IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
27
European User Manual
Severe
adverse events: infection, thermal injury, procedure done on the wrong patient/
part of the body, retention of foreign object after surgery, pulmonary emboli, congestive
heart failure, stroke, fall, severe changes in the laboratory parameters-elevation in
aspartate aminotransferase and/ or alanine aminotransferase (this reflects hepatocellular
damage), life threatening serum bilirubin level elevation, perirenal fluid collection,
hemorrhage, cryoshock (hypotension), respiratory compromise, multi organ failure,
disseminated intravascular coagulation (DIC), abscess, pleural effusion, hemothorax,
pneumothorax, thrombosis of the portal vein branches, allergic/anaphylactoid reaction,
angina/coronary ischemia, myocardial infarction, arrhythmia, atelectasis, adjacent organ
injury.
Anesthesia
•
Mild/moderate
adverse events: hypoxia, hypotension -low blood pressure, cough,
residual neuromuscular block in recovery, intubation complications, slow to regain
consciousness, anesthetic turn off too early.
•
Severe
adverse events: hypoxia, hypotension
–
low blood pressure, residual
neuromuscular block in recovery.
Cryoablation procedure in general
•
Mild/moderate
adverse events: hematoma, hemorrhage, infection, pain, fever, thermal
injury, thrombocytopenia, coagulation dysfunction.
•
Severe
adverse events: haemorrhage, infection, tumor seeding, thermal injury,
thrombocytopenia, coagulation dysfunction, parenchymal or cryoablated organ injury,
incorrect interpretation of post-cryo changes, intra vessels / intra bone gas, emboli,
myocardial infarction.
Percutaneous ablation procedure
•
Mild/moderate
adverse events: percutaneous hematoma and bleeding infection,
adjacent organ injury, CT related adverse effects: radiation, elevated creatinine and renal
function injury, reaction.
•
Severe
adverse events: percutaneous bleeding, infection, adjacent organ injury, CT
related adverse effects: radiation, acute renal injury, anaphylactic shock in reaction to
contrast agent admission, gas emboli.
