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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
MEDICAL INGENUITIES
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  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
TZ MEDICAL INC
  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
2018 391 391
2019 393 393
2020 404 404
2021 371 371
2022 273 273
2023 128 128

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 480 480
Activation Problem 267 267
Failure to Unfold or Unwrap 129 129
Gas/Air Leak 98 98
Adverse Event Without Identified Device or Use Problem 80 80
Difficult to Open or Close 77 77
Device Operates Differently Than Expected 76 76
Break 74 74
Activation, Positioning or Separation Problem 69 69
Leak/Splash 60 60
Crack 58 58
Appropriate Term/Code Not Available 49 49
Insufficient Information 46 46
Deflation Problem 42 42
Inflation Problem 41 41
Mechanical Problem 40 40
Detachment of Device or Device Component 28 28
Material Rupture 27 27
Premature Activation 25 25
Unraveled Material 25 25
Positioning Failure 25 25
Device Contamination with Chemical or Other Material 20 20
No Apparent Adverse Event 20 20
Material Puncture/Hole 17 17
Burst Container or Vessel 16 16
Air Leak 16 16
Material Separation 15 15
Material Twisted/Bent 13 13
Fluid/Blood Leak 12 12
Device Displays Incorrect Message 10 10
Misfire 10 10
Unintended Deflation 10 10
Firing Problem 9 9
Decrease in Pressure 9 9
Defective Component 8 8
Filling Problem 8 8
Physical Resistance/Sticking 8 8
Positioning Problem 8 8
Failure to Fire 8 8
Defective Device 8 8
Failure to Cut 7 7
Structural Problem 7 7
Difficult to Insert 7 7
Migration or Expulsion of Device 7 7
Use of Device Problem 7 7
Failure to Advance 6 6
Material Deformation 6 6
Migration 6 6
Therapeutic or Diagnostic Output Failure 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Remove 5 5
Loose or Intermittent Connection 5 5
Entrapment of Device 5 5
Component Falling 5 5
Difficult to Fold, Unfold or Collapse 4 4
Device Difficult to Setup or Prepare 4 4
Peeled/Delaminated 4 4
Sticking 4 4
Component Missing 4 4
Improper or Incorrect Procedure or Method 4 4
Device Operational Issue 4 4
Pressure Problem 4 4
No Pressure 4 4
Material Split, Cut or Torn 4 4
Protective Measures Problem 3 3
Device Fell 3 3
Device Dislodged or Dislocated 3 3
Device Damaged Prior to Use 3 3
Retraction Problem 3 3
Hole In Material 3 3
Unsealed Device Packaging 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Unable to Obtain Readings 2 2
Device Expiration Issue 2 2
Infusion or Flow Problem 2 2
Mechanical Jam 2 2
Deformation Due to Compressive Stress 2 2
Activation Failure 2 2
Output Problem 2 2
Packaging Problem 2 2
Patient Device Interaction Problem 2 2
Failure to Eject 1 1
Failure to Seal 1 1
Premature Separation 1 1
Misassembled During Installation 1 1
Inaccurate Information 1 1
Unintended Movement 1 1
Noise, Audible 1 1
Audible Prompt/Feedback Problem 1 1
Incomplete or Inadequate Connection 1 1
Intermittent Communication Failure 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Battery Problem 1 1
Expiration Date Error 1 1
Failure to Align 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Physical Resistance 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 646 646
No Consequences Or Impact To Patient 597 597
No Known Impact Or Consequence To Patient 353 353
No Patient Involvement 95 95
Blood Loss 91 91
Hematoma 77 77
Hemorrhage/Bleeding 70 70
Insufficient Information 29 29
No Information 20 20
Injury 14 14
Death 11 11
No Code Available 7 7
Foreign Body In Patient 6 6
Pain 6 6
Pseudoaneurysm 5 5
Necrosis 4 4
Unspecified Infection 4 4
Hemostasis 4 4
Laceration(s) 4 4
Failure to Anastomose 3 3
Aortic Dissection 3 3
Ventricular Fibrillation 3 3
Device Embedded In Tissue or Plaque 3 3
Bruise/Contusion 3 3
Swelling/ Edema 2 2
Rupture 2 2
Cyanosis 2 2
Tissue Damage 2 2
Vascular Dissection 2 2
Failure of Implant 1 1
Respiratory Distress 1 1
Ascites 1 1
Diminished Pulse Pressure 1 1
Bradycardia 1 1
Stroke/CVA 1 1
Not Applicable 1 1
Unspecified Tissue Injury 1 1
Swelling 1 1
Thrombosis 1 1
Pallor 1 1
Multiple Organ Failure 1 1
Embolism/Embolus 1 1
Burn(s) 1 1
Numbness 1 1
Vessel Or Plaque, Device Embedded In 1 1
Air Embolism 1 1
Perforation 1 1
Blister 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
Discomfort 1 1
Cardiac Arrest 1 1
Ecchymosis 1 1
Hypoxia 1 1
Intimal Dissection 1 1
Patient Problem/Medical Problem 1 1
Low Blood Pressure/ Hypotension 1 1
Occlusion 1 1
Renal Failure 1 1
Loss of consciousness 1 1
Skin Tears 1 1
Easy Bruising 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-29-2022
2 Edwards Lifesciences, LLC I Jun-11-2019
3 Edwards Lifesciences, LLC II Apr-06-2019
4 Edwards Lifesciences, LLC II May-24-2018
5 Integra LifeSciences Corp. II Aug-30-2019
6 Merit Medical Systems, Inc. II Apr-24-2020
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