IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
29
European User Manual
emboli, Loss of speech (temporary aphasia from laryngeal nerve damage), arm paresis,
burn, hemorrhage, pneumonitis.
•
Severe
adverse events: respiratory failure/arrest, pneumothorax, hemothorax, pleural
effusion, pneumonia, empyema, lung collapse, thrombosis, phrenic nerve palsy,
subcutaneous emphysema, death due to Acute respiratory distress syndrome, pulmonary
emboli, prolonged chest tube drainage, prolonged intubation pulmonary
insufficiency/failure, hemorrhage, dyspnea, atelectasis.
Liver
•
Mild/moderate
adverse events: changes in the laboratory parameters-elevation in AST
(Aspartate Aminotransferase) and/ or ALN (Alanine aminotransferase) level
–
reflects
hepatocellular damage of normal liver parenchyma, minimal self-limited serum bilirubin
level elevation, hematoma, hemorrhage, nyoglobinemia, pleural effusion, hemothorax,
pneumothorax, thrombosis.
•
Severe
adverse events: Severe changes in the laboratory parameters-elevation in AST
(aspartate aminotransferase) and/ or ALN (Alanine aminotransferase) level - reflects
hepatocellular damage of normal liver parenchyma, life threatening serum bilirubin level
elevation, hemorrhage, cryoshock (hypotension, respiratory compromise, multi organ
failure, DIC), post procedural abscess- due to conduit ascending bacterial (especially in
patients with history of biliary interventions and biliary enteric anastomosis ), pleural
effusion, hemothorax, pneumothorax, thrombosis of the portal vein branches.
Musculoskeletal:
•
Mild/moderate
adverse events: muscular injury, pain, swelling, osteonecrosis,
osteomyelitis, chondrolysis, nerve palsy, motor dysfunction, peri-ablational neuropathies.
•
Severe
adverse events: compartment syndrome osteonecrosis, osteomyelitis,
chondrolysis, nerve palsy, motor dysfunction, peri-ablational neuropathies, bowel
damage, urinary tract damage, pericardial effusion in (in chest wall ablations), avascular
necrosis of femur head, ureteral stricture.
Gynecology:
Mild/ moderate
adverse events: spotting, urinary tract infection, treatment site infection, uterine
bleeding, genitourinary perforation, pelvic pain.
Dermatology:
Mild/ moderate
adverse events: skin burn/frostbite, wound complication and wound infection.
