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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ablation catheter, renal denervation
Definition For denervating the renal nerves to lower blood pressure
Product CodeQYI
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 3 13 7 1

MDR Year MDR Reports MDR Events
2024 17 18
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Material Deformation 5 5
Difficult to Insert 4 4
Insufficient Information 3 3
Expiration Date Error 3 3
Positioning Problem 3 3
Entrapment of Device 2 2
Detachment of Device or Device Component 2 2
Failure to Cycle 2 2
Incomplete or Inadequate Connection 1 1
Unsealed Device Packaging 1 1
Defective Device 1 2
Difficult to Remove 1 1
High Readings 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Device Damaged by Another Device 1 1
Fracture 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Vascular Dissection 5 5
Thrombosis/Thrombus 4 4
Insufficient Information 3 3
High Blood Pressure/ Hypertension 2 2
Obstruction/Occlusion 2 3
Bradycardia 2 2
Abdominal Pain 1 1
Syncope/Fainting 1 1
Stroke/CVA 1 1
Hematoma 1 1
Malaise 1 1
Pain 1 2
Asystole 1 1
Pseudoaneurysm 1 1
Low Oxygen Saturation 1 1
Device Embedded In Tissue or Plaque 1 1

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