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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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Device catheter, intravascular, diagnostic
Regulation Description Diagnostic intravascular catheter.
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 9
CORDIS, A CARDINAL HEALTH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT - KIT 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 1
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 614 661
2017 874 874
2018 780 780
2019 384 384
2020 312 312
2021 231 231

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 544 544
Fracture 495 495
Material Separation 387 387
Device Contamination with Chemical or Other Material 246 293
Failure to Align 241 241
Detachment of Device or Device Component 206 206
Retraction Problem 192 192
Difficult to Remove 167 167
Break 141 141
Detachment Of Device Component 126 126
Unintended Movement 99 99
Crack 91 91
Tear, Rip or Hole in Device Packaging 80 80
Occlusion Within Device 75 75
Delivered as Unsterile Product 46 46
Unsealed Device Packaging 43 43
Material Puncture/Hole 41 41
Packaging Problem 41 41
Leak/Splash 38 38
Entrapment of Device 38 38
Device Packaging Compromised 35 35
Fluid Leak 33 33
Material Fragmentation 31 31
Air Leak 27 27
Material Rupture 23 23
Device-Device Incompatibility 23 23
Difficult to Advance 23 23
Material Integrity Problem 21 21
Material Deformation 20 20
Migration or Expulsion of Device 18 18
Material Twisted/Bent 17 17
Device Operates Differently Than Expected 17 17
Difficult to Insert 16 16
Separation Problem 15 15
Material Split, Cut or Torn 14 14
Insufficient Information 13 13
Burst Container or Vessel 12 12
Hole In Material 12 12
Kinked 12 12
Partial Blockage 12 12
Incorrect, Inadequate or Imprecise Resultor Readings 11 11
Structural Problem 11 11
Defective Device 9 9
Material Frayed 8 8
Failure to Advance 8 8
Device Damaged Prior to Use 7 7
Migration 7 7
Unable to Obtain Readings 7 7
Obstruction of Flow 7 7
Inflation Problem 7 7
Positioning Failure 6 6
Use of Device Problem 6 6
Material Perforation 6 6
Split 6 6
Device Issue 6 6
Deformation Due to Compressive Stress 6 6
Communication or Transmission Problem 6 6
Gas Leak 6 6
Activation, Positioning or SeparationProblem 6 6
Unraveled Material 6 6
Positioning Problem 6 6
Contamination /Decontamination Problem 6 6
Defective Component 5 5
Device Contaminated During Manufacture or Shipping 5 5
Disconnection 5 5
Device Dislodged or Dislocated 5 5
Physical Resistance 5 5
Deflation Problem 5 5
Complete Blockage 4 4
Bent 4 4
Flushing Problem 4 4
Torn Material 4 4
Flaked 4 4
Peeled/Delaminated 4 4
Component Misassembled 4 4
Physical Resistance/Sticking 4 4
Air/Gas in Device 3 3
Connection Problem 3 3
Device Markings/Labelling Problem 3 3
Therapy Delivered to Incorrect Body Area 3 3
Improper or Incorrect Procedure or Method 3 3
Failure To Adhere Or Bond 3 3
Appropriate Term/Code Not Available 3 3
Component Missing 3 3
Problem with Sterilization 3 3
Stretched 3 3
Device Operational Issue 3 3
Device Damaged by Another Device 3 3
Expulsion 3 3
Delamination 3 3
Infusion or Flow Problem 3 3
Improper Flow or Infusion 2 2
Inaccurate Dispensing 2 2
Output Problem 2 2
