Taewoong Uventa Urethral Stent Manual Del Usuario página 4

 Uventa
TM
Urethral Stent can be repositioned immediately after deployment.
 Caution should be exercised not to move the position of the Stent when checking
the position of the Stent with cystoscope after surgery
 Sexual activity should be prohibited while Stent is installed.
 When selecting the position of the Stent, be careful not to install the Stent in the
external sphincter.
 Patients who use erection assistant devices or are prescribed injections for erectile
dysfunction should not use the Stent.
 Patients who were implanted with artificial urinary sphincter should not use the
Stent.
 Do not attempt to recapture/reload a stent once its deployment is advanced.
6. Precautions
Read the entire User's Manual thoroughly before using this device. It should only be
used by or under the supervision of physicians thoroughly trained in the placement of
Stents. A thorough understanding of the techniques, principles, clinical applications and
risks associated with this procedure is necessary before using the device.
 Care should be taken when removing the introducer system and guidewire
immediately after Stent deployment since this may result in Stent dislodgement if
the Stent has not been adequately deployed.
 Care should be taken when performing dilation after the Stent has been deployed
as this may result in perforation, bleeding, Stent dislodgement or Stent migration.
 Expiration date indicated on the packing should be checked and the use of the
product which had gone beyond its expiration date is prohibited.
 If the packaging is open or damaged, you cannot use it as Uventa
Stent is supplied sterilized.
 This product is disposable medical equipment. Reuse of it after resterilization is
prohibited.
7. Instructions for Damages
WARNING: Visually inspect the system for any sign of damage. DO NOT USE the
system if any visible signs of damage are present. Failure to observe this precaution
may result in patient injury.
8. Potential complications
Potential complications associated with the use of Uventa
but is not limited to:
Procedural Complications
 Bleeding
 Pain
 Stent misplacement
 Inadequate expansion of Stent
 Urethral perforation
Post Stent Placement Complications
 Bleeding
 Pain
 Urethral fistula or perforation
 Incontinence
 Stent misplacement or migration
 Stent occlusion due to encrustation
 Stent occlusion due to tissue ingrowth
 Stent occlusion due to tissue overgrowth or hyperplasia
 Fever
 Foreign body sensation
 Sepsis
 Infection
 Tissue erosion around urethra due to Stent stimulation
9. Required equipments
- Urethroscope or Cystoscope (over 10Fr. Working Channel)
- Sizing catheter
- Fluoroscope / C-Arm (if necessary)
- Forceps (if necessary)
- 0.035" / 0.89 mm Guide wire
10. Procedure
① Examine Stricture
a) Carefully examine both proximal and distal segment of stricture by endoscopy
and/or fluoroscopy.
b) The internal luminal diameter should be measured accurately with endoscope
and/or fluoroscope.
② Determine Stent Size
a) Measure the length of target stricture.
b) Select a Stent size that is longer than the measured length of target stricture in
order to fully cover both ends of the lesion (more than 5mm in the direction of the
sphincter, more than 10mm in the direction of the external urethral orifice).
③ Stent Deployment Preparation
TM
- Uventa Urethral Stent can be placed with the aid of fluoroscopy and/or
endoscopy.
- Pass a 0.035" (0.89 mm) guide wire to the region of the stricture.
TM
Urethral
TM
Urethral Stent may include,