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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 156 156

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 598 598
Activation Problem 329 329
Gas/Air Leak 281 281
Deflation Problem 209 209
Failure to Unfold or Unwrap 145 145
Difficult to Open or Close 93 93
Adverse Event Without Identified Device or Use Problem 90 90
Break 89 89
Crack 61 61
Leak/Splash 61 61
Insufficient Information 58 58
Inflation Problem 46 46
Mechanical Problem 31 31
Activation, Positioning or Separation Problem 30 30
Material Rupture 29 29
Unraveled Material 27 27
Detachment of Device or Device Component 25 25
Appropriate Term/Code Not Available 24 24
No Apparent Adverse Event 23 23
Unintended Deflation 23 23
Material Puncture/Hole 23 23
Premature Activation 22 22
Burst Container or Vessel 16 16
Material Separation 15 15
Failure to Seal 12 12
Material Twisted/Bent 12 12
Fluid/Blood Leak 10 10
Filling Problem 9 9
Device Slipped 9 9
Defective Device 9 9
Migration 9 9
Decrease in Pressure 8 8
Difficult to Insert 7 7
Failure to Cut 7 7
Device Contamination with Chemical or Other Material 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Therapeutic or Diagnostic Output Failure 6 6
Delivered as Unsterile Product 6 6
Use of Device Problem 6 6
Component Missing 5 5
Misfire 5 5
Failure to Fire 5 5
Unintended Movement 5 5
Physical Resistance/Sticking 5 5
Material Deformation 5 5
Material Split, Cut or Torn 4 4
Patient Device Interaction Problem 4 4
Failure to Advance 4 4
Loose or Intermittent Connection 4 4
Peeled/Delaminated 4 4
Device Damaged Prior to Use 3 3
Deformation Due to Compressive Stress 3 3
Short Fill 3 3
Device Contaminated During Manufacture or Shipping 3 3
Output Problem 3 3
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
Activation Failure 2 2
Device Fell 2 2
Firing Problem 2 2
Retraction Problem 2 2
Communication or Transmission Problem 2 2
Defective Component 2 2
Device Displays Incorrect Message 2 2
Unable to Obtain Readings 2 2
Migration or Expulsion of Device 2 2
Unsealed Device Packaging 2 2
Fracture 2 2
Material Fragmentation 2 2
Electrical /Electronic Property Problem 2 2
Entrapment of Device 2 2
Difficult to Fold, Unfold or Collapse 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
Particulates 1 1
No Device Output 1 1
Incorrect Measurement 1 1
Difficult to Remove 1 1
Product Quality Problem 1 1
Device Difficult to Setup or Prepare 1 1
Separation Failure 1 1
Expiration Date Error 1 1
Connection Problem 1 1
Contamination /Decontamination Problem 1 1
Battery Problem 1 1
Shipping Damage or Problem 1 1
Unexpected Therapeutic Results 1 1
Incomplete or Missing Packaging 1 1
Structural Problem 1 1
Failure to Align 1 1
Failure to Zero 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1156 1156
No Consequences Or Impact To Patient 553 553
Hematoma 148 148
Hemorrhage/Bleeding 137 137
No Known Impact Or Consequence To Patient 103 103
Insufficient Information 70 70
Blood Loss 69 69
No Patient Involvement 59 59
Pain 14 14
Injury 12 12
No Information 10 10
Death 9 9
Bruise/Contusion 9 9
Foreign Body In Patient 7 7
Pseudoaneurysm 6 6
Swelling/ Edema 5 5
Laceration(s) 5 5
Unspecified Infection 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Vascular Dissection 3 3
Necrosis 3 3
Cardiac Arrest 3 3
Cyanosis 3 3
Ventricular Fibrillation 3 3
Failure of Implant 2 2
Numbness 2 2
Nerve Damage 2 2
Thrombosis/Thrombus 2 2
Diminished Pulse Pressure 2 2
Rupture 2 2
Unspecified Heart Problem 2 2
Blister 1 1
Easy Bruising 1 1
Unspecified Tissue Injury 1 1
Discomfort 1 1
Patient Problem/Medical Problem 1 1
Nervous System Injury 1 1
Heart Failure/Congestive Heart Failure 1 1
Device Embedded In Tissue or Plaque 1 1
Multiple Organ Failure 1 1
Embolism/Embolus 1 1
Occlusion 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Burn(s) 1 1
Failure to Anastomose 1 1
Intimal Dissection 1 1
Air Embolism 1 1
Bradycardia 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Pallor 1 1
Aortic Dissection 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Ascites 1 1
Perforation of Vessels 1 1
Perforation 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-12-2024
2 Baxter Healthcare Corporation II Jan-05-2024
3 Baxter Healthcare Corporation II Apr-29-2022
4 Edwards Lifesciences, LLC I Jun-11-2019
5 Edwards Lifesciences, LLC II Apr-06-2019
6 Integra LifeSciences Corp. II Aug-30-2019
7 Merit Medical Systems, Inc. II Apr-24-2020
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