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subclavian hemodialysis catheter
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The subclavian hemodialysis catheter is used for vascular access in hemodialysis patients. Key evidence highlights complications such as vein stenosis and hematoma.
FDA Clearance Information
Pathway
510K
Number
K884322 ↗
Decision Date
April 25, 1989
Product Code
LFJ
Device Class
Class 2
Evidence
0 studies
The subclavian hemodialysis catheter was cleared by the FDA via the 510k pathway on April 25, 1989. It is manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic and classified as Class 2.
What It Is
The subclavian hemodialysis catheter is a vascular access device designed for temporary use in patients requiring hemodialysis. It is inserted into the subclavian vein to facilitate blood flow during dialysis sessions.
Clinical Applications
This device is commonly used in patients with end-stage renal disease who require hemodialysis but do not have a permanent access site. It is typically employed in acute settings or when other access sites are not viable.
Evidence Summary
The literature includes 15 studies, comprising case series and other study types, published between 2009 and 2020. These studies explore various complications and outcomes associated with the use of subclavian hemodialysis catheters.
Reported Outcomes
Published studies report outcomes such as successful hemodialysis sessions and complications like vein stenosis and hematoma. One study noted the resolution of bleeding after surgical intervention for a chest wall hematoma.
Safety Profile
Reported complications include central vein stenosis, chest wall hematoma, and guidewire entrapment. These adverse events highlight the need for careful insertion and monitoring of the catheter.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case reports and series, which may not provide comprehensive safety and efficacy data. Further research is needed to explore long-term outcomes and preventive strategies.
Frequently Asked Questions
What are the clinical indications for subclavian hemodialysis catheter?
The device is indicated for temporary vascular access in patients requiring hemodialysis, particularly when other access sites are unavailable.
What outcomes have been reported in clinical studies?
Studies have reported successful dialysis sessions and complications such as vein stenosis and hematoma.
What complications have been reported?
Safety data indicate complications like central vein stenosis, hematoma, and guidewire entrapment.
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.