IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
27
US User Manual
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.
Laparoscopic ablation procedure
Mild/moderate
adverse events
:
vascular and visceral injury, general anesthesia related AE,
pneumoperitoneum (that can cause hemodynamic alterations), post procedural abdominal
adhesions, abdominal wall hematoma, wound infection and fascial injury.
Severe
adverse events:
vascular and visceral injury, general anesthesia related AE, port site
metastasis, pneumoperitoneum (that can cause hemodynamic alterations), post
procedural abdominal adhesions, cryoprobe and trocar insertion include injuries to major
retroperitoneal vessels and to bowel, abdominal wall hematoma, fascial dehiscence and
herniation, umbilical hernia, and umbilical wound infection.
Breast fibroadenoma
Mild/ moderate
adverse events
:
bleeding from breast puncture site, local breast
hematoma, local breast infection and thermal injury to the breast skin, breast skin bruising,
breast swelling, ecchymosis, edema, fat necrosis.
Severe
adverse events
:
thermal injury.
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.
