Steerable Diagnostic Electrode Catheter

INTENDED USE
EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are intended for temporary intracardiac sensing, recording, stimulation, and temporary pacing during the evaluation of cardiac arrhythmias. The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.

INDICATIONS FOR USE
EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

CONTRAINDICATIONS
The EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are contraindicated in patients:
• with active systemic infection;
• with conditions where insertion into or manipulation in the cardiac chambers is unsafe as this may increase the risk of perforation or systemic embolic event, such as but not limited to, evidence of myxoma, Left Atrial (LA) thrombus, or intracardiac mural thrombus, or interatrial baffle or patch;
• with a mechanical prosthetic heart valve through which the catheter must pass;
• with aortic valve replacement via a retrograde transaortic approach;
• with vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach;
• with any of the EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters inserted, and a need to undergo imaging inside a Magnetic Resonance Imager (MRI);
• who are hemodynamically unstable; and/or
• with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe, such as but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, Coronary Artery Bypass Graft [CABG], PTCA/PCI/ coronary stent procedure/ unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g. severe rotational anomalies of the heart or great vessels).

WARNINGS

• Cardiac catheterization procedures should be performed only by physicians thoroughly trained in invasive cardiology and in the specific approach to be used, in a fully-equipped electrophysiology lab.
• Before using, inspect the EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters for any defects or physical damage, including electrical insulation on the cables and the catheter shaft that, if used, may cause patient and/or user injury. Do not use defective or damaged devices. Replace damaged equipment if necessary. No modification of this equipment is allowed.
• Contents are supplied sterile using an EO process and should be used by the “Use By” date on the device package. Do not use the device if past the “Use By” date. Do not use if the sterile barrier is damaged as use of non-sterile devices may result in patient injury. If damage is found, call your BSC representative.
• Cardiac catheterization procedures present the potential for significant radiation exposure, which can result in acute radiation injury as well as an increased risk for somatic and genetic effects, to both patients and laboratory staff due to the radiation beam intensity and duration of the fluoroscopic imaging. Cardiac catheterization procedures should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps have been taken to minimize this exposure. Careful consideration must therefore be given for this use of the device in pregnant people. The long-term risk of protracted fluoroscopy has not been established. Therefore, careful consideration must be given for the use of the device in prepubescent children.
• To ensure correct clinical therapeutic decisions derived from cardiac mapping, the physician must verify results and catheter location using other visualization techniques including but not limited to fluoroscopy, ultrasound, and/or pace mapping.
• If a sheath is used, pre-size the catheter to the inner diameter of the sheath prior to insertion to reduce the incidence of catheter entrapment within the sheath requiring removal of the sheath catheter assembly, loss of the insertion site, and possibly aborting the procedure.
• All equipment used in connection with the BSC Catheter must meet IEC 60601-1 requirements, including those for use with Type CF Defibrillation-Proof applied parts, as well as any other relevant regulatory and safety standards. The use of catheter with devices that do not comply with relevant standards may cause equipment damage or system malfunction, or harm to the patient or user requirements for the specified intended use.
• Stimulation of cardiac tissues caused by pacing stimuli may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns.
• Catheter advancement should be done using electrogram and fluoroscopic guidance to the targeted endocardial site. At no time should the EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters be advanced or withdrawn when resistance is felt, without determining the cause. Valve damage, lead displacement, vascular and/or cardiac perforation, and/or tamponade are risks with any intracardiac catheter.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac catheterization procedures. The potential for catheter entrapment may be increased when the catheter is over torqued and/or positioned in the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.
• Do not insert or withdraw the catheter without straightening the catheter tip (returning the steering lever to the neutral position) to prevent entanglement/entrapment within the cardiac structure or other device that may result in myocardial trauma and/or may require additional medical/surgical intervention.
• Excessive bending or kinking of the catheter shaft may damage internal wires. Manual pre-bending of the distal curve can damage the steering mechanism and/or electrical wires and may cause patient injury.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life-threatening adverse events. Perform mapping and pacing with extreme caution.
• Do not use these catheters as an internal defibrillation catheter. Doing so may result in perforation, arrhythmias, embolism, thrombus, and/or patient death.
• Guiding catheters and/or long introducer sheaths present the potential for thromboembolic events. Pre-flush and maintain lumen patency with heparinized intravenous infusion.
• Do not wipe the catheter with organic solvents such as alcohol or immerse the handle cable connector in fluids. This may result in electrical or mechanical catheter failures. It may also result in an allergic reaction from the patient.
• Do not ablate over the diagnostic electrodes on the EP XT, Dynamic Tip and Dynamic XT Unidirectional Steerable Diagnostic Catheters. Contact between the ablation catheter tip and the diagnostic electrode may create or aid in transference of char and/or coagulum and may result in embolism and/or damage to the catheter.
• The use of this device in conjunction with cardiac ablation, as part of the diagnosis and treatment of arrhythmias, may pose an increased risk of adverse events, such as cardiac perforation, tamponade, myocardial infarction, cerebral vascular accident, embolism, and hematoma requiring medical intervention, surgical repair, and/or blood transfusion.
• Patients with an implanted Pulse Generator (PG) may experience transient interference from programmed electrical stimulation during a diagnostic electrophysiology study.
• Use caution during a diagnostic electrophysiology study for patients with implanted cardiac leads to prevent entanglement of the catheter and lead(s).
• Exercise caution when performing an RF cardiac ablation procedure in patients with implanted Pulse Generator (PG) devices. Induction of arrhythmias and changes in PG function can occur. Contact the manufacturer of the PG for guidelines and programming recommendations during an ablation procedure to minimize risk to the patient and device.
• Ensure that the Electrogram (EGM) recorder pacing stimulator is not active when connecting the EP XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters to reduce the risk of initiating an arrhythmia.
• This device is for single use only. Reuse, reprocessing, and/ or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.
• The use of catheters or cables with unprotected male pin connectors present a risk of electrical hazard. Inadvertent attachment of pin connectors to power supply sockets or connectors could result in electrocution of the patient or operator.
• Carefully read all equipment and ancillary device instructions required for the procedure prior to use. Observe all contraindications, warnings, and precautions noted in these instructions. Failure to do so may result in patient complications.
• Administer appropriate levels of peri-procedural anticoagulation therapy for selected patients undergoing right-sided procedures. Administer anticoagulation therapy during and post-procedure according to institution standards to minimize bleeding and thrombotic complications.
• This catheter is not indicated for use in cardiac ablation or coronary artery mapping.
• Ensure that the cable/catheter connection remains dry throughout the procedure to prevent electric shock or other patient injuries as well as to prevent loss of device function.
• Fibrin may accumulate in or on the sheath/catheter assembly during the procedure. Aspirate when removing the dilator or catheter.
• In the presence of anticoagulation, there may be an increased risk of bleeding from all causes.
• There are no data to support the safety and effectiveness of this device in the pediatric population.
• Any serious incident that has occurred in relation to the device should be reported to BSC and the competent authority of the Member State in which the user and/or patient is established.

