📊 Evidence-Based Reference
Transvenous Balloon Tipped Flow Directed Temp Pa
Mansfield Scientific
Summary: The transvenous balloon tipped flow directed temp PA is a device used for hemodynamic monitoring. It is primarily used in critical care settings for pulmonary artery catheterization. Key evidence highlights potential complications such as misdirection and heart block.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844752 ↗
Decision Date ?
January 2, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on January 2, 1985, by Mansfield Scientific. It is classified as a Class 3 device under product code DTB.
What It Is
The transvenous balloon tipped flow directed temp PA is a catheter used for hemodynamic monitoring. It is designed to be inserted through a vein and directed by blood flow into the pulmonary artery. Its primary use is in critical care for monitoring cardiac function.
FDA-Cleared Indications
- Temporary pulmonary artery catheterization for hemodynamic monitoring
- Measurement of cardiac and pulmonary vascular pressures in patients requiring detailed cardiovascular assessment
Clinical Applications
- Temporary placement through a central vein into the right atrium, right ventricle and pulmonary artery
- Monitoring pulmonary artery and right-heart pressures in critical care
- Obtaining hemodynamic information to assist management of complex cardiac or circulatory conditions
- Use during evaluation and management of patients with severe heart failure or acute myocardial infarction when invasive monitoring is clinically indicated
Reported off-label uses
- Temporary hemodynamic monitoring during selected cardiac or vascular procedures when the catheter's labeled monitoring function is clinically useful
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes three studies, ranging from 1978 to 2025, examining the use and complications of the device. Study types include case reports and observational studies, with a focus on complications during catheterization.
Reported Outcomes
Published studies report that the device is effective for hemodynamic monitoring in critical care settings. However, there are instances of misdirection into unintended veins and the risk of complete heart block in patients with pre-existing conditions.
Safety Profile
Reported complications include misdirection of the catheter into the left pericardiophrenic vein and the development of complete heart block during catheterization in patients with left bundle-branch block. Recognition of anatomical anomalies is crucial to prevent such complications.
Evidence Limitations
The evidence is limited by the small number of studies and the observational nature of the data. Further research is needed to quantify the incidence of complications and to explore strategies for minimizing risks during catheterization.
Practical Considerations
- The catheter is advanced through venous access and guided by blood flow; fluoroscopy, pressure-waveform monitoring or other appropriate imaging may be used.
- Available dimensions, balloon volume and catheter length depend on the specific Mansfield Scientific model and should be confirmed in the original labeling.
- Potential complications include catheter misdirection, arrhythmia, pulmonary artery injury, infection, thrombosis and heart block.
- MRI safety is model-specific and cannot be assumed from the generic device name; verify the original labeling before MRI.
- Use requires trained clinicians, sterile technique and careful assessment of contraindications to central venous access or pulmonary artery catheterization.
Frequently Asked Questions
What are the clinical indications for transvenous balloon tipped flow directed temp pa?
The device is indicated for hemodynamic monitoring in critically ill patients, particularly in intensive care settings.
What outcomes have been reported in clinical studies?
Studies report effective monitoring capabilities but highlight risks such as catheter misdirection and heart block.
What complications have been reported?
Safety data indicate risks of catheter misdirection and complete heart block, particularly in patients with left bundle-branch block.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.