Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 1 4 8 10 14 6 6 0

MDR Year MDR Reports MDR Events
2017 2 2
2018 11 11
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 70 70
Material Rupture 27 27
Difficult to Remove 16 16
Device-Device Incompatibility 11 11
Deflation Problem 9 9
Detachment of Device or Device Component 7 7
Material Separation 7 7
Inflation Problem 6 6
Material Split, Cut or Torn 6 6
Retraction Problem 5 5
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
Difficult to Insert 2 2
Delivered as Unsterile Product 2 2
Entrapment of Device 2 2
Break 2 2
Crack 2 2
Material Frayed 1 1
Off-Label Use 1 1
Leak/Splash 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
Torn Material 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
No Consequences Or Impact To Patient 17 17
Hemorrhage/Bleeding 10 10
Thrombosis/Thrombus 10 10
Reocclusion 9 9
Injury 4 4
Unspecified Tissue Injury 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fistula 3 3
Hematoma 2 2
Aneurysm 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 1 1
Skin Erosion 1 1
Perforation of Vessels 1 1
Rupture 1 1
Peritonitis 1 1
Stenosis 1 1
Bradycardia 1 1
Chest Pain 1 1
Dyspnea 1 1
Intimal Dissection 1 1
Anaphylactic Shock 1 1
Insufficient Information 1 1
Obstruction/Occlusion 1 1
Foreign Body In Patient 1 1
Vascular Dissection 1 1

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