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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device catheter, intravascular, diagnostic
Product CodeDQO
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ACCURATE MEDICAL THERAPEUTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
CONAVI MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 8
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS, A CARDINAL HEALTH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CLINICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 874 874
2018 777 777
2019 384 384
2020 312 312
2021 337 337
2022 232 232

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 571 571
Adverse Event Without Identified Device or Use Problem 508 508
Material Separation 484 484
Detachment of Device or Device Component 238 238
Failure to Align 231 231
Difficult to Remove 174 174
Device Contamination with Chemical or Other Material 145 145
Break 134 134
Retraction Problem 127 127
Unintended Movement 87 87
Crack 84 84
Detachment Of Device Component 79 79
Tear, Rip or Hole in Device Packaging 69 69
Occlusion Within Device 59 59
Material Puncture/Hole 54 54
Entrapment of Device 38 38
Fluid Leak 35 35
Unsealed Device Packaging 35 35
Difficult to Advance 30 30
Material Fragmentation 28 28
Material Deformation 27 27
Leak/Splash 26 26
Material Integrity Problem 25 25
Device-Device Incompatibility 24 24
Material Rupture 23 23
Device Packaging Compromised 22 22
Material Twisted/Bent 21 21
Material Split, Cut or Torn 19 19
Packaging Problem 18 18
Difficult to Insert 18 18
Separation Problem 16 16
Migration or Expulsion of Device 15 15
Delivered as Unsterile Product 15 15
Migration 13 13
Failure to Advance 13 13
Device Operates Differently Than Expected 12 12
Structural Problem 11 11
Gas Leak 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
Component Misassembled 9 9
Obstruction of Flow 9 9
Defective Device 9 9
Deformation Due to Compressive Stress 9 9
Communication or Transmission Problem 9 9
Device Contaminated During Manufacture or Shipping 8 8
Use of Device Problem 8 8
Burst Container or Vessel 8 8
Partial Blockage 7 7
Material Frayed 7 7
Unable to Obtain Readings 7 7
Activation, Positioning or SeparationProblem 7 7
Contamination /Decontamination Problem 6 6
Physical Resistance/Sticking 6 6
Positioning Problem 6 6
Hole In Material 6 6
Inflation Problem 6 6
Kinked 6 6
Air Leak 6 6
Deflation Problem 5 5
Flaked 5 5
No Display/Image 5 5
Stretched 5 5
Unraveled Material 5 5
Peeled/Delaminated 5 5
Therapeutic or Diagnostic Output Failure 5 5
Device Dislodged or Dislocated 5 5
Device Damaged by Another Device 5 5
Split 5 5
Physical Resistance 4 4
Material Perforation 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Insufficient Information 4 4
Poor Quality Image 4 4
Disconnection 4 4
Positioning Failure 4 4
Complete Blockage 4 4
Bent 3 3
Contamination 3 3
Flushing Problem 3 3
Therapy Delivered to Incorrect Body Area 3 3
Appropriate Term/Code Not Available 3 3
Torn Material 3 3
Component Missing 3 3
Improper or Incorrect Procedure or Method 3 3
Separation Failure 3 3
Device Operational Issue 3 3
Device Markings/Labelling Problem 3 3
Air/Gas in Device 3 3
Connection Problem 2 2
Calibration Problem 2 2
High Test Results 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Infusion or Flow Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Inaccurate Dispensing 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 626 626
No Clinical Signs, Symptoms or Conditions 426 426
Foreign Body In Patient 314 314
No Patient Involvement 310 310
Occlusion 305 305
Thrombosis 239 239
No Known Impact Or Consequence To Patient 213 213
Perforation of Vessels 207 207
Vessel Or Plaque, Device Embedded In 143 143
Perforation 130 130
Embolus 115 115
No Code Available 109 109
Device Embedded In Tissue or Plaque 102 102
Coagulation Disorder 81 81
Vascular Dissection 78 78
Pulmonary Embolism 72 72
Death 49 49
Pain 49 49
Swelling 48 48
Chest Pain 29 29
Insufficient Information 28 28
Stenosis 27 27
Internal Organ Perforation 27 27
Vascular System (Circulation), Impaired 26 26
No Information 24 24
Dyspnea 24 24
Hemorrhage/Bleeding 23 23
Injury 22 22
Embolism 21 21
Anxiety 18 18
Low Blood Pressure/ Hypotension 14 14
Respiratory Distress 14 14
Thrombus 13 13
Pericardial Effusion 13 13
Thrombosis/Thrombus 11 11
Vasoconstriction 11 11
Edema 11 11
Cardiac Arrest 11 11
Stroke/CVA 10 10
Hematoma 10 10
Patient Problem/Medical Problem 10 10
Cardiac Perforation 9 9
Air Embolism 9 9
Intimal Dissection 8 8
Blood Loss 8 8
Rupture 8 8
Obstruction/Occlusion 8 8
Cardiac Tamponade 7 7
Calcium Deposits/Calcification 7 7
Renal Failure 7 7
Myocardial Infarction 7 7
Abdominal Pain 6 6
Numbness 6 6
Not Applicable 6 6
Pseudoaneurysm 5 5
Thromboembolism 5 5
Coma 5 5
Intracranial Hemorrhage 5 5
Hemorrhage, Cerebral 4 4
Ischemia 4 4
Muscle Spasm(s) 4 4
Arrhythmia 4 4
Cellulitis 4 4
Depression 4 4
Ulcer 4 4
Bowel Perforation 4 4
Respiratory Failure 4 4
Aortic Dissection 4 4
Claudication 3 3
Atrial Perforation 3 3
Cardiogenic Shock 3 3
Disability 3 3
Unspecified Infection 3 3
Reocclusion 3 3
High Blood Pressure/ Hypertension 3 3
Peripheral Vascular Disease 2 2
Phlebitis 2 2
Pulmonary Edema 2 2
Seizures 2 2
Hypovolemic Shock 2 2
Congestive Heart Failure 2 2
Non specific EKG/ECG Changes 2 2
Hemoptysis 2 2
Fistula 2 2
Emotional Changes 2 2
Aneurysm 2 2
Infarction, Cerebral 2 2
Cardiopulmonary Arrest 2 2
Discomfort 2 2
Needle Stick/Puncture 2 2
Dizziness 2 2
Ventricular Fibrillation 2 2
Transient Ischemic Attack 2 2
Ulceration 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Sudden Cardiac Death 2 2
Diminished Pulse Pressure 1 1
Ascites 1 1
Radiation Exposure, Unintended 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Angiodynamics, Inc. II Feb-13-2018
3 Boston Scientific Corporation I Mar-25-2020
4 Boston Scientific Corporation II Jun-27-2017
5 Boston Scientific Corporation II Mar-23-2017
6 Cook Inc. II Nov-18-2019
7 Cordis Corporation I Sep-15-2021
8 LeMaitre Vascular, Inc. II Mar-13-2017
9 Medtronic Vascular III Sep-26-2018
10 Medtronic Vascular II Apr-20-2018
11 Numed Inc II Nov-28-2018
12 Stryker Neurovascular II Jul-15-2022
13 Vascular Solutions, Inc. I Oct-20-2020
14 Vascular Solutions, Inc. I Apr-27-2020
15 Vascular Solutions, Inc. II Feb-23-2017
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