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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
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 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 404 404
Activation Problem 216 216
Device Operates Differently Than Expected 180 180
Failure to Unfold or Unwrap 109 109
Activation, Positioning or SeparationProblem 87 87
Adverse Event Without Identified Device or Use Problem 77 77
Difficult to Open or Close 76 76
Gas Leak 75 75
Break 73 73
Positioning Failure 64 64
Leak/Splash 63 63
Crack 60 60
Air Leak 56 56
Appropriate Term/Code Not Available 51 51
Insufficient Information 47 47
Inflation Problem 45 45
Mechanical Problem 33 33
Deflation Problem 32 32
Material Rupture 31 31
Device Contamination with Chemical or Other Material 30 30
Unraveled Material 26 26
Premature Activation 25 25
Detachment of Device or Device Component 24 24
Detachment Of Device Component 24 24
No Apparent Adverse Event 16 16
Failure to Advance 15 15
Migration or Expulsion of Device 15 15
Burst Container or Vessel 15 15
Misfire 14 14
Difficult to Insert 14 14
Positioning Problem 14 14
Material Puncture/Hole 13 13
Material Separation 13 13
Material Twisted/Bent 13 13
Sticking 11 11
Use of Device Problem 11 11
Fluid Leak 11 11
Unintended Deflation 10 10
Device Displays Incorrect Message 10 10
Failure to Fire 10 10
Material Deformation 9 9
Decrease in Pressure 9 9
Firing Problem 9 9
Loss of or Failure to Bond 8 8
Filling Problem 8 8
Defective Device 8 8
Defective Component 8 8
Improper or Incorrect Procedure or Method 8 8
Physical Resistance/Sticking 8 8
Failure to Cut 7 7
Structural Problem 7 7
Loose or Intermittent Connection 6 6
Component Falling 6 6
Entrapment of Device 6 6
Difficult to Remove 6 6
Device Operational Issue 5 5
Migration 5 5
Component Missing 5 5
Therapeutic or Diagnostic Output Failure 5 5
Device Dislodged or Dislocated 4 4
Device Difficult to Setup or Prepare 4 4
Difficult or Delayed Positioning 4 4
Pressure Problem 4 4
Difficult to Fold, Unfold or Collapse 4 4
Peeled/Delaminated 4 4
Device Issue 4 4
Hole In Material 3 3
Infusion or Flow Problem 3 3
Mechanical Jam 3 3
Protective Measures Problem 3 3
Device Inoperable 3 3
Unintended Movement 3 3
No Pressure 3 3
Device Fell 3 3
Delivered as Unsterile Product 3 3
Malposition of Device 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Slipped 3 3
Failure to Align 3 3
Material Split, Cut or Torn 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Retraction Problem 2 2
Deformation Due to Compressive Stress 2 2
Output Problem 2 2
Packaging Problem 2 2
Device Expiration Issue 2 2
Activation Failure 2 2
Unable to Obtain Readings 2 2
Patient Device Interaction Problem 2 2
Physical Resistance 2 2
Uncoiled 2 2
Fracture 2 2
Unsealed Device Packaging 1 1
Complete Blockage 1 1
Component Incompatible 1 1
Bent 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Expiration Date Error 1 1
Separation Failure 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 417 417
Blood Loss 132 132
No Patient Involvement 113 113
Hematoma 77 77
No Information 59 59
Hemorrhage/Bleeding 50 50
Insufficient Information 21 21
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
Perforation 2 2
Rupture 2 2
Stroke/CVA 2 2
Occlusion 2 2
Swelling 2 2
Tissue Damage 2 2
Ventricular Fibrillation 2 2
Patient Problem/Medical Problem 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Multiple Organ Failure 1 1
Embolism/Embolus 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
Thrombosis 1 1
Stenosis 1 1
Discomfort 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Necrosis 1 1
Diarrhea 1 1
Ecchymosis 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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