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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, coronary, atherectomy
Product CodeMCX
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
9 12 18 9 10 7

MDR Year MDR Reports MDR Events
2021 901 904
2022 720 721
2023 706 706
2024 798 798
2025 873 873
2026 437 437

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 1190 1190
Adverse Event Without Identified Device or Use Problem 979 979
Material Separation 601 601
Detachment of Device or Device Component 407 407
Output Problem 403 403
Device Damaged by Another Device 193 193
Intermittent Loss of Power 191 191
Difficult to Remove 190 190
Material Integrity Problem 152 152
Nonstandard Device 141 141
Failure to Advance 138 138
Material Deformation 122 122
Unintended System Motion 110 110
Mechanical Problem 104 104
Fracture 92 92
Difficult to Advance 86 86
Noise, Audible 79 79
Mechanical Jam 68 68
Display or Visual Feedback Problem 60 60
Unstable 58 58
Defective Device 57 57
Break 57 57
Leak/Splash 51 51
Device Contamination with Chemical or Other Material 50 50
No Display/Image 48 48
Gas/Air Leak 48 48
Fluid/Blood Leak 47 47
Improper or Incorrect Procedure or Method 44 44
Physical Resistance/Sticking 43 43
Positioning Problem 39 39
Device-Device Incompatibility 37 37
Material Split, Cut or Torn 34 34
Contamination 29 29
Deformation Due to Compressive Stress 29 29
Unexpected Shutdown 23 23
Mechanics Altered 22 22
Stretched 17 17
Insufficient Device Problem Information 15 15
Connection Problem 10 10
Unsealed Device Packaging 10 10
Device Contamination with Body Fluid 9 9
Off-Label Use 8 8
Material Twisted/Bent 8 8
Suction Problem 7 7
Device Markings/Labelling Problem 6 6
Device Remains Activated 6 6
Packaging Problem 6 6
Poor Visibility 5 5
Unintended Movement 5 5
Difficult or Delayed Activation 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2692 2694
Foreign Body In Patient 645 646
Perforation of Vessels 448 448
Vascular Dissection 270 270
Low Blood Pressure/ Hypotension 154 154
Myocardial Infarction 144 144
Cardiac Arrest 104 104
Perforation 104 104
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 88 88
Obstruction/Occlusion 80 80
Chest Pain 66 66
Insufficient Information 64 65
Reduced Blood Flow 64 64
Cardiac Tamponade 54 54
Pericardial Effusion 52 52
Bradycardia 46 46
No Consequences Or Impact To Patient 41 41
Arrhythmia 41 41
Non specific EKG/ECG Changes 39 39
Device Embedded In Tissue or Plaque 38 38
Hematoma 36 36
Hemorrhage/Blood Loss/Bleeding 33 33
Ischemia 32 32
Thrombosis/Thrombus 31 31
Embolism/Embolus 30 30
Cardiogenic Shock 29 29
Angina 21 21
Unspecified Heart Problem 21 21
Heart Failure/Congestive Heart Failure 21 21
Vasoconstriction 17 17
Pain 17 17
Restenosis 14 14
Renal Failure 13 13
Cardiac Perforation 13 13
Cardiac Enzyme Elevation 13 13
Tachycardia 13 13
Ventricular Fibrillation 12 12
Heart Block 12 12
Discomfort 11 11
Ischemia Stroke 8 8
High Blood Pressure/ Hypertension 8 8
Diminished Pulse Pressure 8 8
Stenosis 7 7
Unspecified Kidney or Urinary Problem 7 7
Pseudoaneurysm 6 6
Asystole 6 6
Hypersensitivity/Allergic reaction 6 6
Vasospasm 6 6
Hematuria 5 5
Stroke/CVA 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-12-2022
2 Boston Scientific Corporation II Dec-15-2021
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