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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, tracheal, expandable
Product CodeJCT
Regulation Number 878.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
M.I. TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 122 122
2019 106 106
2020 120 120
2021 106 106
2022 61 61
2023 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 93 93
Adverse Event Without Identified Device or Use Problem 88 88
Material Deformation 79 79
Break 63 63
Positioning Problem 60 60
Activation Failure 50 50
Positioning Failure 35 35
Migration 22 22
Appropriate Term/Code Not Available 22 22
Difficult to Remove 21 21
Detachment of Device or Device Component 20 20
Use of Device Problem 18 18
Unraveled Material 17 17
Leak/Splash 17 17
Failure to Advance 16 16
Obstruction of Flow 13 13
Defective Device 13 13
Fracture 12 12
Material Separation 11 11
Material Twisted/Bent 10 10
Insufficient Information 9 9
Premature Activation 9 9
Material Rupture 9 9
Material Integrity Problem 9 9
Device Dislodged or Dislocated 8 8
Device-Device Incompatibility 8 8
Migration or Expulsion of Device 8 8
Difficult or Delayed Positioning 7 7
Difficult to Advance 7 7
Deformation Due to Compressive Stress 7 7
Human-Device Interface Problem 5 5
Mechanical Problem 5 5
Loose or Intermittent Connection 4 4
Burst Container or Vessel 4 4
Complete Blockage 4 4
Expiration Date Error 4 4
Component Missing 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Contamination 3 3
Entrapment of Device 3 3
Material Puncture/Hole 3 3
Premature Separation 3 3
Separation Problem 2 2
Device Slipped 2 2
Fluid/Blood Leak 2 2
Material Fragmentation 2 2
Inflation Problem 2 2
Failure to Capture 2 2
Difficult to Open or Close 2 2
Packaging Problem 2 2
Separation Failure 2 2
Structural Problem 2 2
Failure to Align 2 2
Failure to Fire 2 2
Wrinkled 1 1
Malposition of Device 1 1
Blocked Connection 1 1
Component or Accessory Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Device Operates Differently Than Expected 1 1
Infusion or Flow Problem 1 1
Material Protrusion/Extrusion 1 1
Collapse 1 1
Deflation Problem 1 1
Partial Blockage 1 1
Difficult to Insert 1 1
Hole In Material 1 1
Disconnection 1 1
Stretched 1 1
Unstable 1 1
Inadequacy of Device Shape and/or Size 1 1
Retraction Problem 1 1
Off-Label Use 1 1
Occlusion Within Device 1 1
Unsealed Device Packaging 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 167
No Consequences Or Impact To Patient 158 158
Blood Loss 28 28
Death 27 27
No Information 26 26
No Known Impact Or Consequence To Patient 24 24
Thrombosis 23 23
Renal Failure 21 21
Occlusion 19 19
No Code Available 17 17
Hemorrhage/Bleeding 15 15
Obstruction/Occlusion 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Insufficient Information 10 10
No Patient Involvement 10 10
Ischemia 9 9
Aneurysm 8 8
Dyspnea 7 7
Hematoma 7 7
Vascular Dissection 7 7
Thrombosis/Thrombus 6 6
Restenosis 6 6
Stenosis 5 5
Embolism 5 5
Unspecified Infection 5 5
Inflammation 5 5
Discomfort 4 4
Injury 4 4
Respiratory Failure 4 4
Pseudoaneurysm 4 4
Device Embedded In Tissue or Plaque 4 4
Foreign Body In Patient 4 4
Respiratory Insufficiency 3 3
Thrombus 3 3
Hypoxia 3 3
Pain 3 3
Perforation 3 3
Pneumothorax 3 3
Arrhythmia 3 3
Airway Obstruction 3 3
Claudication 3 3
Calcium Deposits/Calcification 2 2
Granuloma 2 2
Pulmonary Edema 2 2
Respiratory Distress 2 2
Pneumonia 2 2
Heart Failure 2 2
Unspecified Kidney or Urinary Problem 2 2
Pericardial Effusion 2 2
Foreign Body Embolism 2 2
Patient Problem/Medical Problem 2 2
Thromboembolism 2 2
Test Result 1 1
Cough 1 1
Rupture 1 1
Peritonitis 1 1
Disability 1 1
Reaction 1 1
Loss of consciousness 1 1
Respiratory Tract Infection 1 1
Jaundice 1 1
Aortic Dissection 1 1
Ischemic Heart Disease 1 1
Internal Organ Perforation 1 1
Failure of Implant 1 1
Impotence 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Abrasion 1 1
Hemoptysis 1 1
Embolus 1 1
Encephalopathy 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Anemia 1 1
Aspiration/Inhalation 1 1
Bradycardia 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation I May-18-2022
2 SPS Sterilization, Inc II Sep-13-2018
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