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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)
2019 2020 2021 2022 2023 2024
7 15 7 16 13 5

MDR Year MDR Reports MDR Events
2019 708 708
2020 728 728
2021 794 916
2022 754 754
2023 835 835
2024 619 619

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3386 3508
Break 311 311
Failure to Advance 227 227
Difficult to Remove 146 146
Detachment of Device or Device Component 137 137
Entrapment of Device 113 113
Inflation Problem 105 105
Adverse Event Without Identified Device or Use Problem 99 99
Material Deformation 95 95
Leak/Splash 87 87
Material Integrity Problem 82 82
Difficult to Advance 63 63
Device Dislodged or Dislocated 47 47
Deflation Problem 22 22
Material Puncture/Hole 18 18
Physical Resistance/Sticking 16 16
Material Twisted/Bent 14 14
Difficult to Insert 10 10
Failure to Deflate 8 8
Material Separation 8 8
Device-Device Incompatibility 8 8
Contamination 6 6
Defective Device 6 6
Fracture 6 6
Fluid/Blood Leak 6 6
Stretched 5 5
Unsealed Device Packaging 5 5
Device Markings/Labelling Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Material Split, Cut or Torn 4 4
Sharp Edges 2 2
Retraction Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Improper or Incorrect Procedure or Method 2 2
Patient Device Interaction Problem 1 1
Air/Gas in Device 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Positioning Problem 1 1
Material Perforation 1 1
Device Damaged by Another Device 1 1
Peeled/Delaminated 1 1
Packaging Problem 1 1
Burst Container or Vessel 1 1
Inadequacy of Device Shape and/or Size 1 1
No Apparent Adverse Event 1 1
Device Contaminated During Manufacture or Shipping 1 1
Human-Device Interface Problem 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2863 2985
No Consequences Or Impact To Patient 1461 1461
Foreign Body In Patient 32 32
Vascular Dissection 27 27
Device Embedded In Tissue or Plaque 16 16
No Known Impact Or Consequence To Patient 14 14
Perforation of Vessels 13 13
No Code Available 13 13
No Patient Involvement 10 10
Perforation 6 6
Obstruction/Occlusion 5 5
Chest Pain 4 4
Cardiac Arrest 4 4
Pericardial Effusion 4 4
Ischemia 4 4
Embolism/Embolus 3 3
Hematoma 3 3
Insufficient Information 3 3
Low Blood Pressure/ Hypotension 3 3
Cardiac Tamponade 2 2
Angina 2 2
Injury 2 2
Thrombosis/Thrombus 2 2
Bradycardia 2 2
Shock 2 2
Unspecified Heart Problem 2 2
ST Segment Elevation 2 2
Patient Problem/Medical Problem 2 2
Vasoconstriction 1 1
Chest Tightness/Pressure 1 1
Respiratory Arrest 1 1
Cardiac Perforation 1 1
Complaint, Ill-Defined 1 1
Arrhythmia 1 1
Thrombosis 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Pneumonia 1 1
Apnea 1 1
Embolism 1 1
Myocardial Infarction 1 1
Air Embolism 1 1
Hemorrhage/Bleeding 1 1
Decreased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corporation II Nov-26-2019
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