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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Definition To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Product CodeNWX
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
4 2 5 1 4 0 0 8 9 6 7 15 7 16 13 1

MDR Year MDR Reports MDR Events
2014 14 14
2015 203 203
2016 324 324
2017 351 351
2018 463 463
2019 708 708
2020 728 728
2021 794 916
2022 754 754
2023 835 835
2024 244 244

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 4070 4192
Break 403 403
Failure to Advance 286 286
Difficult to Remove 178 178
Detachment of Device or Device Component 149 149
Entrapment of Device 128 128
Inflation Problem 108 108
Material Deformation 103 103
Leak/Splash 95 95
Adverse Event Without Identified Device or Use Problem 84 84
Difficult to Advance 69 69
Material Integrity Problem 68 68
Detachment Of Device Component 63 63
Device Dislodged or Dislocated 46 46
Deflation Problem 35 35
Device Damaged Prior to Use 23 23
Material Puncture/Hole 17 17
Fracture 15 15
Physical Resistance/Sticking 15 15
Material Twisted/Bent 13 13
Material Separation 13 13
Kinked 10 10
Device-Device Incompatibility 9 9
Stretched 8 8
Difficult to Insert 8 8
Device Contamination with Chemical or Other Material 7 7
Failure to Deflate 6 6
Device Markings/Labelling Problem 6 6
Defective Device 6 6
Fluid/Blood Leak 6 6
Hole In Material 5 5
Unsealed Device Packaging 5 5
Retraction Problem 4 4
Sticking 4 4
Contamination 4 4
Device Damaged by Another Device 4 4
Difficult to Open or Remove Packaging Material 3 3
Physical Resistance 3 3
Improper or Incorrect Procedure or Method 3 3
Material Split, Cut or Torn 3 3
Burst Container or Vessel 3 3
Bent 3 3
Defective Component 3 3
Peeled/Delaminated 3 3
Inadequacy of Device Shape and/or Size 2 2
Use of Device Problem 2 2
Unraveled Material 2 2
Torn Material 2 2
Sharp Edges 2 2
Material Perforation 2 2
Device Or Device Fragments Location Unknown 1 1
Deformation Due to Compressive Stress 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Mechanical Jam 1 1
No Apparent Adverse Event 1 1
Patient Device Interaction Problem 1 1
Human-Device Interface Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Failure to Unfold or Unwrap 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Frayed 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Disconnection 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2639 2639
No Clinical Signs, Symptoms or Conditions 2509 2631
No Patient Involvement 92 92
No Known Impact Or Consequence To Patient 45 45
Foreign Body In Patient 26 26
Device Embedded In Tissue or Plaque 26 26
Vascular Dissection 24 24
Atherosclerosis 17 17
No Code Available 16 16
Perforation of Vessels 14 14
Ischemic Heart Disease 14 14
Intimal Dissection 6 6
No Information 6 6
Perforation 5 5
Injury 5 5
Obstruction/Occlusion 5 5
Ischemia 4 4
Chest Pain 4 4
Death 4 4
Cardiac Arrest 3 3
Low Blood Pressure/ Hypotension 3 3
Insufficient Information 3 3
Embolism/Embolus 3 3
Thrombosis/Thrombus 2 2
Pericardial Effusion 2 2
Patient Problem/Medical Problem 2 2
Atrial Perforation 2 2
Chest Tightness/Pressure 2 2
Cardiac Tamponade 2 2
Cardiogenic Shock 2 2
ST Segment Elevation 2 2
Angina 2 2
Embolism 2 2
Hematoma 2 2
Peripheral Vascular Disease 2 2
Pneumonia 1 1
Myocardial Infarction 1 1
Apnea 1 1
Arrhythmia 1 1
Cardiopulmonary Arrest 1 1
Bradycardia 1 1
Calcium Deposits/Calcification 1 1
Shock 1 1
Thrombosis 1 1
Tissue Damage 1 1
Vasoconstriction 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Decreased Respiratory Rate 1 1
Cardiac Perforation 1 1
Unspecified Heart Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AngioScore Inc. I Aug-18-2010
2 Spectranetics Corporation II Nov-26-2019
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