Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, coronary, atherectomy
Product CodeMCX
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
20 9 12 18 9 1

MDR Year MDR Reports MDR Events
2020 822 822
2021 901 901
2022 720 720
2023 708 708
2024 800 800
2025 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 1118 1118
Adverse Event Without Identified Device or Use Problem 795 795
Material Separation 509 509
Output Problem 378 378
Detachment of Device or Device Component 367 367
Difficult to Remove 160 160
Intermittent Loss of Power 159 159
Material Deformation 135 135
Material Integrity Problem 130 130
Device Damaged by Another Device 122 122
Fracture 120 120
Failure to Advance 120 120
Mechanical Problem 88 88
Display or Visual Feedback Problem 87 87
Break 80 80
Noise, Audible 79 79
Unintended System Motion 79 79
Difficult to Advance 65 65
Defective Device 59 59
Unstable 56 56
Leak/Splash 48 48
Physical Resistance/Sticking 47 47
Device Contamination with Chemical or Other Material 46 46
Mechanical Jam 43 43
Gas/Air Leak 41 41
No Display/Image 40 40
Fluid/Blood Leak 39 39
Material Split, Cut or Torn 29 29
Positioning Problem 26 26
Device-Device Incompatibility 25 25
Contamination 21 21
Material Twisted/Bent 17 17
Stretched 17 17
Insufficient Information 14 14
Unsealed Device Packaging 14 14
Suction Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Unexpected Shutdown 11 11
Connection Problem 10 10
Unintended Movement 8 8
Device Remains Activated 7 7
Device Contamination with Body Fluid 7 7
Difficult to Insert 7 7
Packaging Problem 6 6
Difficult or Delayed Activation 6 6
Device Markings/Labelling Problem 5 5
Difficult to Open or Close 5 5
Use of Device Problem 5 5
Deformation Due to Compressive Stress 5 5
Failure to Prime 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1955 1955
Foreign Body In Patient 589 589
No Consequences Or Impact To Patient 438 438
Perforation of Vessels 417 417
Vascular Dissection 233 233
Low Blood Pressure/ Hypotension 134 134
Device Embedded In Tissue or Plaque 121 121
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 96 96
Myocardial Infarction 81 81
Chest Pain 78 78
Perforation 77 77
Cardiac Arrest 71 71
Insufficient Information 65 65
No Known Impact Or Consequence To Patient 62 62
Cardiac Tamponade 39 39
Hematoma 39 39
Bradycardia 38 38
Death 38 38
Pericardial Effusion 30 30
Non specific EKG/ECG Changes 29 29
Hemorrhage/Bleeding 29 29
Obstruction/Occlusion 25 25
Thrombosis/Thrombus 25 25
Arrhythmia 23 23
No Code Available 22 22
Vascular System (Circulation), Impaired 19 19
Ischemia 19 19
Ventricular Fibrillation 18 18
Pain 15 15
Renal Failure 14 14
Embolism/Embolus 13 13
Vasoconstriction 12 12
Cardiogenic Shock 12 12
Cardiac Perforation 10 10
Cardiac Enzyme Elevation 9 9
High Blood Pressure/ Hypertension 9 9
Discomfort 8 8
Tachycardia 8 8
Angina 8 8
Hematuria 7 7
Pseudoaneurysm 7 7
Hypersensitivity/Allergic reaction 7 7
Stroke/CVA 7 7
ST Segment Elevation 7 7
No Patient Involvement 7 7
Injury 6 6
Asystole 6 6
Great Vessel Perforation 6 6
Restenosis 6 6
Heart Failure/Congestive Heart Failure 5 5

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