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Xcela® Power Injectable Ports

Indications For Use

Indications: The Xcela® Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. 

When used with a power injectable needle, the Xcela® Power Injectable Port is indicated for power injection of contrast media. for power injection of contrast media, the maximum recommended infusion rate is 5ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Absolute Contraindications:

This device is not designed, sold or intended for use except as indicated. The port system must not be used in case of:

  • inadequate body tissue to support the device
  • bacteraemia
  • sepsis
  • known or suspected allergic response to the materials
  • severe chronic obstructive lung disease exists
  • past irradiation of prospective insertion site
  • previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site
  • local tissue factors will prevent proper device stabilization and/or access

Possible Complications

The use of a subcutaneous port provides an important means of venous access for critically ill patients; however, the potential exists for serious complications including the following:

  • air embolism
  • bleeding
  • brachial plexus injury
  • cardiac arrhythmia
  • cardiac tamponade
  • catheter or port-related sepsis
  • catheter or port erosion through the skin
  • catheter occlusion, damage or breakage due to compression between the clavicle and first rib
  • device rotation or extrusion
  • endocarditis
  • extravasation
  • fibrin sheath formation
  • hematoma
  • hemothorax
  • hydrothorax
  • intolerance reaction to implanted device
  • inflammation, necrosis, or scarring of skin over implant area
  • laceration of vessels or viscus
  • pneumothorax
  • spontaneous catheter tip malposition or retraction
  • thoracic duct injury
  • thromboembolism
  • vascular thrombosis
  • vessel erosion
  • risks normally associated with local and general anesthesia, surgery, and post-operative recovery


These and other complications are well documented in medical literature and should carefully be considered before placing the port. 

Suggested Instructions for Use/Plant Implantation

Sterile conditions must be maintained during the implantation procedure. 

Sterility

Uncompromising sterility and strictly aseptic conditions must be maintained, i.e.:

  • disinfection of hands
  • when required, shaving of the incision area
  • disinfection of the implantation site
  • sterile swaps, drapes, gloves and sterile covering for any procedure
  • sterile products


I. Prior to beginning placement procedure, do the following:

  • Examine package carefully before opening to confirm its integrity and that the expiration date has not passed. The device is supplied in a double sterile package and is not-pyrogenic. Do not use if package is damaged open or the expiration date has passed. Sterilized by ethylene oxide. Do not re-sterilize. 
  • Inspect kit for inclusion of all components
  • Prime the device with sterile heparinized saline or normal saline solution to help avoid air embolism. 
  • When using an introducer kit, verify that the catheter fits easily through the introducer sheath. 


II. To avert device damage and/or patient injury during placement:

  • Avoid accidental device contact with sharp instrument and mechanical damage to the catheter material. use only smooth-edged atraumatic clamps or forceps. 
  • Avoid perforating, tearing or fracturing the catheter when using a guidewire. 
  • Do not use the catheter if there is any evidence of mechanical damage or leaking. 
  • Avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen(s).
  • Carefully follow the connection technique given in these instructions to insure proper catheter connection and to avoid catheter damage. 
  • If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter. 


When using percutaneous introducers:

  • Carefully insert the introducer over the guidewire to avoid inadvertent penetration to vital structures in the thorax.
  • To avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel without the internal support of a catheter or dilator. 
  • Simultaneously advance the sheath and dilator with rotational motion to help prevent sheath damage. 

Cautions

  • If the sutures are used to secure the catheter make sure they do not occlude or cut the catheter.
  • Prior to advancing the click connector, ensure that the catheter is properly positioned. A catheter not advanced to the proper region may not seat securely and lead to dislodgement and extravasation. The catheter must be straight with no sign of kinking. A slight pull on the catheter is sufficient to straighten it. Advancing the click connector over a kinked catheter may damage the catheter.
  • Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler. 

Warnings

  • Avoid vessel perforation.
  • Failure to warm contrast media to body temperature may result in Xcela® Power Injectable Port failure.
  • Failure to ensure free solution passage of the catheter may result in Xcela® Power Injectable Port failure.
  • Exceeding the maximum flow rate may result in Xcela® Power Injectable Port failure.
  • If local pain, swelling or signs of extravasation are noted, the injection should be stopped immediately.
  • A power injectable needle must always be used to access the Xcela® Power Injectable Port.
  • Failure to ensure patency of the catheter may prior to power injection studies may result in port system failure.
  • Do not exceed 300 psi pressure limit setting, or the maximum flow rate setting shown.
  • Intended for single patient use. Do not reuse.
  • The Xcela® Power Injectable Port is a single use device and should never be reimplanted. Reuse carries with it the attendant concern of cross-infection regardless of the cleaning or sterilization method. Resterilization of incompletely cleaned devices may not be effective. Any device that has been contaminated by blood should not be reused or sterilized.
  • After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
  • Pinch-Off Prevention: Catheters placed percutaneously or through a cut down into the subclavian vein should be inserted at the junction of the outer and middle thirds of the clavicle, lateral to the thoracic outlet. The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and the clavicle, which can cause damage and even severance of the catheter. A radiographic confirmation of catheter placement should be made to ensure that the catheter is not being pinched by the first rib and clavicle.
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Xcela® Power Injectable Ports