Flexima™ and Percuflex™ Drainage Catheters

Drainage Catheter System and Kit: To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.

Biliary Catheter System and Kit: To provide external and internal percutaneous drainage of the biliary system.

Nephrostomy Catheter System and Kit: To provide external drainage of the urinary tract.

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.

These recommendations are meant to serve only as a basic guide to the utilization of this catheter. The performance of percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections should not be undertaken without comprehensive knowledge of the indications, techniques, and risks of the procedure.

Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the coating and catheter.

For units with Glidex™ Hydrogel Coating:

• Caution: Do not attempt to remove catheter prior to unlocking pigtail.

• Do not wipe catheter with dry gauze or any solvents as it may damage coating.

• Keep the catheter wet during placement.

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 mm Hg (26.7 kPa).

These recommendations are meant to serve only as a basic guide to the utilization of this catheter. The performance of nephrostomy and urinary collections should not be undertaken without comprehensive knowledge of the indications, techniques and risks of the procedure.

• Caution: Do not attempt to remove catheter prior to unlocking pigtail.

• Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the catheter.

• Where long-term use is indicated it is recommended that the indwelling time of the catheter does not exceed 90 days. This catheter should be evaluated by the physician on or before the 90 days post-placement.

• Testing has demonstrated the catheters can withstand a negative pressure of 200 mmHg (26.7 kPa).

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

• Caution: Prior to inserting the ureteral stent, make certain the suture is not wrapped around the stent. If the suture becomes wrapped around the stent and pulled it could sever the device.

• Caution: If suture cannot easily be removed, it is recommended that an additional 20 cm of suture be attached to one end of the cut suture. Advance a 6F dilator over suture to ureteral stent. The 6F dilator will maintain stent position while slowly removing the suture from the stent.

• Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the catheter.

For units with Glidex™ Hydrogel Coating:

• Do not wipe catheter with dry gauze or any solvents as it may damage coating.

• Keep the catheter wet during placement.

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.

• Catheter Occlusion and/or Dislodgment

• Dysuria and Frequency/Urgency

• Encrustation

• Fistula

• Hemorrhage/Hematoma

• Infection/Sepsis

• Pain

• Perforation

• Peritonitis

• Pneumothorax

Additional ADVERSE EVENTS specific to Flex-VTC-Sacks-APDL-vSon Catheters:

• Jaundice

• Pancreatitis