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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, intravascular, diagnostic
Product CodeDQO
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ACCURATE MEDICAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTL. PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOTEQUE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COLIBRI TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CONAVI MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 9
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS, A CARDINAL HEALTH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CURATIVE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
EMBOLX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENTUITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTLAB IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIGUIDE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT - KIT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRUS ENDOVASCULAR CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
OSCOR INC.
  SUBSTANTIALLY EQUIVALENT 1
PEDIACATH INC.
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX LTD
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR , LLC
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUREFIRE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 4
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CLINICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 601 601
2015 628 628
2016 614 661
2017 873 873
2018 776 776
2019 385 385
2020 312 312
2021 337 337
2022 379 379
2023 385 385
2024 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 882 882
Material Separation 819 819
Adverse Event Without Identified Device or Use Problem 658 658
Retraction Problem 457 457
Device Contamination with Chemical or Other Material 435 482
Detachment of Device or Device Component 313 313
Difficult to Remove 301 301
Break 252 252
Failure to Align 242 242
Detachment Of Device Component 211 211
Crack 152 152
Delivered as Unsterile Product 147 147
Unintended Movement 103 103
Tear, Rip or Hole in Device Packaging 98 98
Leak/Splash 83 83
Occlusion Within Device 78 78
Difficult to Advance 77 77
Material Puncture/Hole 74 74
Entrapment of Device 64 64
Packaging Problem 60 60
Fluid/Blood Leak 57 57
Air Leak 53 53
Unsealed Device Packaging 50 50
Device Packaging Compromised 48 48
Material Fragmentation 44 44
Material Deformation 41 41
Device-Device Incompatibility 39 39
Hole In Material 38 38
Material Split, Cut or Torn 38 38
Failure to Advance 38 38
Material Integrity Problem 34 34
Device Contaminated During Manufacture or Shipping 34 34
Material Rupture 33 33
Device Operates Differently Than Expected 30 30
Difficult to Insert 28 28
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Material Twisted/Bent 27 27
Kinked 25 25
Unable to Obtain Readings 23 23
Physical Resistance/Sticking 22 22
Defective Device 20 20
Insufficient Information 20 20
No Display/Image 20 20
Deformation Due to Compressive Stress 20 20
Migration or Expulsion of Device 19 19
Tip breakage 19 19
Partial Blockage 19 19
Peeled/Delaminated 18 18
Burst Container or Vessel 18 18
Communication or Transmission Problem 18 18
Material Frayed 17 17
Separation Problem 17 17
Device Damaged Prior to Use 16 16
Torn Material 15 15
Structural Problem 15 15
Gas/Air Leak 15 15
Obstruction of Flow 14 14
Deflation Problem 14 14
Use of Device Problem 14 14
Migration 13 13
Split 12 12
Stretched 12 12
Positioning Problem 11 11
Device Damaged by Another Device 11 11
Bent 11 11
Inflation Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Component Missing 10 10
Unraveled Material 10 10
Out-Of-Box Failure 10 10
Poor Quality Image 9 9
Nonstandard Device 9 9
Component Misassembled 9 9
Activation, Positioning or Separation Problem 9 9
Device Dislodged or Dislocated 8 8
Contamination /Decontamination Problem 8 8
Connection Problem 8 8
Material Perforation 8 8
Positioning Failure 8 8
Device Issue 7 7
Component(s), broken 7 7
Failure To Adhere Or Bond 7 7
Physical Resistance 7 7
