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Idiomas disponibles
Gastric distention with retained food and fluid due to
•
severely delayed gastric emptying with or without outlet
obstruction from displacement of the IGB into the
antrum.
Injury to the digestive tract during placement of the IGB
•
in an improper location such as in the esophagus or
duodenum. This could cause bleeding and perforation,
which could require a surgical or endoscopic correction
for control.
Insufficient or no weight loss.
•
Adverse health
•
weight loss.
Gastric discomfort, feelings of nausea and vomiting
•
following IGB placement as the digestive system
adjusts to the presence of the IGB.
Continuing nausea and vomiting. This could result from
•
direct irritation of the lining of the stomach, delayed
gastric emptying and/or the IGB blocking the outlet of
the stomach. It is even theoretically possible that the
IGB could prevent vomiting (not nausea or retching) by
blocking the inlet to the stomach from the esophagus.
•
A feeling of heaviness in the abdomen.
Abdominal or back pain, either steady or cyclic.
•
•
Gastroesophageal reflux.
Influence on digestion of food.
•
Blockage of food entering into the stomach.
•
Bacterial growth in the fluid which fills the IGB. Rapid
•
release of this fluid into the intestine could cause
infection, fever, cramps and diarrhea.
•
Injury to the lining of the digestive tract as a result of
direct contact with the endoscope, the IGB, grasping
forceps, or as a result of increased acid production by
the stomach. This could lead to ulcer formation with
pain, bleeding or even perforation. Surgery could be
necessary to correct this condition.
IGB
deflation
•
replacement.
•
Acute pancreatitis.
•
Spontaneous hyperinflation due to gas production
within the IGB.
10.2
POSSIBLE
COMPLICATIONS
ENDOSCOPY & SEDATION
Potential
risks
associated
procedures include, but are not limited to: abdominal
cramping and discomfort if air is used to distend the
stomach, sore or irritated throat, bleeding, infection, tearing
of the esophagus or stomach that could lead to perforation,
and aspiration pneumonia. The risk increases if additional
procedures are performed.
According to the American College of Gastroenterology,
risks related to sedation during endoscopic procedures are
rare, occurring in less than one in every 10,000 people.
most common complications involve a temporary decrease
in the rate of breathing or heart rate, which can be corrected
by giving extra oxygen or by reversing the effect of the
sedative medications. Patients with heart, lung, kidney, liver,
or other chronic diseases are at higher risk for
complications. Drug dosages and airway management
consequences
resulting
(i.e.
collapse)
and
subsequent
OF
ROUTINE
with
upper
endoscopic
should be taken into consideration when treating high risk
patients.
11.
HOW SUPPLIED
Each IGB System contains an IGB positioned within a
"Placement Catheter Assembly" and a "Fill Kit". All are
supplied NONSTERILE and FOR SINGLE USE ONLY. All
components should be handled carefully.
Materials Included:
•
One (1) Intragastric Balloon (IGB) System consisting of:
from
o One (1) Placement Catheter Assembly (i.e. Sheath
Assembly) containing the IGB
o One (1) Fill Kit with IV Spike
Materials Not Included:
•
Endoscope
Surgical Gel
•
•
Sterile Saline
Sterile 50cc Syringe
•
Removal tools (i.e. sheathed needle catheter, long jaw
•
or wire prong grasper)
11.1
CLEANING INSTRUCTIONS
In the event that the product becomes contaminated prior to
use, it should not be used but should be returned to the
manufacturer.
CAUTION: DO NOT SOAK THE PRODUCT IN A
DISINFECTANT because the silicone elastomer may
absorb some of the solution which could subsequently leach
out and cause tissue reaction.
11.2
DISPOSAL
Dispose of any used or explanted device's or device
components in accordance with any local regulations for
medical waste.
12.
DIRECTIONS FOR USE
The IGB is supplied positioned within the Placement
Catheter Assembly. Inspect the package seal and the
Placement Catheter Assembly for damage prior to use. It
should not be used if any damage is noted. A back-up IGB
should be available at the time of placement.
DO NOT REMOVE THE IGB FROM THE PLACEMENT
CATHETER ASSEMBLY.
A Fill Kit is provided to assist with the IGB deployment.
CAUTION: If the IGB becomes separated from the catheter
or sheath prior to placement, do not attempt to use the IGB
or reinsert the IGB into the sheath.
12.1
IGB PLACEMENT AND FILLING
1
The
Prepare the patient for endoscopy. Inspect the esophagus
and stomach endoscopically and then remove the
endoscope. If there are no contraindications, insert the
Placement Catheter Assembly containing the IGB gently
down the esophagus and confirm that it is below the lower
esophageal sphincter and well within the stomach cavity
before removing the guidewire and proceeding. The small
size of the Placement Catheter Assembly allows ample
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