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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, vascular
Regulation Description Vascular clamp.
Product CodeDXC
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
AROS SURGICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
FORGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INGENUITIES
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  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
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
2016 493 493
2017 416 416
2018 391 391
2019 393 393
2020 404 404
2021 180 180

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 318 318
Fitting Problem 290 290
Activation Problem 156 156
Positioning Failure 140 140
Air Leak 121 121
Activation, Positioning or SeparationProblem 100 100
Adverse Event Without Identified Device or Use Problem 89 89
Failure to Unfold or Unwrap 82 82
Leak/Splash 76 76
Break 69 69
Gas Leak 67 67
Crack 57 57
Difficult to Open or Close 54 54
Appropriate Term/Code Not Available 52 52
Inflation Problem 47 47
Mechanical Problem 41 41
Insufficient Information 38 38
Device Contamination with Chemical or Other Material 34 34
Detachment Of Device Component 32 32
Unraveled Material 32 32
Material Rupture 32 32
Misfire 27 27
Premature Activation 25 25
Deflation Problem 24 24
Failure to Advance 23 23
Sticking 19 19
Detachment of Device or Device Component 19 19
Migration or Expulsion of Device 17 17
Positioning Problem 17 17
Failure to Fire 15 15
Burst Container or Vessel 14 14
Use of Device Problem 14 14
Material Separation 13 13
Material Twisted/Bent 13 13
Material Puncture/Hole 13 13
Difficult to Insert 13 13
Fluid Leak 12 12
Component Falling 11 11
Device Displays Incorrect Message 10 10
Material Deformation 10 10
Difficult to Remove 10 10
Defective Device 10 10
Unintended Deflation 10 10
Structural Problem 9 9
Mechanical Jam 9 9
Firing Problem 9 9
Loose or Intermittent Connection 9 9
Improper or Incorrect Procedure or Method 9 9
Decrease in Pressure 9 9
Physical Resistance/Sticking 8 8
Mechanics Altered 8 8
Defective Component 8 8
Loss of or Failure to Bond 8 8
Filling Problem 8 8
Hole In Material 7 7
Device Dislodged or Dislocated 7 7
Malposition of Device 7 7
Entrapment of Device 7 7
Peeled/Delaminated 6 6
Failure to Cut 6 6
Therapeutic or Diagnostic Output Failure 6 6
No Apparent Adverse Event 6 6
Device Operational Issue 5 5
Device Inoperable 5 5
Difficult or Delayed Positioning 5 5
Pressure Problem 5 5
Migration 4 4
Difficult to Fold, Unfold or Collapse 4 4
Device Issue 4 4
Component Missing 4 4
Device Difficult to Setup or Prepare 4 4
Retraction Problem 3 3
Fracture 3 3
Device Slipped 3 3
Physical Resistance 3 3
Computer Operating System Problem 3 3
Infusion or Flow Problem 3 3
Material Split, Cut or Torn 3 3
Kinked 3 3
Failure To Adhere Or Bond 3 3
Unable to Obtain Readings 3 3
Delivered as Unsterile Product 3 3
Unintended Movement 3 3
Manufacturing, Packaging or Shipping Problem 3 3
No Pressure 3 3
Activation Failure 2 2
Device Fell 2 2
Difficult or Delayed Activation 2 2
Material Integrity Problem 2 2
Difficult to Advance 2 2
Disconnection 2 2
Misconnection 2 2
Patient Device Interaction Problem 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 2 2
Delamination 2 2
Deformation Due to Compressive Stress 2 2
Failure to Align 2 2
Out-Of-Box Failure 2 2
Uncoiled 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 893 893
No Consequences Or Impact To Patient 759 759
Blood Loss 178 178
No Clinical Signs, Symptoms or Conditions 134 134
No Patient Involvement 125 125
No Information 83 83
Hematoma 72 72
Hemorrhage/Bleeding 36 36
No Code Available 16 16
Death 15 15
Injury 14 14
Aortic Dissection 11 11
Insufficient Information 8 8
Foreign Body In Patient 7 7
Vascular Dissection 7 7
Hemostasis 7 7
Failure to Anastomose 6 6
Device Embedded In Tissue or Plaque 5 5
Pseudoaneurysm 5 5
Patient Problem/Medical Problem 4 4
Air Embolism 4 4
Pain 4 4
Swelling 4 4
Stroke/CVA 3 3
Occlusion 3 3
Great Vessel Perforation 3 3
Skin Inflammation 3 3
Ulcer 3 3
Tissue Damage 3 3
Rupture 2 2
Perforation 2 2
Laceration(s) 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Inflammation 2 2
Ischemia 1 1
Necrosis 1 1
Diarrhea 1 1
Ecchymosis 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Thrombosis 1 1
Paresis 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Calcium Deposits/Calcification 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Vessel Or Plaque, Device Embedded In 1 1
Intimal Dissection 1 1
Abdominal Pain 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Stenosis 1 1
Ventricular Fibrillation 1 1
Weakness 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Numbness 1 1
Loss of consciousness 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Diminished Pulse Pressure 1 1
Vaso-Vagal Response 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Not Applicable 1 1
Multiple Organ Failure 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC I Jun-11-2019
2 Edwards Lifesciences, LLC II Apr-06-2019
3 Edwards Lifesciences, LLC II May-24-2018
4 Integra LifeSciences Corp. II Aug-30-2019
5 Merit Medical Systems, Inc. II Apr-24-2020
6 Merit Medical Systems, Inc. II Apr-10-2017
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