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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reverse central venous recanalization system
Definition A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.
Product CodeQJH
Regulation Number 870.1342
Device Class 2


Premarket Reviews
ManufacturerDecision
BLUEGRASS VASCULAR TECHNOLOGIES, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Respiratory Arrest 1 1
Exsanguination 1 1
Hematoma 1 1
Perforation 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
Extravasation 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Great Vessel Perforation 1 1
Hemothorax 1 1

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