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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device device, hemostasis, vascular
Product CodeMGB
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
27 10 17 11 18 9

MDR Year MDR Reports MDR Events
2019 6156 6156
2020 5927 5927
2021 7586 7586
2022 9457 9466
2023 13529 13529
2024 5839 5839

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 24106 24106
Material Separation 5443 5443
Malposition of Device 2288 2288
Improper or Incorrect Procedure or Method 2157 2157
Adverse Event Without Identified Device or Use Problem 1529 1529
Insufficient Information 1404 1404
Patient Device Interaction Problem 1398 1398
Activation, Positioning or Separation Problem 1394 1394
Off-Label Use 1389 1389
Entrapment of Device 1259 1259
Difficult to Open or Close 1180 1180
Difficult to Remove 1110 1110
Obstruction of Flow 1035 1035
Difficult to Insert 837 837
Physical Resistance/Sticking 711 711
Activation Failure 689 689
Decrease in Pressure 652 652
Mechanical Jam 633 633
Material Deformation 610 610
Detachment of Device or Device Component 605 605
Break 587 587
Material Rupture 549 549
Failure to Advance 541 541
Failure to Fire 517 517
Product Quality Problem 416 416
Difficult to Advance 414 414
Premature Activation 363 363
Retraction Problem 340 340
Positioning Failure 325 325
Deformation Due to Compressive Stress 311 311
Misconnection 287 287
Unintended System Motion 211 211
Activation Problem 169 169
Migration 162 171
Material Split, Cut or Torn 162 162
Positioning Problem 146 146
Difficult or Delayed Activation 143 143
Component Missing 138 138
Appropriate Term/Code Not Available 135 144
Device Damaged by Another Device 130 130
Loosening of Implant Not Related to Bone-Ingrowth 121 121
Separation Failure 120 120
Failure to Cut 114 114
Firing Problem 109 109
Failure to Seal 106 106
Noise, Audible 104 104
Therapy Delivered to Incorrect Body Area 96 96
Material Twisted/Bent 95 95
Unintended Movement 83 83
Use of Device Problem 83 92
Therapeutic or Diagnostic Output Failure 79 79
Inadequate or Insufficient Training 78 78
Material Puncture/Hole 78 78
Deflation Problem 77 77
Defective Component 72 72
Burst Container or Vessel 70 70
Migration or Expulsion of Device 60 60
Difficult or Delayed Positioning 58 58
Patient-Device Incompatibility 51 51
Defective Device 48 48
No Apparent Adverse Event 42 42
Material Frayed 42 42
Leak/Splash 33 33
Crack 32 32
Mechanical Problem 31 31
Expulsion 31 31
Fracture 29 29
Image Orientation Incorrect 28 28
Difficult to Flush 28 28
Material Fragmentation 27 27
Component Misassembled 27 27
Misfire 23 23
Accessory Incompatible 21 21
Loose or Intermittent Connection 20 20
Peeled/Delaminated 20 20
Separation Problem 16 16
Unsealed Device Packaging 15 15
Output Problem 14 14
Device Dislodged or Dislocated 13 13
Contamination /Decontamination Problem 10 10
Material Integrity Problem 10 10
Stretched 10 10
Material Disintegration 9 9
Failure to Deliver 8 8
Device Damaged Prior to Use 6 6
Loss of or Failure to Bond 6 6
Device Contamination with Chemical or Other Material 6 6
Difficult to Open or Remove Packaging Material 5 5
Connection Problem 5 5
Scratched Material 5 5
Difficult or Delayed Separation 5 5
Fluid/Blood Leak 5 5
Lack of Effect 4 4
Ejection Problem 4 4
Device Markings/Labelling Problem 4 4
Human-Device Interface Problem 3 3
No Flow 3 3
Packaging Problem 3 3
Inflation Problem 3 3
Delivered as Unsterile Product 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32541 32550
No Consequences Or Impact To Patient 9469 9469
Hemorrhage/Bleeding 1153 1153
Hematoma 947 956
Obstruction/Occlusion 719 719
Insufficient Information 649 649
Blood Loss 633 633
Unspecified Tissue Injury 549 549
Pseudoaneurysm 432 441
Foreign Body In Patient 399 399
Pain 390 390
Vascular Dissection 348 348
Tissue Damage 303 303
Extravasation 266 266
Occlusion 240 240
No Known Impact Or Consequence To Patient 185 185
Thrombosis/Thrombus 172 172
No Information 169 169
Stenosis 164 164
Unspecified Infection 139 139
Swelling/ Edema 118 118
Ischemia 116 116
Low Blood Pressure/ Hypotension 106 106
Intimal Dissection 104 104
Perforation of Vessels 102 102
Thrombosis 77 77
No Patient Involvement 76 76
Diminished Pulse Pressure 72 72
Death 62 62
Device Embedded In Tissue or Plaque 60 60
No Code Available 59 59
Retroperitoneal Hemorrhage 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 63
Failure of Implant 48 48
Perforation 48 48
Fistula 47 47
Embolism/Embolus 45 45
Numbness 44 44
Inflammation 42 42
Anemia 41 41
Laceration(s) 38 47
Unspecified Vascular Problem 38 38
Stroke/CVA 34 34
Bruise/Contusion 33 33
Shock 26 26
Renal Failure 24 24
Embolism 22 22
Swelling 22 22
Calcium Deposits/Calcification 19 19
Cardiac Arrest 18 18
Aneurysm 17 17
Sepsis 17 17
Nerve Damage 15 15
Vessel Or Plaque, Device Embedded In 14 14
Discomfort 14 14
Claudication 14 14
Myocardial Infarction 13 13
Local Reaction 13 13
Fever 12 12
Post Operative Wound Infection 12 12
Hemostasis 11 11
Hypersensitivity/Allergic reaction 11 11
Abscess 11 11
Foreign Body Embolism 11 11
Thromboembolism 10 10
Loss Of Pulse 10 10
Thrombus 9 9
Rupture 9 9
Dizziness 9 9
High Blood Pressure/ Hypertension 9 9
Implant Pain 9 9
Fatigue 8 8
Rash 8 8
Skin Discoloration 8 8
Ambulation Difficulties 8 8
Loss of consciousness 7 7
Prolapse 7 7
Cardiogenic Shock 7 7
Hypovolemic Shock 7 7
Hypoxia 7 7
Ecchymosis 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Syncope/Fainting 6 6
Chest Pain 6 6
Pulmonary Embolism 6 6
Bradycardia 6 6
Nausea 6 6
Vasoconstriction 6 6
Chills 5 5
Injury 5 5
Abdominal Pain 5 5
Arrhythmia 5 5
Patient Problem/Medical Problem 5 5
Unspecified Heart Problem 5 5
Skin Infection 5 5
Easy Bruising 4 4
Test Result 4 4
Multiple Organ Failure 4 4
Bacterial Infection 4 4
Dyspnea 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Cordis US Corp II Jan-05-2024
2 TELEFLEX LLC II May-18-2023
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