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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)
2019 2020 2021 2022 2023 2024
15 20 9 12 18 6

MDR Year MDR Reports MDR Events
2019 788 788
2020 822 822
2021 901 901
2022 720 720
2023 708 708
2024 330 330

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 1185 1185
Adverse Event Without Identified Device or Use Problem 837 837
Material Separation 520 520
Detachment of Device or Device Component 371 371
Output Problem 370 370
Fracture 173 173
Difficult to Remove 161 161
Device Damaged by Another Device 146 146
Material Deformation 139 139
Intermittent Loss of Power 139 139
Material Integrity Problem 127 127
Failure to Advance 115 115
Break 102 102
Mechanical Problem 99 99
Display or Visual Feedback Problem 92 92
Noise, Audible 87 87
Unintended System Motion 79 79
Difficult to Advance 58 58
Defective Device 57 57
Physical Resistance/Sticking 55 55
Device Contamination with Chemical or Other Material 45 45
No Display/Image 45 45
Leak/Splash 44 44
Unstable 44 44
Gas/Air Leak 37 37
Mechanical Jam 37 37
Fluid/Blood Leak 36 36
Material Split, Cut or Torn 33 33
Positioning Problem 29 29
Device-Device Incompatibility 22 22
Contamination 21 21
Stretched 20 20
Unsealed Device Packaging 15 15
Material Twisted/Bent 15 15
Suction Problem 13 13
Insufficient Information 12 12
Unintended Movement 10 10
Use of Device Problem 9 9
Failure to Prime 8 8
Difficult to Insert 8 8
Unexpected Shutdown 7 7
Infusion or Flow Problem 7 7
Packaging Problem 6 6
Device Remains Activated 6 6
Connection Problem 6 6
Device Markings/Labelling Problem 5 5
Difficult to Open or Close 5 5
Device Displays Incorrect Message 5 5
Device Contamination with Body Fluid 5 5
Off-Label Use 5 5
Device Difficult to Setup or Prepare 5 5
Improper Flow or Infusion 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Dislodged or Dislocated 4 4
Difficult or Delayed Activation 4 4
Failure to Shut Off 4 4
Power Problem 4 4
Material Fragmentation 4 4
Tear, Rip or Hole in Device Packaging 4 4
Improper or Incorrect Procedure or Method 3 3
Malposition of Device 3 3
Unraveled Material 3 3
Peeled/Delaminated 3 3
Pumping Stopped 3 3
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Air/Gas in Device 3 3
Poor Visibility 2 2
Activation Failure 2 2
Therapeutic or Diagnostic Output Failure 2 2
Program or Algorithm Execution Failure 2 2
Human-Device Interface Problem 2 2
Material Puncture/Hole 2 2
Failure to Power Up 2 2
Nonstandard Device 2 2
Delivered as Unsterile Product 2 2
Excess Flow or Over-Infusion 2 2
Crack 2 2
Positioning Failure 2 2
Defective Component 2 2
Activation, Positioning or Separation Problem 2 2
Difficult to Open or Remove Packaging Material 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Component or Accessory Incompatibility 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Obstruction of Flow 1 1
Failure to Align 1 1
Device remains implanted 1 1
Unexpected Therapeutic Results 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Smoking 1 1
Electrical /Electronic Property Problem 1 1
Deflation Problem 1 1
Difficult or Delayed Positioning 1 1
Difficult to Flush 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1557 1557
No Consequences Or Impact To Patient 817 817
Foreign Body In Patient 571 571
Perforation of Vessels 466 466
Vascular Dissection 246 246
Device Embedded In Tissue or Plaque 191 191
Low Blood Pressure/ Hypotension 137 137
No Known Impact Or Consequence To Patient 124 124
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 96 96
Death 93 93
Perforation 88 88
Chest Pain 85 85
Insufficient Information 61 61
Myocardial Infarction 57 57
Cardiac Arrest 55 55
No Code Available 54 54
Bradycardia 42 42
Hematoma 40 40
Vascular System (Circulation), Impaired 39 39
No Patient Involvement 36 36
Cardiac Tamponade 35 35
Pericardial Effusion 31 31
Non specific EKG/ECG Changes 29 29
Hemorrhage/Bleeding 28 28
Ventricular Fibrillation 22 22
Thrombosis/Thrombus 21 21
Obstruction/Occlusion 20 20
Ischemia 18 18
Pain 17 17
Thrombus 16 16
Renal Failure 14 14
Arrhythmia 14 14
Embolism/Embolus 13 13
Cardiac Perforation 13 13
Pseudoaneurysm 13 13
ST Segment Elevation 11 11
Tachycardia 9 9
High Blood Pressure/ Hypertension 9 9
Cardiogenic Shock 9 9
Cardiopulmonary Arrest 8 8
Vasoconstriction 8 8
Hematuria 7 7
Discomfort 7 7
Stroke/CVA 7 7
Cardiac Enzyme Elevation 6 6
Asystole 6 6
Angina 6 6
Injury 6 6
Hemolysis 6 6
Great Vessel Perforation 6 6
Hypersensitivity/Allergic reaction 6 6
Vessel Or Plaque, Device Embedded In 5 5
Heart Failure/Congestive Heart Failure 5 5
Diminished Pulse Pressure 5 5
Heart Block 4 4
Ventricular Tachycardia 4 4
Vomiting 4 4
Loss of consciousness 4 4
Dyspnea 3 3
Diaphoresis 3 3
Pulmonary Edema 3 3
Embolism 3 3
Air Embolism 3 3
Aneurysm 3 3
Thrombosis 3 3
Restenosis 3 3
Sepsis 3 3
Extravasation 3 3
Respiratory Distress 3 3
Stenosis 3 3
Laceration(s) 2 2
Complaint, Ill-Defined 2 2
Ischemia Stroke 2 2
Unspecified Tissue Injury 2 2
Shock 2 2
Respiratory Arrest 2 2
Hemoptysis 2 2
Calcium Deposits/Calcification 2 2
Unspecified Vascular Problem 2 2
Intraoperative Pain 2 2
Atrial Fibrillation 2 2
Left Ventricular Failure 2 2
Unspecified Heart Problem 2 2
Exsanguination 1 1
Low Oxygen Saturation 1 1
Intimal Dissection 1 1
Bacterial Infection 1 1
Ectopic Heartbeat 1 1
Patient Problem/Medical Problem 1 1
Pulmonary Hypertension 1 1
Swelling/ Edema 1 1
Cardiovascular Insufficiency 1 1
Skin Inflammation/ Irritation 1 1
Dizziness 1 1
Embolus 1 1
Blood Loss 1 1
Hemorrhage, Subdural 1 1
Rupture 1 1
Encephalopathy 1 1
Rash 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
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