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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
BIOREP TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  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
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRICOL BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TZ MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR GRAFT SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K203307  VIOLA
VASOINNOVATIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
VASOINNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 416 416
2018 391 391
2019 393 393
2020 404 404
2021 371 371
2022 181 181

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 424 424
Activation Problem 226 226
Device Operates Differently Than Expected 180 180
Failure to Unfold or Unwrap 115 115
Activation, Positioning or SeparationProblem 87 87
Difficult to Open or Close 79 79
Adverse Event Without Identified Device or Use Problem 78 78
Break 77 77
Gas Leak 75 75
Positioning Failure 64 64
Crack 63 63
Leak/Splash 63 63
Air Leak 56 56
Insufficient Information 51 51
Appropriate Term/Code Not Available 51 51
Inflation Problem 45 45
Mechanical Problem 34 34
Deflation Problem 32 32
Material Rupture 31 31
Device Contamination with Chemical or Other Material 31 31
Unraveled Material 26 26
Premature Activation 26 26
Detachment Of Device Component 24 24
Detachment of Device or Device Component 24 24
No Apparent Adverse Event 16 16
Failure to Advance 15 15
Misfire 15 15
Burst Container or Vessel 15 15
Migration or Expulsion of Device 15 15
Difficult to Insert 14 14
Positioning Problem 14 14
Material Twisted/Bent 13 13
Material Puncture/Hole 13 13
Material Separation 13 13
Failure to Fire 12 12
Sticking 11 11
Use of Device Problem 11 11
Fluid Leak 11 11
Device Displays Incorrect Message 10 10
Unintended Deflation 10 10
Material Deformation 9 9
Firing Problem 9 9
Decrease in Pressure 9 9
Defective Component 8 8
Filling Problem 8 8
Loss of or Failure to Bond 8 8
Physical Resistance/Sticking 8 8
Defective Device 8 8
Improper or Incorrect Procedure or Method 8 8
Failure to Cut 7 7
Structural Problem 7 7
Loose or Intermittent Connection 6 6
Entrapment of Device 6 6
Component Falling 6 6
Difficult to Remove 6 6
Component Missing 5 5
Device Operational Issue 5 5
Migration 5 5
Therapeutic or Diagnostic Output Failure 5 5
Pressure Problem 4 4
No Pressure 4 4
Material Split, Cut or Torn 4 4
Device Dislodged or Dislocated 4 4
Device Issue 4 4
Device Difficult to Setup or Prepare 4 4
Peeled/Delaminated 4 4
Difficult or Delayed Positioning 4 4
Difficult to Fold, Unfold or Collapse 4 4
Hole In Material 3 3
Delivered as Unsterile Product 3 3
Device Inoperable 3 3
Device Slipped 3 3
Device Damaged Prior to Use 3 3
Failure to Align 3 3
Malposition of Device 3 3
Device Fell 3 3
Protective Measures Problem 3 3
Unintended Movement 3 3
Mechanical Jam 3 3
Infusion or Flow Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Output Problem 2 2
Packaging Problem 2 2
Patient Device Interaction Problem 2 2
Activation Failure 2 2
Physical Resistance 2 2
Deformation Due to Compressive Stress 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Retraction Problem 2 2
Unable to Obtain Readings 2 2
Uncoiled 2 2
Fracture 2 2
Device Expiration Issue 2 2
Failure to Fold 1 1
Unintended Ejection 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Material Frayed 1 1
Gas Output Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 662 662
No Known Impact Or Consequence To Patient 583 583
No Clinical Signs, Symptoms or Conditions 464 464
Blood Loss 132 132
No Patient Involvement 113 113
Hematoma 77 77
No Information 59 59
Hemorrhage/Bleeding 55 55
Insufficient Information 23 23
No Code Available 14 14
Injury 14 14
Death 12 12
Aortic Dissection 8 8
Foreign Body In Patient 7 7
Hemostasis 7 7
Vascular Dissection 6 6
Device Embedded In Tissue or Plaque 5 5
Pseudoaneurysm 5 5
Pain 5 5
Laceration(s) 4 4
Failure to Anastomose 4 4
Swelling 2 2
Rupture 2 2
Perforation 2 2
Stroke/CVA 2 2
Tissue Damage 2 2
Ventricular Fibrillation 2 2
Patient Problem/Medical Problem 2 2
Occlusion 2 2
Swelling/ Edema 2 2
Multiple Organ Failure 1 1
Embolism/Embolus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Great Vessel Perforation 1 1
Diminished Pulse Pressure 1 1
Not Applicable 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Ascites 1 1
Numbness 1 1
Loss of consciousness 1 1
Pallor 1 1
Cyanosis 1 1
Diarrhea 1 1
Ecchymosis 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Stenosis 1 1
Discomfort 1 1
Thrombosis 1 1
Necrosis 1 1
Vessel Or Plaque, Device Embedded In 1 1
Intimal Dissection 1 1
Abdominal Pain 1 1
Air Embolism 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Ischemia 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
7 Merit Medical Systems, Inc. II Apr-10-2017
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