USA
Bead Block is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)
Bead Block Cautions:
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Do not use if the syringe or packaging appear damaged
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Sterile and single use product. Do not reuse
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Select the size and quantity of Bead Block microspheres appropriate for the pathology to be treated
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Embolization with Bead Block microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized
For instructions for use, please refer to www.biocompatibles.com/beadblock-ifu
Bead Block Potential Complications:
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Undesirable reflux or passage of Bead Block 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 embolization
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Ischemia at an undesirable location
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Capillary bed saturation and tissue damage
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Ischemic stroke or ischemic infarction
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Vessel or lesion rupture and haemorrhage
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Neurological deficits including cranial nerve palsies
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Vasospasm
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Death
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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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Clot formation at the tip of the catheter and subsequent dislodgement