VIKING™, VIKING™ SoftTip and TANGO™ Fixed Curve Diagnostic Electrode Catheter

INTENDED USE/INDICATIONS FOR USE

INTENDED USE

The VIKING Fixed Curve Diagnostic Catheter is 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

The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

CONTRAINDICATIONS

The VIKING Fixed Curve Diagnostic Catheter is contraindicated for use:

• in patients with a mechanical prosthetic heart valve through which the catheter must pass;
• in patients with active systemic infection;
• in patients 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, intracardiac mural thrombus, or interatrial baffle or patch;
• from the femoral approach in patients who have vena cava embolic protection filter devices or known femoral thrombus;
• in patients who are hemodynamically unstable;
• in patients 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.
• 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.
• Before using, inspect the VIKING Fixed Curve Diagnostic Catheter 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.
• The use of catheters or cables with unprotected male pin connectors presents a risk of electrical hazard. Inadvertent attachment of pin connectors to power supply sockets of connectors could result in electrocution of the patient or operator.
• Do not use the VIKING Fixed Curve Diagnostic Catheter as an internal defibrillation catheter. Doing so may result in perforation, arrhythmias, embolism, thrombus, and/or patient death.
• 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 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. Due to radiation exposure during cardiac catheterization, the safety and effectiveness of this device has not yet been established in pregnant and/or nursing women and pediatric patients.
• Careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade. Catheter advancement should be performed under fluoroscopic guidance. Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
• 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.
• 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.
• Do not use if package is opened or damaged.
• 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.
• 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 in order 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.
• Warnings for patients with implantable pacemakers and implantable cardioverter/ defibrillators (ICDs):
  • Have temporary external sources of pacing and defibrillation available.
  • Fluoroscopic or appropriate imaging guidance and care must be taken during catheter advancement, manipulation, and withdrawal to avoid lead dislodgement.
  • Monitor pre- and post-measurements for sensing and pacing thresholds and impedances to determine the integrity of the lead-patient function.
  • Temporarily Deactivate ICDs for the duration of the procedure as they could discharge and injure the patient or be damaged by the procedure.
  • Perform a complete analysis of the implanted device function after any electrophysiology procedure.
  • Remember to reactivate the pulse generator after the procedure.
• At no time should the VIKING Fixed Curve Diagnostic Catheter be advanced or withdrawn when resistance is felt without determining the cause. Valve damage, vascular and/or cardiac perforation is a risk 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.
• There are no data to support the safety and effectiveness of this device in the pediatric population.
• Excessive bending or kinking of the catheter shaft may damage internal wires. Manual prebending of the distal curve can damage the electrical wires and may cause patient injury.
• Use both fluoroscopy or other visualization technique, such as echocardiography, and electrograms to monitor the advancement of the catheter to the area of the endocardium under investigation to avoid conduction pathway injury, cardiac perforation or tamponade.
• 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 this 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.
• This catheter has not been validated in an MRI environment. Do not use the VIKING Fixed Curve Diagnostic Catheter near MRI equipment. Doing so may result in movement or heating of the catheter, which may cause distortion/loss of the catheter image on electroanatomic mapping. This could lead to patient injuries such as cardiac trauma.
• Portable radiofrequency (RF) communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VIKING Fixed Curve Diagnostic Catheter, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• 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

• Before using, check shelf life. Do not use catheter after expiration date.
• Before using, inspect for physical damage, including electrical insulation on the cables and the catheter shaft. Replace damaged equipment.
• Do not use the VIKING Fixed Curve Diagnostic Catheter 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 VIKING Fixed Curve Diagnostic Catheter include, but are not limited to:

• Pain or discomfort, for example:
  • Angina
  • Chest pain
  • 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:
  • Allergic reaction (including anaphylaxis)
  • Genitourinary complication
  • Side effects related to medication or anesthesia
  • Radiation injury
  • 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:
  • Perforation
  • Dissection
  • Coronary artery injury
  • Vasospasm
  • Occlusion
  • Hemothorax
• Cardiac trauma, for example:
  • Cardiac perforation/cardiac tamponade/pericardial effusion
  • Valvular damage
• Injury related to tissue damage and/or adjacent structures, for example:
  • Catheter entrapment
  • Physical trauma
• Surgical and access complications, for example:
  • Hematoma/seroma
  • AV fistula
  • Bleeding
  • Pseudoaneurysm
  • Pneumothorax
• Thrombosis
• Injury due to embolism/thromboembolism/air embolism/ foreign body embolism:
  • Cerebrovascular Accident (CVA)/stroke
  • Transient Ischemic Attack (TIA)
  • Myocardial infarction
  • Pulmonary embolism
  • Asymptomatic cerebral embolism
  • Neurological impairment and its symptoms, for example:
    • 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.

91099680 (REV AC)