No Display/Image 2 2
Misassembly by Users 2 2
No Apparent Adverse Event 2 2
Noise, Audible 2 2
Contamination 2 2
Fitting Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 811 811
No Patient Involvement 444 491
No Known Impact Or Consequence To Patient 341 341
Occlusion 314 314
Foreign Body In Patient 279 279
Thrombosis 277 277
Perforation of Vessels 200 200
No Clinical Signs, Symptoms or Conditions 197 197
Vessel Or Plaque, Device Embedded In 143 143
Perforation 137 137
Device Embedded In Tissue or Plaque 125 125
No Code Available 124 124
Embolus 118 118
Coagulation Disorder 80 80
Pulmonary Embolism 79 79
Vascular Dissection 61 61
Death 58 58
Pain 53 53
Swelling 49 49
No Information 36 36
Injury 32 32
Chest Pain 28 28
Embolism 27 27
Stenosis 26 26
Vascular System (Circulation), Impaired 26 26
Internal Organ Perforation 25 25
Dyspnea 24 24
Thrombus 23 23
Hemorrhage/Bleeding 23 23
Anxiety 19 19
Low Blood Pressure/ Hypotension 16 16
Pericardial Effusion 16 16
Respiratory Distress 15 15
Myocardial Infarction 14 14
Insufficient Information 14 14
Intimal Dissection 12 12
Cardiac Arrest 12 12
Patient Problem/Medical Problem 12 12
Edema 11 11
Air Embolism 10 10
Vasoconstriction 9 9
Cardiac Perforation 9 9
Blood Loss 9 9
Not Applicable 8 8
Thrombosis/Thrombus 8 8
Cardiac Tamponade 8 8
Renal Failure 7 7
Hematoma 7 7
Stroke/CVA 7 7
Abdominal Pain 6 6
Calcium Deposits/Calcification 6 6
ST Segment Elevation 6 6
Numbness 6 6
Coma 5 5
Ulcer 5 5
Rupture 5 5
Intracranial Hemorrhage 5 5
Muscle Spasm(s) 4 4
Hemorrhage, Cerebral 4 4
Fever 4 4
Respiratory Failure 4 4
Aortic Dissection 4 4
Claudication 4 4
Bowel Perforation 4 4
Cellulitis 4 4
Pseudoaneurysm 4 4
Depression 4 4
Disability 3 3
Obstruction/Occlusion 3 3
Arrhythmia 3 3
Bradycardia 3 3
Unspecified Infection 3 3
Reocclusion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Atrial Perforation 3 3
Aneurysm 3 3
Ischemia 3 3
High Blood Pressure/ Hypertension 3 3
Transient Ischemic Attack 2 2
Ulceration 2 2
Cardiopulmonary Arrest 2 2
Congestive Heart Failure 2 2
Emotional Changes 2 2
Hypovolemic Shock 2 2
Sudden Cardiac Death 2 2
Pulmonary Edema 2 2
Peripheral Vascular Disease 2 2
Phlebitis 2 2
Hemoptysis 2 2
Hemorrhage, Subarachnoid 2 2
Infarction, Cerebral 2 2
Needle Stick/Puncture 2 2
Radiation Exposure, Unintended 2 2
Thromboembolism 2 2
Cardiogenic Shock 2 2
Discomfort 2 2
Seizures 2 2
Dizziness 2 2
Heart Failure 1 1
Brain Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Feb-13-2018
2 Arrow International Inc II Nov-02-2016
3 B. Braun Medical, Inc. II May-20-2016
4 Boston Scientific Corporation I Mar-25-2020
5 Boston Scientific Corporation II Jun-27-2017
6 Boston Scientific Corporation II Mar-23-2017
7 Cook Inc. II Nov-18-2019
8 Cook Inc. II Aug-22-2016
9 Cook Inc. I Feb-24-2016
10 Cordis Corporation I Sep-15-2021
11 LeMaitre Vascular, Inc. II Mar-13-2017
12 Medtronic Vascular III Sep-26-2018
13 Medtronic Vascular II Apr-20-2018
14 Numed Inc II Nov-28-2018
15 Stryker Sustainability Solutions I Jul-22-2016
16 Vascular Solutions, Inc. I Oct-20-2020
17 Vascular Solutions, Inc. I Apr-27-2020
18 Vascular Solutions, Inc. II Feb-23-2017
19 Vascular Solutions, Inc. I Oct-20-2016
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