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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)
2019 2020 2021 2022 2023 2024
8 10 14 6 6 0

MDR Year MDR Reports MDR Events
2019 10 10
2020 16 16
2021 24 24
2022 27 27
2023 31 31
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 69 69
Material Rupture 20 20
Difficult to Remove 13 13
Device-Device Incompatibility 10 10
Material Separation 7 7
Detachment of Device or Device Component 6 6
Inflation Problem 6 6
Deflation Problem 5 5
Retraction Problem 4 4
Material Split, Cut or Torn 4 4
Material Deformation 3 3
Material Twisted/Bent 3 3
Failure to Advance 2 2
Device Contamination with Chemical or Other Material 2 2
Device Markings/Labelling Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Entrapment of Device 2 2
Crack 2 2
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Off-Label Use 1 1
Leak/Splash 1 1
Break 1 1
Material Frayed 1 1
Device Damaged Prior to Use 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Restenosis 50 50
No Clinical Signs, Symptoms or Conditions 40 40
Hemorrhage/Bleeding 10 10
Thrombosis/Thrombus 10 10
Reocclusion 9 9
No Consequences Or Impact To Patient 8 8
Unspecified Tissue Injury 3 3
Fistula 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hematoma 2 2
High Blood Pressure/ Hypertension 2 2
Aneurysm 2 2
Chest Pain 1 1
Dyspnea 1 1
Intimal Dissection 1 1
Anaphylactic Shock 1 1
Skin Erosion 1 1
Perforation of Vessels 1 1
Peritonitis 1 1
Stenosis 1 1
Injury 1 1
Obstruction/Occlusion 1 1
Foreign Body In Patient 1 1
Vascular Dissection 1 1
Insufficient Information 1 1

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