Brochures

Regulatory notice and product safety data

USA

LC BeadM1 Indications

LC Bead is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs)

LC BeadM1 Cautions

  • Do not use if the vial or packaging appear damaged
  • Sterile and single use product.  Do not reuse
  • Select the size and quantity of LC Bead microspheres appropriate for the pathology to be treated
  • Ensure that LC BeadM1 is an appropriate size or the intended vasculature
  • Monitor patients carefully for signs of non-target embolization such as hypoxia or CNS changes
  • Consider upsizing LC BeadM1 if angiographic evidence of embolization does not appear quickly during delivery
  • Embolization with LC BeadM1 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 LC Bead M1 instructions for use.

LC BeadM1 Potential Complications

  • Undesirable reflux or passage of LC Bead microspheres 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
  • Pulmonary embolization
  • Ischemia at an undesirable location
  • Capillary bed saturation and tissue damage
  • Ischemic stroke or ischemic infarction
  • Vessel or lesion rupture and haemorrhage
  • Neurological deficits including cranial nerve palsies
  • Vasospasm
  • Death
  • Recanalization
  • Foreign body reactions necessitating medical intervention
  • Infection necessitating medical intervention
  • Clot formation at the tip of the catheter and subsequent dislodgement

Caution

Federal (USA) law restricts the sale of this device by or on order of a physician