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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)
2018 2019 2020 2021 2022 2023
13 15 20 9 12 4

MDR Year MDR Reports MDR Events
2018 875 875
2019 788 788
2020 822 822
2021 901 901
2022 723 723
2023 243 243

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 1157 1157
Adverse Event Without Identified Device or Use Problem 859 859
Material Separation 485 485
Detachment of Device or Device Component 354 354
Output Problem 307 307
Fracture 232 232
Device Damaged by Another Device 189 189
Difficult to Remove 166 166
Material Deformation 130 130
Break 112 112
Intermittent Loss of Power 103 103
Failure to Advance 99 99
Mechanical Problem 97 97
Material Integrity Problem 94 94
Display or Visual Feedback Problem 90 90
Noise, Audible 79 79
Unintended System Motion 73 73
No Display/Image 68 68
Device Contamination with Chemical or Other Material 55 55
Defective Device 53 53
Physical Resistance/Sticking 51 51
Difficult to Advance 49 49
Unstable 46 46
Device Operates Differently Than Expected 42 42
Fluid/Blood Leak 40 40
Detachment Of Device Component 39 39
Leak/Splash 38 38
Gas/Air Leak 36 36
Material Split, Cut or Torn 32 32
Positioning Problem 28 28
Mechanical Jam 27 27
Device-Device Incompatibility 21 21
Stretched 20 20
Suction Problem 18 18
Contamination 17 17
Unsealed Device Packaging 13 13
Material Twisted/Bent 11 11
Unintended Movement 11 11
Insufficient Information 11 11
Unexpected Shutdown 11 11
Infusion or Flow Problem 9 9
Device Displays Incorrect Message 9 9
Failure to Prime 9 9
Use of Device Problem 8 8
Connection Problem 7 7
Improper Flow or Infusion 6 6
Device Dislodged or Dislocated 6 6
Device Remains Activated 6 6
Material Rupture 6 6
Device Difficult to Setup or Prepare 6 6
Difficult to Insert 6 6
Material Fragmentation 6 6
Unraveled Material 5 5
Device Contamination with Body Fluid 5 5
Difficult to Open or Close 5 5
Device Contaminated During Manufacture or Shipping 5 5
Failure to Shut Off 4 4
Power Problem 4 4
Failure to Disconnect 4 4
Tear, Rip or Hole in Device Packaging 3 3
Sticking 3 3
Pumping Stopped 3 3
Crack 3 3
Positioning Failure 3 3
Peeled/Delaminated 3 3
Failure to Power Up 3 3
Appropriate Term/Code Not Available 3 3
Activation Problem 3 3
Air/Gas in Device 3 3
Packaging Problem 3 3
Malposition of Device 3 3
Aspiration Issue 2 2
Difficult or Delayed Activation 2 2
Physical Resistance 2 2
Activation, Positioning or Separation Problem 2 2
Human-Device Interface Problem 2 2
Activation Failure 2 2
Complete Loss of Power 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Delivered as Unsterile Product 2 2
Off-Label Use 2 2
Kinked 2 2
Migration or Expulsion of Device 2 2
Hole In Material 2 2
Excess Flow or Over-Infusion 2 2
Material Puncture/Hole 2 2
Improper or Incorrect Procedure or Method 2 2
Obstruction of Flow 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Device Issue 1 1
Failure to Align 1 1
Separation Failure 1 1
Insufficient Flow or Under Infusion 1 1
Unexpected Therapeutic Results 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1256 1256
No Clinical Signs, Symptoms or Conditions 1116 1116
Foreign Body In Patient 483 483
Perforation of Vessels 434 434
Device Embedded In Tissue or Plaque 236 236
No Known Impact Or Consequence To Patient 200 200
Vascular Dissection 200 200
Death 157 157
Low Blood Pressure/ Hypotension 128 128
No Code Available 93 93
No Patient Involvement 88 88
Perforation 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 70 70
Chest Pain 68 68
Cardiac Perforation 61 61
Cardiac Arrest 52 52
Thrombus 49 49
Insufficient Information 48 48
Bradycardia 44 44
Hematoma 43 43
Vascular System (Circulation), Impaired 41 41
Myocardial Infarction 35 35
Cardiac Tamponade 29 29
Pericardial Effusion 27 27
Non specific EKG/ECG Changes 25 25
Ventricular Fibrillation 24 24
Hemorrhage/Bleeding 21 21
Pain 16 16
Ischemia 16 16
ST Segment Elevation 16 16
Pseudoaneurysm 14 14
Obstruction/Occlusion 13 13
Arrhythmia 13 13
Renal Failure 12 12
Embolism/Embolus 12 12
Tachycardia 9 9
Thrombosis 9 9
Injury 9 9
Vessel Or Plaque, Device Embedded In 8 8
Cardiopulmonary Arrest 8 8
Vasoconstriction 7 7
Hematuria 7 7
Thrombosis/Thrombus 6 6
Loss of consciousness 6 6
Cardiogenic Shock 6 6
Hemolysis 6 6
Hypersensitivity/Allergic reaction 6 6
High Blood Pressure/ Hypertension 6 6
Cardiac Enzyme Elevation 6 6
Embolism 5 5
Great Vessel Perforation 5 5
Patient Problem/Medical Problem 5 5
Complaint, Ill-Defined 5 5
Asystole 5 5
Diminished Pulse Pressure 4 4
Vomiting 4 4
Ventricular Tachycardia 4 4
Discomfort 4 4
Pulmonary Edema 4 4
Air Embolism 4 4
Atrial Fibrillation 4 4
Aneurysm 3 3
Angina 3 3
Intimal Dissection 3 3
Stroke/CVA 3 3
Dyspnea 3 3
Extravasation 3 3
Respiratory Distress 3 3
Rupture 3 3
Aortic Dissection 3 3
Heart Block 3 3
Respiratory Arrest 2 2
Diaphoresis 2 2
Intraoperative Pain 2 2
Stenosis 2 2
Sepsis 2 2
Laceration(s) 2 2
Left Ventricular Failure 2 2
Nausea 2 2
Inflammation 2 2
Calcium Deposits/Calcification 2 2
Cyanosis 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Bacterial Infection 1 1
Hemoptysis 1 1
Hemorrhage, Subdural 1 1
Fever 1 1
Foreign Body Reaction 1 1
Embolus 1 1
Encephalopathy 1 1
Occlusion 1 1
Rash 1 1
Pleural Effusion 1 1
Shock 1 1
Ventricle, Abnormality Of 1 1
Swelling 1 1
Jaundice 1 1
Dizziness 1 1
Hypervolemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-12-2022
2 Boston Scientific Corporation II Dec-15-2021
3 Boston Scientific Corporation II Dec-19-2019
4 Cardiovascular Systems Inc II Sep-11-2018
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