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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)
2020 2021 2022 2023 2024 2025
10 14 6 6 7 10

MDR Year MDR Reports MDR Events
2020 16 16
2021 24 25
2022 27 29
2023 31 31
2024 65 68
2025 267 267

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 354 358
Material Rupture 20 20
Burst Container or Vessel 17 17
Difficult to Remove 14 15
Inflation Problem 11 11
Device-Device Incompatibility 10 11
Leak/Splash 7 7
Deflation Problem 7 7
Material Separation 7 8
Detachment of Device or Device Component 7 8
Insufficient Information 4 5
Material Deformation 4 4
Device Markings/Labelling Problem 3 3
Material Twisted/Bent 3 3
Retraction Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Material Split, Cut or Torn 2 2
Entrapment of Device 2 2
Crack 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 3
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Advance 2 2
Material Frayed 1 1
Break 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Damaged Prior to Use 1 1
Difficult to Advance 1 1
Obstruction of Flow 1 1
No Apparent Adverse Event 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stenosis 171 171
Restenosis 116 119
No Clinical Signs, Symptoms or Conditions 73 76
Thrombosis/Thrombus 56 57
Hemorrhage/Bleeding 52 54
Insufficient Information 23 25
Obstruction/Occlusion 20 20
Aneurysm 19 19
Renal Failure 16 16
High Blood Pressure/ Hypertension 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Pain 9 9
Swelling/ Edema 7 7
Fistula 7 7
No Consequences Or Impact To Patient 6 6
Reocclusion 3 3
Unspecified Tissue Injury 3 3
Pseudoaneurysm 3 3
Unspecified Infection 2 2
Vascular Dissection 2 2
Hematoma 2 2
Fever 2 2
Perforation of Vessels 2 2
Tachycardia 2 2
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
Dyspnea 1 1
Fall 1 1
Unspecified Respiratory Problem 1 1
Intimal Dissection 1 1

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