P/N 7001-01 rev D
17 Apr 2017
4
PRECAUTIONS:
• Prolonged duration of occlusion may result in serious injury or death.
• Do not cut, trim or modify catheter or components prior to placement.
• Only physicians who are trained in vessel occlusion with compliant balloon catheters and have
training or experience with balloon catheters and invasive blood pressure monitoring should
consider using this device.
• Balloon rupture may occur under certain anatomical, procedural and/or clinical circumstances.
• Do not use the catheter for the treatment of dissections.
• Care should be taken when inflating the balloon in the vessel, particularly when inflating in calcified,
stenotic, and/or otherwise diseased vessels.
• Carefully inspect the package and catheter prior to use to verify no damage occurred during
shipment or storage. Do not use the catheter if the package or catheter is damaged as the sterility
or integrity of the device may be compromised and thus increases the risk of patient infection and
device malfunction.
• Do not use after labeled expiration date.
• If an obstruction in the vessel prevents or resists advancement of the catheter, do not force catheter
past the obstruction. Remove the catheter and use an alternative treatment.
• Do not exceed more than 10 inflation/deflation cycles of the balloon.
• The balloon is highly compliant. Inflate the balloon slowly to avoid over-inflation.
• Use of contrast media under appropriate medical imaging, i.e. conventional x-ray or fluoroscopy, may
be used to confirm balloon inflation.
• Carefully monitor the patient’s blood pressure throughout the procedure.
• Preparations should be made and a trained surgical team should be available in the event that
conversion to open surgery is required.
POTENTIAL ADVERSE EVENTS:
Possible clinical complications associated with this type of procedure include, but are not limited to,
the following:
• Vessel dissection, perforation, rupture or injury
• Occlusion at some locations may cause arrhythmia
• Paresthesia
• Contrast reactions
• Infection, hematoma and/or pain at insertion site
• Cardiac events
• Respiratory failure
• Hemorrhage
• Stroke
• Aneurysm rupture
• Renal complications
• Arterial thrombosis and/or embolism
• Paralysis
• Ischemia
• Death
RECOMMENDED ITEMS:
Each ER-REBOA™ Catheter package includes a single-use, sterile, disposable balloon catheter and a pre-
installed peel-away sheath on the catheter shaft. The peel-away sheath is used to straighten the P-tip® for
insertion into the introducer sheath.
Note:
The ER-REBOA™ Catheter is designed to be used WITHOUT a guidewire.
Note:
Length marks on the catheter shaft are measurements in centimeters from the middle of the balloon.
Materials required but not provided are:
• Introducer sheath (7 Fr minimum)
• 20-35 cc syringe (30 cc suggested)
• Inflation medium
þ
3:1 diluted contrast solution (75% sodium chloride (saline) / 25% contrast media
(recommended)), or
þ Sodium Chloride (saline)