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Uldall Double Lumen Hemodialysis Catheter Set Tray
Summary: The Uldall double lumen hemodialysis catheter set tray by Cook is used for vascular access in hemodialysis patients. Key evidence highlights its technical success and management of complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K913468 ↗
Decision Date ?
March 24, 1994
Product Code ?
LFJ
Device Class ?
Class 2
Evidence ?
0 studies
The Uldall double lumen hemodialysis catheter set tray was cleared by the FDA via the 510(k) pathway on March 24, 1994. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Uldall double lumen hemodialysis catheter is designed for providing vascular access in patients undergoing hemodialysis. It facilitates efficient blood flow for dialysis treatment.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Percutaneous placement of a double-lumen catheter to withdraw and return blood during dialysis treatment.
Clinical Applications
- Providing temporary or ongoing central venous access for hemodialysis.
- Connecting a patient to a hemodialysis circuit through separate arterial and venous catheter lumens.
- Percutaneous catheter placement when dialysis access is required and an arteriovenous fistula or graft is not available or cannot be used.
Evidence Summary
The available literature includes 7 studies ranging from 1991 to 1997, encompassing various study types such as RCTs and case series. These studies evaluate technical success, complication rates, and catheter patency.
Reported Outcomes
Published studies report that the Uldall catheter is effective in maintaining vascular access for hemodialysis, with technical success in placement and management of patency using anticoagulants. Outcomes include successful infection management by catheter exchange over a guidewire.
Safety Profile
Reported complications include septicemia, which can be managed by changing the catheter over a guidewire. Thrombus obstruction is another concern, often addressed with anticoagulants and thrombolytic agents like urokinase.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some analyses. Further research is needed to evaluate long-term outcomes and compare efficacy with newer devices.
Practical Considerations
- The catheter is generally placed into a large central vein, commonly the internal jugular, femoral, or subclavian vein, using sterile technique and imaging guidance when appropriate.
- Available catheter length and lumen configuration should match the access site, patient anatomy, and dialysis machine requirements; users should follow the current Cook instructions for use.
- Potential complications include bleeding, infection, thrombosis, catheter dysfunction, vessel injury, arrhythmia, and pneumothorax when a thoracic access site is used.
- MRI safety depends on the exact catheter materials and configuration. The current product labeling should be checked before MRI; do not assume that every Uldall catheter is MRI safe.
- The catheter is not a substitute for a functioning arteriovenous fistula or graft when permanent dialysis access can be created. It should not be used when the labeled contraindications or patient-specific risks make central venous catheterization unsafe.
Frequently Asked Questions
What are the clinical indications for Uldall double lumen hemodialysis catheter?
The catheter is indicated for use in patients requiring vascular access for hemodialysis, particularly those with difficult vascular access.
What outcomes have been reported in clinical studies?
Studies report successful catheter placement, maintenance of patency, and effective management of infections and thrombus obstructions.
What complications have been reported?
Safety data indicate complications such as septicemia and thrombus obstruction, which are managed with catheter exchange and anticoagulants.
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.