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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 1

MDR Year MDR Reports MDR Events
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 3144 3266
Break 282 282
Failure to Advance 213 213
Difficult to Remove 133 133
Detachment of Device or Device Component 120 120
Entrapment of Device 102 102
Inflation Problem 93 93
Material Deformation 84 84
Adverse Event Without Identified Device or Use Problem 69 69
Material Integrity Problem 67 67
Leak/Splash 67 67
Difficult to Advance 60 60
Device Dislodged or Dislocated 44 44
Deflation Problem 21 21
Material Puncture/Hole 15 15
Physical Resistance/Sticking 14 14
Material Twisted/Bent 13 13
Device-Device Incompatibility 8 8
Difficult to Insert 8 8
Material Separation 7 7
Defective Device 6 6
Failure to Deflate 6 6
Fracture 6 6
Stretched 5 5
Device Markings/Labelling Problem 5 5
Unsealed Device Packaging 5 5
Device Contamination with Chemical or Other Material 5 5
Contamination 4 4
Material Split, Cut or Torn 3 3
Retraction Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Sharp Edges 2 2
Difficult to Open or Remove Packaging Material 2 2
Material Perforation 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Peeled/Delaminated 1 1
Device Damaged by Another Device 1 1
Patient Device Interaction Problem 1 1
Burst Container or Vessel 1 1
Human-Device Interface Problem 1 1
Deformation Due to Compressive Stress 1 1
Use of Device Problem 1 1
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2509 2631
No Consequences Or Impact To Patient 1461 1461
Foreign Body In Patient 25 25
Vascular Dissection 18 18
Device Embedded In Tissue or Plaque 16 16
No Known Impact Or Consequence To Patient 14 14
No Code Available 13 13
No Patient Involvement 10 10
Perforation of Vessels 9 9
Perforation 5 5
Ischemia 4 4
Chest Pain 4 4
Cardiac Arrest 3 3
Low Blood Pressure/ Hypotension 3 3
Obstruction/Occlusion 3 3
Insufficient Information 3 3
Embolism/Embolus 3 3
Thrombosis/Thrombus 2 2
Patient Problem/Medical Problem 2 2
Cardiac Tamponade 2 2
Injury 2 2
Pericardial Effusion 2 2
Hematoma 2 2
Angina 2 2
ST Segment Elevation 2 2
Shock 1 1
Thrombosis 1 1
Vasoconstriction 1 1
Myocardial Infarction 1 1
Pneumonia 1 1
Apnea 1 1
Arrhythmia 1 1
Bradycardia 1 1
Embolism 1 1
Cardiogenic Shock 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Chest Tightness/Pressure 1 1
Decreased Respiratory Rate 1 1
Cardiac Perforation 1 1
Unspecified Heart Problem 1 1

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