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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 clamp, vascular
Product CodeDXC
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOREP TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC
  SUBSTANTIALLY EQUIVALENT 1
COMPRESSION WORKS INC
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VACULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
KONO SEISAKUSHO CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INGENUITIES
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DIZENGENS MEDICAL SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR GRAFT SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
VASOINNOVATIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
VASOINNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 393 393
2020 404 404
2021 371 371
2022 273 273
2023 674 674
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 568 568
Activation Problem 317 317
Gas/Air Leak 269 269
Deflation Problem 195 195
Failure to Unfold or Unwrap 137 137
Difficult to Open or Close 87 87
Break 81 81
Adverse Event Without Identified Device or Use Problem 77 77
Crack 59 59
Leak/Splash 58 58
Insufficient Information 58 58
Inflation Problem 43 43
Activation, Positioning or Separation Problem 30 30
Mechanical Problem 29 29
Material Rupture 28 28
Unraveled Material 27 27
Appropriate Term/Code Not Available 24 24
Detachment of Device or Device Component 23 23
Material Puncture/Hole 23 23
Unintended Deflation 22 22
Premature Activation 21 21
No Apparent Adverse Event 20 20
Burst Container or Vessel 16 16
Material Separation 15 15
Material Twisted/Bent 11 11
Failure to Seal 11 11
Fluid/Blood Leak 10 10
Device Slipped 9 9
Defective Device 9 9
Decrease in Pressure 8 8
Migration 8 8
Filling Problem 7 7
Difficult to Insert 7 7
Failure to Cut 7 7
Therapeutic or Diagnostic Output Failure 6 6
Device Contamination with Chemical or Other Material 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 5 5
Unintended Movement 5 5
Physical Resistance/Sticking 5 5
Misfire 5 5
Failure to Fire 5 5
Use of Device Problem 5 5
Component Missing 4 4
Failure to Advance 4 4
Peeled/Delaminated 4 4
Loose or Intermittent Connection 4 4
Patient Device Interaction Problem 4 4
Material Split, Cut or Torn 3 3
Output Problem 3 3
Device Damaged Prior to Use 3 3
Short Fill 3 3
Retraction Problem 2 2
Defective Component 2 2
Device Displays Incorrect Message 2 2
Deformation Due to Compressive Stress 2 2
Communication or Transmission Problem 2 2
Unsealed Device Packaging 2 2
Migration or Expulsion of Device 2 2
Unable to Obtain Readings 2 2
Material Fragmentation 2 2
Entrapment of Device 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Mechanical Jam 2 2
No Pressure 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Fell 2 2
Activation Failure 2 2
Firing Problem 2 2
Premature Separation 1 1
Misassembled During Installation 1 1
Inaccurate Information 1 1
Noise, Audible 1 1
Audible Prompt/Feedback Problem 1 1
Incomplete or Inadequate Connection 1 1
Intermittent Communication Failure 1 1
Failure to Eject 1 1
Component Misassembled 1 1
Fail-Safe Problem 1 1
Flare or Flash 1 1
Infusion or Flow Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Fracture 1 1
Gas Output Problem 1 1
Component Incompatible 1 1
Device Alarm System 1 1
Positioning Failure 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Difficult to Remove 1 1
Product Quality Problem 1 1
Device Difficult to Setup or Prepare 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Particulates 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1061 1061
No Consequences Or Impact To Patient 553 553
Hematoma 134 134
Hemorrhage/Bleeding 121 121
No Known Impact Or Consequence To Patient 103 103
Blood Loss 69 69
Insufficient Information 67 67
No Patient Involvement 59 59
Pain 14 14
Injury 12 12
No Information 10 10
Bruise/Contusion 9 9
Death 9 9
Foreign Body In Patient 6 6
Laceration(s) 4 4
Pseudoaneurysm 4 4
Swelling/ Edema 4 4
Unspecified Infection 4 4
Ventricular Fibrillation 3 3
Cardiac Arrest 3 3
Necrosis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Code Available 3 3
Cyanosis 3 3
Diminished Pulse Pressure 2 2
Vascular Dissection 2 2
Failure of Implant 2 2
Nerve Damage 2 2
Rupture 2 2
Numbness 2 2
Air Embolism 1 1
Perforation 1 1
Blister 1 1
Needle Stick/Puncture 1 1
Discomfort 1 1
Burn, Thermal 1 1
Device Embedded In Tissue or Plaque 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1
Skin Tears 1 1
Easy Bruising 1 1
Renal Failure 1 1
Occlusion 1 1
Hypoxia 1 1
Patient Problem/Medical Problem 1 1
Intimal Dissection 1 1
Heart Failure/Congestive Heart Failure 1 1
Perforation of Vessels 1 1
Ascites 1 1
Respiratory Distress 1 1
Nervous System Injury 1 1
Tissue Damage 1 1
Unspecified Tissue Injury 1 1
Bradycardia 1 1
Multiple Organ Failure 1 1
Failure to Anastomose 1 1
Embolism/Embolus 1 1
Burn(s) 1 1
Pallor 1 1
Aortic Dissection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
2 Baxter Healthcare Corporation II Apr-29-2022
3 Edwards Lifesciences, LLC I Jun-11-2019
4 Edwards Lifesciences, LLC II Apr-06-2019
5 Integra LifeSciences Corp. II Aug-30-2019
6 Merit Medical Systems, Inc. II Apr-24-2020
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