Expel™ Drainage Catheter

CONTRAINDICATIONS

The drainage catheter is contraindicated where percutaneous drainage catheterization is unacceptable.

Do not use catheter for feeding tube/gastrostomy procedures. Exposure to gastric fluids will damage the catheter.

Do not use catheter within the bilio-pancreatic system. Exposure to biliary fluids will damage the catheter.

Additionally for Expel™ Large Capacity: 

The drainage catheter is contraindicated where large diameter (≥ 16F) percutaneous drainage catheterization is unacceptable.

WARNINGS

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

PRECAUTIONS

These recommendations are meant to serve only as a basic guide to the use of this catheter. Percutaneous drainage should not be undertaken without comprehensive knowledge of the indications, techniques, and risks of the procedure.

Expel™ Large Capacity Drainage Catheter

• Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days. This catheter should be evaluated by the physician on or before 90 days post-placement.  
• Catheters attached to suction should follow normal clinical practices in selecting a static vacuum level. Testing has demonstrated the catheters can withstand a negative pressure of 200 mmHg (26.7 kPa).
  

Expel™ Drainage Catheter with Twist-Loc™ Hub and Expel Drainage Catheter

• Where long-term use is indicated, it is recommended that indwelling time not exceed the following limits, and that the physician evaluate the catheter before this time has elapsed.
  • 90 days, for Expel MPD and MPDL Draining Catheter and Kit;
  • 30 days, for Expel Nephrostomy Drainage Catheter and Kit. 
• Catheters attached to suction should follow normal clinical practices in selecting a static vacuum level. Testing has demonstrated the catheters can withstand a negative pressure of 200 mmHg (26.7 kPa). 

ADVERSE EVENTS

The complications that may result from the use of these devices include, but are not limited to:

• Catheter Occlusion and/or Dislodgment
• Encrustation
• Fistula
• Hemorrhage/Hematoma
• Infection/Sepsis
• Pain
• Perforation
• Peritonitis
• Pneumothorax

Additional Adverse Event for Expel™ MPD™ and MPDL Drainage Catheter and Kit, Expel Nephrostomy:

• Dysuria and Frequency/Urgency 

INTENDED USE / INDICATIONS FOR USE

The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.

The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

CONTRAINDICATIONS

The Expel Nephroureteral Stents and Expel Ureteral Stent System are contraindicated where percutaneous drainage catheterization is unacceptable. 

WARNINGS

• Do not use the stent for feeding tube/gastrostomy procedures. Exposure to gastric fluids may damage the stent.

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

PRECAUTIONS

These recommendations are meant to serve only as a basic guide to the use of this stent. The performance of urinary collections and percutaneous placement of ureteral stents should not be undertaken without comprehensive knowledge of the indications, techniques, and risks of the procedure.

• Where long-term use is indicated it is recommended that the indwelling time of the stent does not exceed 30 days. This stent should be evaluated by the physician on or before the 30 days post-placement. 
  
• Testing has demonstrated the Nephroureteral stent can withstand a negative pressure of 200 mmHg (26.7 kPa).
  

Magnetic Resonance Imaging (MRI) Safety Information

Magnetic Resonance Conditional

Non-clinical testing has demonstrated that Expel Nephroureteral Stents are MR Conditional according to ASTM F2503.
A patient with these devices can be safely scanned in an MR system meeting the following conditions:

• Static magnetic field of 1.5 tesla and 3 tesla only
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m) or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the Expel Nephroureteral Stents are expected to produce a maximum temperature rise of 4.0 °C (single device configuration) after 15 minutes of continuous MR scanning.
Maximum whole body averaged (WBA) specific absorption rate (SAR) of: 

• 2.0 W/kg at 1.5 Tesla (local SAR < 5.8 W/kg), single device configuration
• 2.0 W/kg at 3 Tesla (local SAR < 6.5 W/kg), single device configuration
• For 15 minutes of continuous MR scanning.

1.5 Tesla Temperature Information
In non-clinical testing, the Expel Ureteral Stents produced a temperature rise of less than 1.4 °C at a maximum extrapolated WBA SAR of 2.0 W/kg for 15 minutes of continuous MR scanning with body coil in a 1.5 Tesla MR RF coil.

3 Tesla Temperature Information
In non-clinical testing, the Expel Ureteral Stents produced a temperature rise of less than 4.0 °C at a maximum extrapolated WBA SAR of 2.0 W/kg for 15 minutes of continuous MR scanning with body coil in a 3 Tesla MR RF coil. 

Image Artifact Information
MR Imaging quality may be compromised if the area of interest is in exactly the same area or relatively close to the position of the catheter.

ADVERSE EVENTS

The complications that may result from the use of these devices include, but are not limited to:

• Stent Occlusion and/or Dislodgment
• Dysuria and Frequency/Urgency
• Encrustation
• Fistula
• Hemorrhage/Hematoma
• Infection/Sepsis
• Pain
• Perforation
• Peritonitis
• Pneumothorax