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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)
2019 2020 2021 2022 2023 2024
27 10 17 11 18 21

MDR Year MDR Reports MDR Events
2019 6156 6156
2020 5927 5927
2021 7586 7586
2022 9457 9466
2023 13529 13529
2024 12440 12440

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 27990 27990
Material Separation 6223 6223
Malposition of Device 2481 2481
Improper or Incorrect Procedure or Method 2328 2328
Adverse Event Without Identified Device or Use Problem 1639 1639
Insufficient Information 1610 1610
Off-Label Use 1501 1501
Patient Device Interaction Problem 1498 1498
Activation, Positioning or Separation Problem 1461 1461
Entrapment of Device 1360 1360
Difficult to Open or Close 1350 1350
Difficult to Remove 1224 1224
Obstruction of Flow 1123 1123
Difficult to Insert 904 904
Activation Failure 761 761
Decrease in Pressure 753 753
Physical Resistance/Sticking 748 748
Mechanical Jam 700 700
Material Rupture 649 649
Material Deformation 635 635
Break 625 625
Failure to Fire 624 624
Detachment of Device or Device Component 621 621
Failure to Advance 603 603
Difficult to Advance 489 489
Premature Activation 452 452
Product Quality Problem 450 450
Retraction Problem 359 359
Deformation Due to Compressive Stress 337 337
Positioning Failure 331 331
Misconnection 290 290
Activation Problem 232 232
Unintended System Motion 221 221
Migration 206 215
Loosening of Implant Not Related to Bone-Ingrowth 179 179
Material Split, Cut or Torn 170 170
Positioning Problem 152 152
Difficult or Delayed Activation 151 151
Component Missing 148 148
Device Damaged by Another Device 142 142
Appropriate Term/Code Not Available 135 144
Failure to Seal 134 134
Separation Failure 127 127
Defective Component 125 125
Failure to Cut 119 119
Noise, Audible 116 116
Firing Problem 110 110
Therapy Delivered to Incorrect Body Area 110 110
Material Puncture/Hole 98 98
Material Twisted/Bent 97 97

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38619 38628
No Consequences Or Impact To Patient 9469 9469
Hemorrhage/Bleeding 1298 1298
Hematoma 1020 1029
Obstruction/Occlusion 809 809
Insufficient Information 684 684
Blood Loss 633 633
Unspecified Tissue Injury 632 632
Pseudoaneurysm 495 504
Foreign Body In Patient 444 444
Pain 420 420
Vascular Dissection 380 380
Tissue Damage 303 303
Extravasation 271 271
Occlusion 240 240
Thrombosis/Thrombus 198 198
No Known Impact Or Consequence To Patient 185 185
Stenosis 171 171
No Information 169 169
Unspecified Infection 159 159
Ischemia 131 131
Swelling/ Edema 125 125
Low Blood Pressure/ Hypotension 114 114
Perforation of Vessels 113 113
Intimal Dissection 104 104
Diminished Pulse Pressure 81 81
Thrombosis 77 77
No Patient Involvement 76 76
Death 62 62
Retroperitoneal Hemorrhage 61 61
Device Embedded In Tissue or Plaque 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 68
No Code Available 59 59
Failure of Implant 56 56
Fistula 48 48
Perforation 48 48
Embolism/Embolus 48 48
Unspecified Vascular Problem 48 48
Numbness 46 46
Inflammation 45 45
Anemia 42 42
Laceration(s) 42 51
Local Reaction 38 38
Bruise/Contusion 35 35
Stroke/CVA 35 35
Shock 27 27
Renal Failure 24 24
Embolism 22 22
Swelling 22 22
Aneurysm 22 22

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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