The general objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality Level 3 (or better) data on the performance, safety and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
The primary objective is to provide high-quality Level 3 (or better), data as defined by Medical Device Coordination group (MDCG) 2020-6, on the performance, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting. The hypothesis is that, when used in accordance with the instructions for use (IFU), the vascular access devices will perform safely and successfully. The Teleflex vascular access devices (index devices and accessories) in scope for this Registry vary in type from central venous access devices (CVAD) to midline catheters to peripheral catheters to hemodialysis catheters to arterial catheters navigation/tip confirmation devices. Many, but not all, of the devices also have antimicrobial and antithrombogenic properties. Also in scope are the accessories routinely used for placement and maintenance of the index devices.
Study Type
OBSERVATIONAL
Enrollment
2,500
Placement of a medical device to gain entry into the bloodstream, typically through a vein or artery, for the purpose of administering fluids, medications, blood products, or for hemodialysis
Huntsville Hospital
Huntsville, Alabama, United States
RECRUITINGLoma Linda University Health
Loma Linda, California, United States
RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
RECRUITINGCatheter devices: successful use of the device without removal due to device-related adverse events
The proportion of device uses successfully completed without device removal due to device-related adverse events
Time frame: Within 7 days after subject device removal
Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location
Successful verification of catheter tip location
Time frame: Immediately after subject device removal
Device-related adverse events
Incidence of device-related adverse events during placement or use
Time frame: Within 7 days after subject device removal
Device-related adverse events within 7 days of device removal
Incidence of device-related adverse events following removal
Time frame: Within 7 days after subject device removal
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