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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drug-coated peripheral transluminal angioplasty catheter
Definition Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Product CodePRC
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
14 6 6 7 10 1

MDR Year MDR Reports MDR Events
2021 24 25
2022 27 29
2023 31 31
2024 65 68
2025 275 275
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 360 364
Burst Container or Vessel 20 20
Material Rupture 15 15
Inflation Problem 12 12
Difficult to Remove 12 13
Leak/Splash 9 9
Device-Device Incompatibility 9 10
Detachment of Device or Device Component 8 9
Deflation Problem 7 7
Material Separation 5 6
Material Deformation 4 4
Insufficient Information 4 5
Improper or Incorrect Procedure or Method 3 3
Device Markings/Labelling Problem 3 3
Material Twisted/Bent 3 3
Difficult to Insert 2 2
Delivered as Unsterile Product 2 3
Retraction Problem 2 2
Failure to Advance 2 2
Device Contamination with Chemical or Other Material 2 2
Packaging Problem 2 2
Crack 2 2
Entrapment of Device 2 2
Device Damaged Prior to Use 1 1
Obstruction of Flow 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Split, Cut or Torn 1 1
Break 1 1
Flaked 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stenosis 180 180
Restenosis 117 120
No Clinical Signs, Symptoms or Conditions 76 79
Thrombosis/Thrombus 59 60
Hemorrhage/Bleeding 53 55
Insufficient Information 23 25
Obstruction/Occlusion 20 20
Aneurysm 19 19
Renal Failure 16 16
High Blood Pressure/ Hypertension 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Pain 9 9
Swelling/ Edema 7 7
Fistula 7 7
Unspecified Infection 3 3
Unspecified Tissue Injury 3 3
Pseudoaneurysm 3 3
Vascular Dissection 2 2
Hematoma 2 2
Fever 2 2
Perforation of Vessels 2 2
Tachycardia 2 2
Encephalopathy 1 1
Ischemia 1 1
Perforation 1 1
Peritonitis 1 1
Paresthesia 1 1
Cellulitis 1 1
Foreign Body In Patient 1 1
Skin Erosion 1 1
Chest Pain 1 1
Numbness 1 1
Fall 1 1
Unspecified Respiratory Problem 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular, Inc. II May-06-2022
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