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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
PFM MEDICAL, 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 385 385
2020 312 312
2021 337 337
2022 315 315

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 603 603
Adverse Event Without Identified Device or Use Problem 518 518
Material Separation 516 516
Detachment of Device or Device Component 241 241
Failure to Align 232 232
Difficult to Remove 183 183
Device Contamination with Chemical or Other Material 146 146
Break 141 141
Retraction Problem 127 127
Crack 87 87
Unintended Movement 87 87
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/Blood Leak 36 36
Difficult to Advance 36 36
Unsealed Device Packaging 35 35
Material Deformation 30 30
Material Fragmentation 29 29
Device-Device Incompatibility 27 27
Material Integrity Problem 26 26
Material Twisted/Bent 26 26
Leak/Splash 26 26
Material Rupture 25 25
Material Split, Cut or Torn 23 23
Device Packaging Compromised 22 22
Packaging Problem 18 18
Difficult to Insert 18 18
Failure to Advance 16 16
Separation Problem 16 16
Migration or Expulsion of Device 15 15
Delivered as Unsterile Product 15 15
Migration 13 13
Device Operates Differently Than Expected 12 12
Communication or Transmission Problem 12 12
Deformation Due to Compressive Stress 11 11
Structural Problem 11 11
Gas/Air Leak 11 11
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Use of Device Problem 9 9
Component Misassembled 9 9
Obstruction of Flow 9 9
Defective Device 9 9
Physical Resistance/Sticking 9 9
Device Contaminated During Manufacture or Shipping 8 8
Burst Container or Vessel 8 8
Partial Blockage 7 7
Material Frayed 7 7
Inflation Problem 7 7
Unable to Obtain Readings 7 7
Activation, Positioning or Separation Problem 7 7
Contamination /Decontamination Problem 6 6
Unraveled Material 6 6
Positioning Problem 6 6
Kinked 6 6
Peeled/Delaminated 6 6
Hole In Material 6 6
No Display/Image 6 6
Air Leak 6 6
Deflation Problem 5 5
Flaked 5 5
Poor Quality Image 5 5
Stretched 5 5
Therapeutic or Diagnostic Output Failure 5 5
Device Dislodged or Dislocated 5 5
Split 5 5
Device Damaged by Another Device 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
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
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Torn Material 3 3
Component Missing 3 3
Separation Failure 3 3
Improper or Incorrect Procedure or Method 3 3
Calibration Problem 3 3
Device Operational Issue 3 3
Device Markings/Labelling Problem 3 3
Air/Gas in Device 3 3
Infusion or Flow Problem 2 2
Connection Problem 2 2
High Test Results 2 2
Output Problem 2 2
Material Too Soft/Flexible 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping 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 481 481
Foreign Body In Patient 323 323
No Patient Involvement 310 310
Occlusion 305 305
Thrombosis 239 239
No Known Impact Or Consequence To Patient 213 213
Perforation of Vessels 208 208
Vessel Or Plaque, Device Embedded In 143 143
Perforation 131 131
Embolus 115 115
No Code Available 109 109
Device Embedded In Tissue or Plaque 104 104
Vascular Dissection 81 81
Coagulation Disorder 81 81
Pulmonary Embolism 72 72
Pain 50 50
Death 49 49
Swelling 48 48
Insufficient Information 33 33
Chest Pain 30 30
Internal Organ Perforation 28 28
Stenosis 27 27
Vascular System (Circulation), Impaired 26 26
Hemorrhage/Bleeding 24 24
Dyspnea 24 24
No Information 24 24
Injury 22 22
Embolism 21 21
Anxiety 18 18
Low Blood Pressure/ Hypotension 17 17
Stroke/CVA 15 15
Respiratory Distress 14 14
Thrombus 13 13
Thrombosis/Thrombus 13 13
Pericardial Effusion 13 13
Vasoconstriction 12 12
Cardiac Arrest 12 12
Edema 11 11
Hematoma 10 10
Patient Problem/Medical Problem 10 10
Cardiac Perforation 10 10
Obstruction/Occlusion 9 9
Rupture 9 9
Air Embolism 9 9
Intimal Dissection 8 8
Cardiac Tamponade 8 8
Blood Loss 8 8
Renal Failure 7 7
Calcium Deposits/Calcification 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
Brain Injury 3 3
Disability 3 3
Cardiogenic Shock 3 3
Hemoptysis 3 3
Muscle Weakness 3 3
High Blood Pressure/ Hypertension 3 3
Unspecified Infection 3 3
Reocclusion 3 3
Peripheral Vascular Disease 2 2
Phlebitis 2 2
Seizures 2 2
Pulmonary Edema 2 2
Memory Loss/Impairment 2 2
Hypovolemic Shock 2 2
Fistula 2 2
Emotional Changes 2 2
Congestive Heart Failure 2 2
Non specific EKG/ECG Changes 2 2
Aneurysm 2 2
Angina 2 2
Cardiopulmonary Arrest 2 2
Infarction, Cerebral 2 2
Discomfort 2 2
Dizziness 2 2
Ventricular Fibrillation 2 2
Loss of Vision 2 2
Transient Ischemic Attack 2 2
Ulceration 2 2
Needle Stick/Puncture 2 2
Sudden Cardiac Death 2 2

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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