Flexima™ and Percuflex™ Drainage Catheters

Indications, Safety, and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

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
PI-343082-AA SEP2015

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
PI-343082-AA SEP2015

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
PI-344004-AA SEP2015

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

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