Flexima™ and Percuflex™ Drainage Catheters
Indications, Safety, and Warnings
Flexima Drainage Nephrostomy Biliary
INTENDED USE/INDICATIONS FOR USE CATHETER SYSTEM AND KIT
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
CONTRAINDICATIONS
Where percutaneous drainage catheterization is unacceptable.
WARNINGS
Do not use catheter for feeding tube/gastrostomy procedures. Exposure to gastric juices may damage the catheter.
PRECAUTIONS
Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the coating and catheter.
ADVERSE EVENTS
- Catheter Occlusion and/or Dislodgment
- Dysuria and Frequency/Urgency
- Encrustation
- Fistula
- Hemorrhage/Hematoma
- Infection/Sepsis
- Jaundice
- Pain
- Pancreatitis
- Perforation
- Peritonitis
- Pneumothorax
Percuflex-Flexima Ureteral Stent
INTENDED USE/INDICATIONS FOR USE
The Ureteral Stent is intended to provide 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
Where percutaneous drainage catheterization is unacceptable.
PRECAUTIONS
Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the catheter.
ADVERSE EVENTS
- Catheter Occlusion and/or Dislodgment
- Dysuria and Frequency/Urgency
- Encrustation
- Fistula
- Hemorrhage/Hematoma
- Infection/Sepsis
- Pain
- Perforation
- Peritonitis
- Pneumothorax
PI-343082-AA SEP2015
vanSonnenberg Sump Catheter
INTENDED USE/INDICATIONS FOR USE
The vanSonnenberg Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, hematomas, seromas, urinomas, or any loculated fluid collection.
CONTRAINDICATIONS
Those abscesses or fluid collections which are phlegmonous or multilocular by CT or Ultrasound are generally not treated successfully by the percutaneous catheter technique. Echinococcus cysts should not be punctured and drained by this method.
PRECAUTIONS
Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the catheter.
ADVERSE EVENTS
- Catheter Occlusion and/or Dislodgment
- Encrustation
- Fistula
- Hemorrhage/Hematoma
- Infection/Sepsis Pain
- Perforation
- Peritonitis
- Pneumothorax
Malecot Stenting Malecot Nephrostomy
INTENDED USE/INDICATIONS FOR USE
The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintaining external access. The Stenting Malecot Nephrostomy Catheter with its extended tip is also designed for internal drainage from the ureteropelvic junction to the bladder.
CONTRAINDICATIONS
Where percutaneous drainage catheterization is unacceptable.
PRECAUTIONS
Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the catheter.
ADVERSE EVENTS
- Catheter Occlusion and/or Dislodgment
- Dysuria and Frequency/Urgency
- Encrustation
- Fistula
- Hemorrhage/Hematoma
- Infection/Sepsis
- Pain
- Perforation
- Peritonitis
- Pneumothorax
Amplatz Anchor Catheter System
INTENDED USE/INDICATIONS FOR USE
The Amplatz Anchor Catheter System is intended for use in applications of percutaneous drainage, particularly percutaneous nephrostomy, abscess or external biliary drainage.
CONTRAINDICATIONS
Where percutaneous drainage catheterization is unacceptable.
PRECAUTIONS
Do not allow alcohol to contact the catheter. Exposing the catheter to alcohol may damage the catheter.
ADVERSE EVENTS
- Catheter Occlusion and/or Dislodgment
- Dysuria and Frequency/Urgency
- Encrustation
- Fistula
- Hemorrhage/Hematoma
- Infection/Sepsis
- Jaundice
- Pain
- Pancreatitis
- Perforation
- Peritonitis
- Pneumothorax
PI-343073-AA SEP2015
AccuStick™ II Introducer System
INTENDED USE/INDICATIONS FOR USE
The AccuStick™ II Introducer System with radiopaque marker facilitates introduction and placement of a guidewire.
CONTRAINDICATIONS
None known.
PRECAUTIONS
None known.
WARNINGS
None known.
ADVERSE EVENTS
Potential risks exist for serious complications to include:
- Perforation of a vessel or viscus
- Laceration of a vessel or viscus
- Bleeding
- Wire or catheter embolism
- Extravasation
- Hematoma
- Hemothorax
- Hydrothorax
- Inflammation, necrosis or scarring
- Risks normally associated with percutaneous interventional procedures
- Pain in region
- Skin infection
- Edema
These and other complications are well documented in medical literature. Use of the AccuStick II Introducer System with radiopaque marker should be reserved by persons knowledgeable of the risks involved and qualified in the procedures.
PI-343055-AA SEP2015