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death of the patient. All procedures must be performed according to accepted aseptic
technique.
•
Select the size and quantity of Torpedo appropriate for the pathology to be treated.
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Do not expose the Torpedo to liquid prior to deployment. Exposing the Torpedo to liquid
prior to deployment may cause premature swelling of the Torpedo, which may inhibit
deployment.
•
Deliver each Torpedo within five (5) minutes of debubbling the Torpedo cartridge to
prevent premature swelling of the Torpedo, which may inhibit deployment.
•
In the event the delivery catheter becomes obstructed, do not attempt to flush the
catheter with excessive pressure as fracture and/or reflux of the Torpedo may occur
resulting in non-target embolization.
•
Only one (1) Torpedo should be delivered at a time. Delivery more than one (1) Torpedo at
a time may result in non-target embolization.
•
Patients with known allergy to contrast medium may require prophylactic treatment
prior to embolization.
•
Additional evaluations or precautions may be necessary in managing periprocedural care
for patients with conditions such as, but not limited to:
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Bleeding diathesis or hypercoagulative state
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Immunocompromise
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Embolization with Torpedo should only be performed by physicians who have received
appropriate interventional embolization training in the region to be treated.
POTENTIAL COMPLICATIONS
Vascular embolization is a high-risk procedure. Complications may occur at any time during or
after the procedure, and may include, but are not limited to, the following:
•
Paralysis resulting from non-targeted embolization or ischemic injury from adjacent
tissue edema
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Undesirable reflux or passage of the device into normal arteries adjacent to the targeted
lesion or through the lesion into other arteries or arterial beds, such as the internal
carotid artery, pulmonary, or coronary circulations
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Pulmonary embolism due to arterial venous shunting
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Ischemia at an undesirable location including ischemic stroke, ischemic infarction
(including myocardial infarction), and tissue necrosis
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Capillary bed occlusion and tissue damage
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Vessel or lesion rupture and hemorrhage
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Recanalization
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Foreign body reactions necessitating medical intervention
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Infection necessitating medical intervention
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Complications related to catheterization (e.g. hematoma at the site of entry, clot
formation at the tip of the catheter and subsequent dislodgment, and nerve and/or
circulatory injuries, which may result in leg injury)
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Allergic reaction to medications (e.g. analgesics)
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Allergic reaction to contrast media or embolic material
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Pain and/or rash, possibly delayed from the time of embolization
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Death
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Blindness, hearing loss, loss of smell, and/or paralysis
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Neurological deficits, including cranial nerve palsies
Additional information is found in the Warnings section
DEVICE PACKAGING
Package contains:
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Three (3) Torpedo cartridges
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One (1) blunt stylet to assist with loading the Torpedo into a catheter for delivery
The contents of each package have been sterilized using gamma irradiation.
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