English
8 M-5276-559C
WARNING: Do not continue use of the catheter if still occluded or if
it is not functioning properly.
NOTE:
A small syringe provides sufficient pressure to produce a visible
stream of fluid.
Adverse Reactions
A number of serious adverse reactions have been documented for catheter
ablation procedures including pulmonary embolism, myocardial infarction, stroke,
cardiac tamponade, and death.
The following complications were also noted to have occurred during prior
studies or have been reported in the literature:
•
Catheterization/catheter procedure related: vascular bleeding/local
hematomas, thrombosis, AV fistula, pseudoaneurysm, thromboembolism
and vasovagal reactions, cardiac perforation, pericardial
effusion/tamponade, thrombi, air embolism, arrhythmias and valvular
damage, pneumothorax and hemothorax, pulmonary edema, hypoxia,
pleural effusion, acute respiratory distress syndrome (ARDS), congestive
heart failure, aspiration pneumonia, pneumonia, asthmatic attack,
hypotension, ICD lead malfunction, anemia, thrombocytopenia,
disseminated intravascular coagulation, epistaxis, systemic infection, urinary
tract infection, sedation induced apnea, sedation induced CO
2
retention with
lethargy and cholecystitis.
•
RF related: chest pain/discomfort, ventricular tachyarrhythmia, TIA, CVA,
complete heart block, coronary artery spasm, coronary artery thrombosis,
coronary artery dissection, cardiac thromboembolism, pericarditis, cardiac
perforation/tamponade, valvular damage and increased phosphokinase
level.
•
Unrelated to device or procedure: urinary retention, transient extremity
numbness, Parkinson’s disease and gastrointestinal diverticulosis.
DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ON THE PRODUCT(S)
DESCRIBED HEREIN. UNDER NO CIRCUMSTANCES SHALL
BIOSENSE WEBSTER, INC., OR ITS AFFILIATED COMPANIES, BE LIABLE
FOR ANY SPECIAL, DIRECT, INCIDENTAL, CONSEQUENTIAL, OR OTHER
DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC LAW.
WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS
AFFILIATED COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL,
DIRECT, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES, ARISING
OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE
OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW.
Descriptions and specifications appearing in Biosense Webster, Inc. printed
matter, including this publication, are informational only and meant solely to
generally describe the product at the time of manufacture and are not made or
given as a warranty of the prescribed product in any way.
WARNING: This is a controlled proprietary and confidential document.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados.
