Contraindications
There are no known contraindications for pericardial aspiration, although recurrent effusion or unresolved tamponade may warrant surgical intervention.
Warnings
Coagulation therapy may be required for patients that have been anti-coagulated to in order to prevent excessive bleeding. The risk of bleeding (which can occur due to needle laceration of the heart, or from other causes) should therefore be weighed carefully vs. the risks and benefits of anticoagulation and any treatment given to reverse the anticoagulation before proceeding with the pericardiocentesis.
Care must be taken to ensure that there is no electrical potential difference
and that the cardiac monitor meets relevant safety standards.
• Ensure that the external portion of the guidewire is stabilized prior to
catheter introduction.
• If resistance is encountered during advancement or withdrawal of the
catheter, STOP. DO NOT CONTINUE without first determining the cause of
the resistance and taking remedial action.
• If it is necessary to reintroduce the guidewire, use extreme caution to assure
that the guidewire exits through the end hole. Damage to the catheter may
occur if the guidewire exits through a side hole.
• Movement of the patient with the straight catheter in place is not
recommended due to risk of cardiac perforation.
• Do not reintroduce effluent to patient.
• If no drainage is seen accumulating over several hours, the lumen of this
catheter may be obstructed by cellular debris. Gentle flushing of the catheter
with sterile saline may be requested by the physician.
Potential Adverse Events
Complications: The following complications have been associated with pericardial drainage procedures:
Arrhythmias, Pericarditis, Endocarditis, Hemothorax or pneumothorax, Perforation of the ventricle, atrium, or coronary vessels, Sepsis/Infection, Tamponade, Death
Strict adherence to the foregoing instructions will help reduce the incidence of complications.
Precautions
• Before use, inspect contents of the kit for physical damage including electrical insulation on the cables and other damage on the shaft of the catheter. Replace damaged components.
• Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.
• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which in turn may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
• Careful attention to aseptic technique should be employed.
• This kit should be used only by persons thoroughly trained in the techniques of pericardiocentesis.
• Take proper care to ensure that all patient-contact electrical equipment is properly isolated and grounded.
• Do not wipe catheter with organic solvents (e.g. alcohols, ethers, esters, phenols, etc.).
• CT scan, fluoroscopic, or echocardiographic examinations are recommended to evaluate needle and catheter placement.
• Pericardiocentesis should ideally be carried out in the Special Procedures Laboratory or Cardiac Catheterization Laboratory, utilizing equipment capable of cardiac monitoring. When performed at bedside, electrocardiographic monitoring should be employed continuously.
• After use, dispose of product and packaging in accordance with hospital
administrative and/or local government policy.
Trademark
PeriVac and Flexima are trademarks of Boston Scientific Corporation or its affiliates.
Product Type
Accessory
Used in Procedures
PericardiocentesisRelated Medical Areas
Cardiac Rhythm Management
