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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, hemostasis, vascular
Product CodeMGB
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
23 27 10 17 11 2

MDR Year MDR Reports MDR Events
2018 5679 5679
2019 6156 6156
2020 5927 5927
2021 7586 7586
2022 9457 9466

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 13084 13084
Material Separation 3887 3887
Improper or Incorrect Procedure or Method 1977 1977
Malposition of Device 1958 1958
Adverse Event Without Identified Device or Use Problem 1536 1536
Device Operates Differently Than Expected 1196 1196
Patient Device Interaction Problem 1079 1079
Difficult to Remove 973 973
Insufficient Information 971 971
Activation, Positioning or Separation Problem 960 960
Entrapment of Device 951 951
Detachment of Device or Device Component 901 901
Difficult to Insert 890 890
Off-Label Use 860 860
Difficult to Open or Close 757 757
Obstruction of Flow 734 734
Positioning Failure 696 696
Activation Failure 612 612
Material Deformation 599 599
Physical Resistance/Sticking 572 572
Mechanical Jam 534 534
Break 531 531
Detachment Of Device Component 455 455
Failure to Advance 455 455
Decrease in Pressure 434 434
Retraction Problem 374 374
Material Rupture 358 358
Failure to Fire 352 352
Difficult to Advance 300 300
Product Quality Problem 290 290
Deformation Due to Compressive Stress 258 258
Misconnection 221 221
Unintended System Motion 165 165
Material Split, Cut or Torn 157 157
Component Missing 143 143
Appropriate Term/Code Not Available 141 150
Difficult or Delayed Activation 124 124
Premature Activation 118 118
Firing Problem 116 116
Failure to Cut 115 115
Difficult or Delayed Positioning 112 112
Positioning Problem 103 103
Material Twisted/Bent 97 97
Therapy Delivered to Incorrect Body Area 95 95
Inadequate or Insufficient Training 94 94
Activation Problem 94 94
Device Damaged by Another Device 88 88
Unintended Movement 84 84
Migration 83 92
Burst Container or Vessel 80 80
Separation Failure 78 78
Partial Blockage 73 73
Migration or Expulsion of Device 72 72
Noise, Audible 71 71
Use of Device Problem 67 76
Deflation Problem 61 61
Material Puncture/Hole 58 58
Defective Component 57 57
Kinked 53 53
Loosening of Implant Not Related to Bone-Ingrowth 45 45
No Apparent Adverse Event 42 42
Therapeutic or Diagnostic Output Failure 40 40
Component Misassembled 39 39
Material Frayed 37 37
Fracture 35 35
Bent 34 34
Expulsion 33 33
Difficult To Position 32 32
Defective Device 31 31
Leak/Splash 30 30
Crack 29 29
Patient-Device Incompatibility 26 26
Misfire 21 21
Device Dislodged or Dislocated 20 20
Mechanical Problem 20 20
Material Fragmentation 19 19
Accessory Incompatible 19 19
Loose or Intermittent Connection 17 17
Physical Property Issue 15 15
Unsealed Device Packaging 14 14
Stretched 14 14
Separation Problem 13 13
Peeled/Delaminated 11 11
Device Contamination with Chemical or Other Material 11 11
Material Integrity Problem 10 10
Output Problem 9 9
Contamination /Decontamination Problem 8 8
Difficult to Flush 8 8
Failure to Seal 8 8
Image Orientation Incorrect 7 7
Failure to Deliver 7 7
Device Operational Issue 6 6
Pressure Problem 6 6
Torn Material 6 6
Scratched Material 5 5
Device Damaged Prior to Use 5 5
Device Issue 4 4
Physical Resistance 4 4
Failure to Form Staple 4 4
No Flow 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14927 14936
No Consequences Or Impact To Patient 14134 14134
Blood Loss 937 937
Hematoma 848 857
Hemorrhage/Bleeding 709 709
Insufficient Information 481 481
Obstruction/Occlusion 421 421
Tissue Damage 419 419
Pain 366 366
Pseudoaneurysm 326 335
Occlusion 324 324
Unspecified Tissue Injury 320 320
No Known Impact Or Consequence To Patient 309 309
Foreign Body In Patient 301 301
Extravasation 233 233
No Information 215 215
Vascular Dissection 175 175
No Code Available 134 134
Intimal Dissection 132 132
Stenosis 127 127
Unspecified Infection 122 122
Thrombosis 110 110
Thrombosis/Thrombus 106 106
Low Blood Pressure/ Hypotension 98 98
No Patient Involvement 97 97
Ischemia 90 90
Death 81 81
Swelling/ Edema 76 76
Device Embedded In Tissue or Plaque 67 67
Diminished Pulse Pressure 65 65
Perforation 51 51
Perforation of Vessels 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 53
Failure of Implant 37 37
Retroperitoneal Hemorrhage 36 36
Inflammation 35 35
Swelling 35 35
Numbness 35 35
Fistula 33 33
Embolism 29 29
Anemia 28 28
Embolism/Embolus 26 26
Aneurysm 22 22
Stroke/CVA 21 21
Renal Failure 20 20
Bruise/Contusion 18 18
Calcium Deposits/Calcification 18 18
Shock 17 17
Sepsis 16 16
Claudication 16 16
Vessel Or Plaque, Device Embedded In 16 16
Laceration(s) 15 24
Nerve Damage 14 14
Hypersensitivity/Allergic reaction 14 14
Loss Of Pulse 14 14
Thrombus 14 14
Cardiac Arrest 13 13
Hemostasis 12 12
Myocardial Infarction 12 12
Abscess 11 11
Local Reaction 11 11
Rupture 10 10
Discomfort 10 10
Post Operative Wound Infection 10 10
Fever 10 10
Unspecified Vascular Problem 10 10
Rash 9 9
Ecchymosis 9 9
Prolapse 9 9
Foreign Body Embolism 8 8
Dizziness 7 7
Hypovolemic Shock 7 7
Tachycardia 6 6
Skin Discoloration 6 6
Vascular System (Circulation), Impaired 6 6
Loss of consciousness 6 6
Injury 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Patient Problem/Medical Problem 6 6
Thromboembolism 5 5
Multiple Organ Failure 5 5
Implant Pain 5 5
Skin Infection 5 5
Cardiogenic Shock 5 5
Discharge 5 5
Vasoconstriction 5 5
Chest Pain 5 5
Bacterial Infection 5 5
Bradycardia 5 5
Abdominal Pain 5 5
Arrhythmia 4 4
Cellulitis 4 4
Embolus 4 4
Erythema 4 4
High Blood Pressure/ Hypertension 4 4
Dyspnea 4 4
Fatigue 4 4
Weakness 4 4
Scar Tissue 4 4
Ambulation Difficulties 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Medical Corp II Jun-29-2018
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