENTIAL ADVERSE EVENTS

• Extravasation
• Occlusion
• Migration
• Hemorrhage
• Sepsis
• Perforation of the urinary tract
• Peritonitis
• Encrustation
• Urinary tract infection
• Loss of renal function

MRI SAFETY INFORMATION

Nonclinical testing has demonstrated that the Sof-Flex Multi-Length Ureteral Stents are MR Conditional according to
ASTM F2503. A patient with this device can be safely scanned after placement under the following conditions.
• Static magnetic field of 3.0 Tesla or 1.5 Tesla only
• Maximum magnetic field spatial gradient of 1900 gauss/cm (19.0 T/m) or less
• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of < 4.0 W/kg (Normal
Operating or First Operating Mode)
Nonclinical testing demonstrated that the Sof-Flex Multi-Length Ureteral Stents are not expected to induce RF
heating greater than that of biological tissue.
The image artifact extends approximately 6.8 mm from the Sof-Flex Multi-Length Ureteral Stents found during
nonclinical testing when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.
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