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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
510K
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.
Clinical Applications
This device is commonly used in intensive care units for patients requiring detailed cardiac monitoring. It is particularly useful in managing patients with complex cardiac conditions, such as heart failure or myocardial infarction, where precise hemodynamic data is crucial.
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.
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.