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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
10 5 12 10 13 18 25 16 23 13 15 20 9 12 18 3

MDR Year MDR Reports MDR Events
2014 412 412
2015 629 629
2016 713 713
2017 735 735
2018 875 875
2019 788 788
2020 822 822
2021 901 901
2022 720 720
2023 708 708
2024 194 194

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 1945 1945
Adverse Event Without Identified Device or Use Problem 1420 1420
Material Separation 589 589
Fracture 559 559
Device Damaged by Another Device 522 522
Detachment of Device or Device Component 448 448
Output Problem 367 367
Difficult to Remove 239 239
Detachment Of Device Component 207 207
Device Operates Differently Than Expected 207 207
No Display/Image 168 168
Break 163 163
Failure to Advance 154 154
Material Deformation 147 147
Intermittent Loss of Power 139 139
Material Integrity Problem 125 125
Mechanical Problem 117 117
Noise, Audible 101 101
Display or Visual Feedback Problem 100 100
Device Contamination with Chemical or Other Material 90 90
Unintended System Motion 87 87
Difficult to Advance 82 82
Fluid/Blood Leak 81 81
Defective Device 62 62
Physical Resistance/Sticking 56 56
Kinked 55 55
Leak/Splash 51 51
Device Displays Incorrect Message 51 51
Unstable 50 50
Aspiration Issue 44 44
Gas/Air Leak 38 38
Device Damaged Prior to Use 36 36
Material Split, Cut or Torn 35 35
Mechanical Jam 34 34
Insufficient Information 34 34
Positioning Problem 31 31
Sticking 27 27
Stretched 27 27
Contamination 26 26
Defective Component 24 24
Device-Device Incompatibility 23 23
Torn Material 19 19
Difficult to Insert 19 19
Unsealed Device Packaging 19 19
Suction Problem 18 18
Physical Resistance 16 16
Unintended Movement 16 16
Hole In Material 15 15
Material Twisted/Bent 14 14
Infusion or Flow Problem 14 14
Use of Device Problem 12 12
Material Fragmentation 12 12
Unexpected Shutdown 11 11
Failure to Prime 10 10
Device Dislodged or Dislocated 9 9
Connection Problem 8 8
Material Rupture 8 8
Air Leak 8 8
Thermal Decomposition of Device 7 7
Device Remains Activated 7 7
Improper Flow or Infusion 7 7
Device Contaminated During Manufacture or Shipping 5 5
Difficult to Open or Close 5 5
Power Problem 5 5
Packaging Problem 5 5
Device Markings/Labelling Problem 5 5
Device Packaging Compromised 5 5
Device Contamination with Body Fluid 5 5
Device Difficult to Setup or Prepare 5 5
Off-Label Use 5 5
Peeled/Delaminated 5 5
Overheating of Device 5 5
Unraveled Material 5 5
Failure to Power Up 4 4
Delivered as Unsterile Product 4 4
Bent 4 4
Backflow 4 4
Crack 4 4
Migration or Expulsion of Device 4 4
Insufficient Flow or Under Infusion 4 4
Difficult or Delayed Activation 4 4
Failure to Disconnect 4 4
Tear, Rip or Hole in Device Packaging 4 4
Obstruction of Flow 4 4
Failure to Shut Off 4 4
Appropriate Term/Code Not Available 3 3
Malposition of Device 3 3
No Flow 3 3
Improper or Incorrect Procedure or Method 3 3
Excess Flow or Over-Infusion 3 3
Positioning Failure 3 3
Occlusion Within Device 3 3
Pumping Stopped 3 3
Material Puncture/Hole 3 3
Activation Problem 3 3
Air/Gas in Device 3 3
Poor Visibility 2 2
Program or Algorithm Execution Failure 2 2
Complete Loss of Power 2 2
Decrease in Pressure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2637 2637
No Clinical Signs, Symptoms or Conditions 1471 1471
Perforation of Vessels 799 799
Foreign Body In Patient 630 630
Device Embedded In Tissue or Plaque 416 416
Death 357 357
Vascular Dissection 339 339
No Patient Involvement 291 291
No Known Impact Or Consequence To Patient 277 277
Low Blood Pressure/ Hypotension 173 173
Perforation 128 128
Chest Pain 126 126
No Code Available 110 110
Cardiac Arrest 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 97 97
Myocardial Infarction 76 76
Pericardial Effusion 72 72
Bradycardia 70 70
Cardiac Perforation 66 66
Insufficient Information 59 59
Intimal Dissection 58 58
Hematoma 58 58
Thrombus 58 58
Cardiac Tamponade 50 50
Obstruction/Occlusion 49 49
Ventricular Fibrillation 49 49
Vascular System (Circulation), Impaired 44 44
Hemorrhage/Bleeding 34 34
Non specific EKG/ECG Changes 32 32
ST Segment Elevation 25 25
Pain 22 22
Arrhythmia 20 20
Ischemia 19 19
Thrombosis/Thrombus 19 19
Thrombosis 18 18
Pseudoaneurysm 17 17
Tachycardia 16 16
Renal Failure 16 16
Cardiopulmonary Arrest 15 15
No Information 14 14
Embolism/Embolus 13 13
Vessel Or Plaque, Device Embedded In 13 13
Vasoconstriction 12 12
Cardiogenic Shock 12 12
Injury 11 11
Ventricular Tachycardia 11 11
Loss of consciousness 10 10
High Blood Pressure/ Hypertension 9 9
Occlusion 9 9
Pulmonary Edema 8 8
Dyspnea 8 8
Discomfort 8 8
Hematuria 7 7
Embolism 7 7
Extravasation 7 7
Stroke/CVA 7 7
Calcium Deposits/Calcification 7 7
Aneurysm 7 7
Hemolysis 6 6
Cardiac Enzyme Elevation 6 6
Hypersensitivity/Allergic reaction 6 6
Blood Loss 6 6
Diminished Pulse Pressure 6 6
Complaint, Ill-Defined 6 6
Great Vessel Perforation 6 6
Stenosis 5 5
Patient Problem/Medical Problem 5 5
Asystole 5 5
Heart Failure/Congestive Heart Failure 5 5
Vomiting 5 5
Angina 5 5
Atrial Fibrillation 5 5
Air Embolism 4 4
Respiratory Distress 4 4
Heart Block 4 4
Aortic Dissection 4 4
Loss Of Pulse 3 3
Rupture 3 3
Diaphoresis 3 3
Restenosis 3 3
Sepsis 3 3
Shock 3 3
Laceration(s) 3 3
Nausea 3 3
Left Ventricular Failure 2 2
Inflammation 2 2
Pleural Effusion 2 2
Exsanguination 2 2
Encephalopathy 2 2
Fistula 2 2
Respiratory Arrest 2 2
Unspecified Tissue Injury 2 2
Unspecified Heart Problem 2 2
Unspecified Vascular Problem 2 2
Ischemia Stroke 2 2
Low Oxygen Saturation 2 2
Sudden Cardiac Death 2 2
Dizziness 2 2
ST Segment Depression 2 2
Intraoperative Pain 2 2

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 Boston Scientific Corporation II Mar-03-2017
5 Boston Scientific Corporation I Nov-13-2015
6 Cardiovascular Systems Inc II Sep-11-2018
7 Cardiovascular Systems Inc II May-20-2017
8 Cardiovascular Systems, Inc. I Mar-20-2015
9 Cardiovascular Systems, Inc. III Feb-26-2014
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