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Aspira® Drainage Catheter
I N S T R U C T I O N S F O R U S E
PRODUCT DESCRIPTION
The Aspira® Drainage Catheter is a tunneled, long-term catheter used to drain
accumulated fluid from the pleural or peritoneal cavity to relieve symptoms
associated with pleural effusion or malignant ascites. The catheter is implanted
in the patient's pleural or peritoneal cavity enabling the patient to perform
intermittent drainage at home. Drainage is achieved using the Aspira Drainage
System.
The primary components of the system are the Aspira Drainage Catheter and the
Aspira Drainage Kit. The proximal end of the catheter has a valve that prevents
fluid or air from moving in or out of the pleural space or peritoneal cavity until the
valve is activated. The valve can be activated by the approved Aspira Drainage
Bag or by connecting the catheter to wall suction unit, water seal drainage
system, glass vacuum bottle, syringe or other appropriate method using the Luer
Adapter or Universal Tubing Adapter.
The drainage catheter provides patients with a convenient and compassionate
way to relieve pleural effusion or malignant ascites symptoms at home.
INDICATIONS FOR USE
The Aspira Drainage System is indicated for intermittent drainage of recurrent
and symptomatic pleural effusions or malignant ascites. The catheter is intended
for long-term access of the pleural or peritoneal cavity in order to relieve
symptoms such as dyspnea and chest discomfort associated with malignant
pleural effusions and other recurrent effusions.
CONTRAINDICATIONS
This device is contraindicated under the following conditions:
Known or suspected pleural or peritoneal cavity infection or sepsis.
Known or suspected coagulopathy or other hemorrhagic tendency.
Pleural or peritoneal cavity fluid is multi-loculated in a way that drainage from a
single location is not expected to effectively relieve related symptoms.
Patient medical condition including their anatomy is insufficient to
accommodate an indwelling drainage catheter.
Dyspnea developed by other medical conditions is irrelevant to the pleural
effusion.
Patient is known or suspected to be allergic to materials contained in the device.
Patient has a medical history of symptom palliation failure by drainage.
WARNINGS
For single patient 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.
Do not use excessive force on the valve or catheter. Excessive force or incorrect
usage may damage the device, or cause accidental catheter dislodgement.
Do not access the catheter valve with anything other than Aspira Drainage
System approved devices
Accessing the catheter valve with anything other than Aspira Drainage System
approved devices may damage the valve.
Dispose of the used product in accordance with accepted medical practice and
applicable local, state and federal regulations. Used product may present a
potential biohazard.
When using the Luer Adapter or Universal Tubing Adapter to access the
catheter, attach the adapter to the syringe or wall suction line prior to
attachment to the catheter.
The Luer Adapter and Universal Tubing Adapter create an open pathway into or
out of the catheter; to close the pathway when not in use, tighten the pinch
clamp.
Do not attempt to pass a guide wire, needle or other device through the valve.
Do not flush or attempt to clear an occluded catheter with a syringe smaller than
10 mL.
PRECAUTIONS
English
Caution - Federal Law (USA) restricts this device to sale by or on the order
of a physician.
Insertion or removal of this device is only to be done by qualified health
professionals.
Follow aseptic techniques when inserting the catheter.
If the guide wire must be withdrawn while the needle is inserted, remove both
the needle and guide wire as a unit to prevent the needle from damaging or
shearing the guide wire.
Sutures should not be tied around the catheter itself. The provided suture wing
will secure the catheter without compromising catheter patency.
Use only the Luer Adapter or Universal Tubing Adapter to access the catheter
with a syringe, wall suction unit, water seal drainage system or glass vacuum
bottle per instructions below.
Avoid puncturing or lacerating the liver, bowel or any abdominal organs with the
introducer needle.
PRIOR TO PLACEMENT
Inspect kit to ensure all components are included.
Use only the Luer Adapter or the Universal Tubing Adapter to access the catheter
with a syringe or wall suction per instructions below.
DURING PLACEMENT
Do not allow the device to contact sharp instruments. Mechanical damage may
occur. Use only smooth edged atraumatic clamps or forceps.
Care must be taken to avoid puncturing and damaging the lung, peritoneal wall
and other organs.
Do not use the catheter if it is damaged.
Carefully follow the catheter valve connection technique described in the
instructions to ensure proper connection and avoid catheter damage.
If the guide wire must be withdrawn while the needle is inserted, remove both
the needle and guide wire as a unit to prevent the needle from damaging or
shearing the guide wire.
AFTER PLACEMENT
Do not use the catheter if it is damaged.
Do not attempt to repair the catheter if damage has occurred within 5 cm of the
exit site.
Do not access the catheter with anything other than Aspira Drainage System
approved devices.
Be careful not to dislodge the catheter when assembling the valve.
POTENTIAL COMPLICATIONS
Inserting the catheter and draining the fluid may result in any of the following
complications:
Abdominal wall cellulitis
Accidental catheter dislodgement,
breakage or removal
Bowel damage
Catheter malposition
Catheter or cuff erosion through skin
Electrolyte imbalance
Empyema
Exposure to bodily fluids
Hematoma
Hemoperitoneum
Hemothorax
Hypotension subsequent to drainage
INSERTION INSTRUCTIONS
Before beginning this procedure, read the "Contraindications", "Warnings",
"Precautions" and "Potential Complications" sections of this manual.
Possible placement techniques are: antegrade, retrograde and over-the-wire.
The following are common steps that apply to all three placement techniques
listed above.
COMMON STEPS
1. Select the site for catheter insertion.
2. Create sterile field and open tray. Surgically prep and drape the operative site.
3. Perform adequate anesthesia.
4. Flush catheter through Y-connector to hydrate stylet. Allow catheter to soak
in saline. (fig. 1a)
5. Attach the introducer needle to the syringe. (fig. 1b)
6. Insert the introducer needle into the pleural space or peritoneal cavity and
aspirate fluid to confirm proper positioning. (fig. 1b)
Infection
Leakage
Loculation of peritoneal cavity
Occlusion
Pain during fluid removal
Peritonitis
Pneumothorax
Protein depletion
Re-expansion pulmonary edema
Sepsis
Skin irritation or infection
Splenic or hepatic laceration
Tumor seeding
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