PRECAUTIONS
• Use only sterile saline or water to wipe this catheter.
• Ensure that the cable/catheter connection remains dry throughout the procedure. Avoid submerging the catheter handle in any solution.
• Do not use the EP XT, Dynamic Tip, or Dynamic XT Unidirectional Steerable Diagnostic Catheters closer than 30 cm (12 inches) to any Wireless Power Transfer (WPT) and 5G cellular devices, otherwise electromagnetic interference from those devices could result in degradation of the performance of this equipment.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the use of the steerable diagnostic catheters include, but are not limited to:
• Pain or discomfort, for example:
        o Angina
        o Chest pain
        o Non-cardiovascular pain
• Cardiac arrest
• Death
• Hypertension
• Hypotension
• Infection/inflammation/exposure to biohazardous material
• Edema/heart failure/pleural effusion
• Procedural related side effects, for example:
        o Allergic reaction (including anaphylaxis)
        o Genitourinary complication
        o Side effects related to medication or anesthesia
        o Radiation injury
        o Renal failure/insufficiency
• Gastrointestinal disorders
• Vasovagal response
• Respiratory distress/insufficiency/failure/dyspnea
• Arrhythmia (new or exacerbated)
• Conduction pathway injury (heart block, nodal injury, etc.)
• Vessel trauma, including:
        o Perforation
        o Dissection
        o Coronary artery injury
        o Vasospasm
        o Occlusion
        o Hemothorax
• Cardiac trauma, for example:
        o Cardiac perforation/cardiac tamponade/pericardial effusion
• Valvular damage
• Injury related to tissue damage and/or adjacent structures, for example:
        o Catheter entrapment
        o Physical trauma
• Surgical and access complications, for example:
        o Hematoma/seroma
        o AV fistula
        o Bleeding
        o Pseudoaneurysm
        o Pneumothorax
        o Thrombosis
• Injury due to embolism/thromboembolism/air embolism/ foreign body embolism:
        o Cerebrovascular Accident (CVA)/stroke
        o Transient Ischemia Attack (TIA)
        o Myocardial infarction
        o Pulmonary embolism
        o Asymptomatic cerebral embolism
        o Neurological impairment and its symptoms, for example:
                        o Cognitive changes, visual disturbances, headache, motor impairment, sensory impairment, and speech impairment

The potential adverse events may be related to the catheter(s) and/or the interventional procedure. The severity and/or the frequency of these potential adverse events may vary and may result in prolonged procedure time and/or additional medical and/ or surgical intervention, implantation of a permanent device such as a pacemaker, and in rare cases, may result in death.
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