BTG ICEfx - Potential Adverse Events

ICEfx™ Cryoablation System
1-9
1.7.4 After Use
• Depressurize the system after the cryoablation procedure is completed (reference Section 6.1).
• Warn people near the system about loud noise before manually depressurizing the system.
• Cut the needle and MTS tubing and dispose of the used needle and MTS in a biohazard
container in accordance with hospital and safety regulations.
• Clean the ICEfx Cryoablation System by following the instructions in Section 7.1. Do not use
cleaning agents such as Betadine or bleach solution, which may damage the touch screen.
• To avoid confusion at the beginning of a new procedure, ensure that the
o Vent Valve is closed
o Argon Shuto󰀨 Valve is in the ON position
1.8 Potential Adverse Events
Potential adverse events which may be associated with the use of cryoablation may be organ
specic or general and may include, but are not limited to abscess, adjacent organ injury, allergic/
anaphylactoid reaction, angina/ coronary ischemia, arrhythmia, atelectasis, bladder neck
contracture, bladder spasms, bleeding/hemorrhage, creatinine elevation, creation of false
urethral passage, cystitis, death, deep vein thrombosis (DVT), delayed/non healing, diarrhea,
disseminated intravascular coagulation (DIC), ecchymosis, edema/swelling, ejaculatory dysfunction,
erectile dysfunction (organic impotence), fever, stula, genitourinary perforation, glomerular
ltration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia,
idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction,
nausea, neuropathy, obstruction, organ failure pain, pelvic pain, pelvic vein thrombosis,
penile tingling/numbness, perirenal uid collection, pleural e󰀨usion, pneumothorax, probe site
paresthesia, prolonged chest tube drainage, prolonged intubation, pulmonary embolism, pulmonary
insu󰀩ciency/failure, rectal pain, rectourethral stula, renal artery/renal vein injury, renal capsule
fracture, renal failure, renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis,
scrotal edema, sepsis, skin burn/frostbite, stricture of the collection system or ureters, stroke,
thrombosis/thrombus/embolism, transient ischemic attack, tumor seeding, UPJ obstruction/
injury, urethral sloughing, urethral stricture, urinary stula, urinary frequency/urgency, urinary
incontinence, urinary leak, urinary renal leakage, urinary retention/oliguria, urinary tract infection,
vagal reaction, voiding complication including irritative voiding symptoms, vomiting, wound
complication, and wound infection.