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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

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

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

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