Indications
Silicone Hydro-Coated Double Loop Ureteral Stents are intended for:
Drainage of the upper urinary tract over fistulas or ureteral obstacles. Healing of the Ureter

Contraindications
Untreated progressive infection of the upper urinary tract. The evaluation of the allergic background of a patient is the healthcare professional’s responsibility. Do not attempt stent placement in a patient with suspect ureteral avulsion. Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions
These kits must only be used by trained and experienced physicians. Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.

Potential Complications
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: Migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.

Advice to the Patient
The physician must inform the patient of the risks associated with the use of the device.

The risks and benefits of using Imajin® Silicone Hydro-Coated Double Loop Ureteral Stent Kit should be considered in patients.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
February 21, 2023
PM 15976

Indications
Biosoft duo Double Loop Ureteral Stents can be used for:
Drainage of the upper urinary tract over fistulas or ureteral obstacle.
Healing of the Ureter.

Target population are Patients requiring ureteral stenting for drainage and/or healing of the ureter.
Duration of Use: Biosoft duo Double Loop Ureteral Stent may remain implanted for up to 6 months.

Contraindications
Untreated progressive infection of the upper urinary tract.
These devices may particularly contain traces of silicone resulting from the manufacturing process. The evaluation of the allergic background of a patient is the health care professional’s responsibility.
Do not attempt stent placement in a patient with suspect ureteral avulsion.
Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions
These kits must only be used by trained and experienced physicians.
Reuse of this single use product may create a potential risk to the user.
Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.
If the stent is intended to remain implanted for more than seven days, remove the withdrawal thread prior to implantation.

Potential Complications
The following events have been reported although their occurrence greatly depends on patients’ medical
conditions.

Adverse events include but are not limited to: migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion, and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.

The risks and benefits of using Biosoft Duo Double Loop Ureteral Stent Kit should be considered in patients

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
12/07/2021
PM-19611

Indications
Vortek Double Loop Ureteral Stents are intended for:
Drainage of the upper urinary tract over fistulas or ureteral obstacles.
Healing of the Ureter.

Contraindications
Untreated progressive infection of the upper urinary tract.
These devices may particularly contain traces of silicone resulting from the manufacturing process; the evaluation of the allergic background of a patient is the health care professional’s responsibility.
Do not attempt stent placement in a patient with suspect ureteral avulsion.
Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions
These kits must only be used by trained and experienced physicians.
Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient.
Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.

Potential Complications
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion, and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.

Advice to the Patient
The physician should educate the patients on their implanted stent and the need for regular monitoring.
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.

The risks and benefits of using Vortek Double Loop Ureteral Stent Kits should be considered in patients.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
12/10/2021
PM-19678

Indications
The Vortek^® Hydro-coated Ureteral Stent is intended for:
Drainage of the upper urinary tract over fistulas or ureteral obstacles.
Healing of the Ureter.

Contraindications
Untreated progressive infection of the upper urinary tract. These devices may particularly contain traces of silicone resulting from the manufacturing process; the evaluation of the allergic background of a patient is the health care professional’s responsibility. Do not attempt stent placement in a patient with suspect ureteral avulsion. Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions
Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient. Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them. If the stent is intended to remain implanted for more than seven days, remove the withdrawal thread prior to implantation.

Adverse Events
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion, and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.

The risks and benefits of using Vortek^® Hydro Double Loop Ureteral Stent Kits should be considered in patients.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Minneapolis, MN
11/16/2021
PM-19369