Contamination 6 6
Device Displays Incorrect Message 6 6
Therapeutic or Diagnostic Output Failure 6 6
Appropriate Term/Code Not Available 6 6
Flushing Problem 6 6
Disconnection 6 6
Device Disinfection Or Sterilization Issue 6 6
Flaked 5 5
Device Markings/Labelling Problem 5 5
Material Too Soft/Flexible 5 5
Mechanical Problem 5 5
Difficult to Flush 5 5
Defective Component 5 5
Infusion or Flow Problem 5 5
Product Quality Problem 4 4
Calibration Problem 4 4
Component Falling 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1264 1264
No Clinical Signs, Symptoms or Conditions 906 906
No Known Impact Or Consequence To Patient 734 735
No Patient Involvement 558 605
Foreign Body In Patient 438 438
Occlusion 316 316
Thrombosis 305 305
Perforation of Vessels 220 220
Device Embedded In Tissue or Plaque 156 156
No Code Available 155 155
Vessel Or Plaque, Device Embedded In 142 142
Perforation 141 141
Embolus 119 119
Vascular Dissection 111 111
Coagulation Disorder 82 82
Pulmonary Embolism 81 81
Death 73 73
Pain 61 61
No Information 56 56
Insufficient Information 50 50
Swelling 50 50
Hemorrhage/Bleeding 36 36
Chest Pain 35 35
Foreign body, removal of 35 35
Injury 34 34
Stenosis 33 33
Internal Organ Perforation 29 29
Dyspnea 28 28
Embolism 28 28
Vascular System (Circulation), Impaired 27 27
Cardiac Arrest 25 25
Low Blood Pressure/ Hypotension 25 25
Thrombus 23 23
Vasoconstriction 23 23
Air Embolism 21 21
Pericardial Effusion 21 21
Thrombosis/Thrombus 20 20
Stroke/CVA 19 19
Anxiety 19 19
Intimal Dissection 18 18
Myocardial Infarction 16 16
Respiratory Distress 16 16
Arrhythmia 14 14
Patient Problem/Medical Problem 14 14
Hematoma 13 13
Blood Loss 12 12
Cardiac Perforation 11 11
Surgical procedure, additional 11 11
Edema 11 11
Obstruction/Occlusion 11 11
Cardiac Tamponade 10 10
Rupture 9 9
Renal Failure 9 9
Ventricular Fibrillation 8 8
ST Segment Elevation 8 8
Aortic Dissection 8 8
Nonresorbable materials, unretrieved in body 8 8
Calcium Deposits/Calcification 8 8
Not Applicable 8 8
Abdominal Pain 7 7
Intracranial Hemorrhage 7 7
Cardiogenic Shock 7 7
Numbness 7 7
Hemorrhage, Cerebral 6 6
Ischemia 6 6
Pseudoaneurysm 6 6
Claudication 5 5
Thromboembolism 5 5
Unspecified Infection 5 5
Fever 5 5
Bradycardia 5 5
Coma 5 5
Other (for use when an appropriate patient code cannot be identified) 5 5
Ulcer 5 5
Dizziness 4 4
Depression 4 4
Pneumothorax 4 4
Paresis 4 4
Tachycardia 4 4
Tissue Damage 4 4
Cellulitis 4 4
Aneurysm 4 4
High Blood Pressure/ Hypertension 4 4
Hemorrhage, Subarachnoid 4 4
Muscle Spasm(s) 4 4
Bowel Perforation 4 4
Respiratory Failure 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Atrial Perforation 3 3
Ischemia Stroke 3 3
Muscle Weakness 3 3
Laceration(s) 3 3
Nausea 3 3
Reocclusion 3 3
Hemoptysis 3 3
Encephalopathy 3 3
Angina 3 3
Infarction, Cerebral 3 3
Cardiopulmonary Arrest 3 3
Phlebitis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Angiodynamics Worldwide Headquarters II Aug-09-2012
3 Angiodynamics Worldwide Headquarters II Sep-16-2011
4 Angiodynamics, Inc. II Feb-13-2018
5 Arrow International Inc II Nov-02-2016
6 B. Braun Medical, Inc. II May-20-2016
7 Boston Scientific Corporation I Mar-25-2020
8 Boston Scientific Corporation II Jun-27-2017
9 Boston Scientific Corporation II Mar-23-2017
10 Boston Scientific Corporation II Apr-11-2012
11 Boston Scientific Corporation I Jun-10-2011
12 Boston Scientific Corporation II Jan-21-2010
13 Boston Scientific Corporation II Sep-04-2009
14 Cook Inc. II Nov-18-2019
15 Cook Inc. II Aug-22-2016
16 Cook Inc. I Feb-24-2016
17 Cook Inc. I Aug-05-2015
18 Cordis Corporation I Sep-15-2021
19 Cordis Corporation II Nov-17-2011
20 Cordis US Corp I Nov-09-2023
21 Cordis US Corp II Dec-16-2022
22 Edwards Lifesciences, LLC II Aug-12-2012
23 ICU Medical, Inc. II Oct-11-2012
24 ICU Medical, Inc. II Aug-02-2012
25 LeMaitre Vascular, Inc. II Mar-13-2017
26 Medtronic Vascular III Sep-26-2018
27 Medtronic Vascular II Apr-20-2018
28 Merit Medical Systems, Inc. II Oct-22-2013
29 Merit Medical Systems, Inc. II May-25-2013
30 Merit Medical Systems, Inc. II Dec-08-2010
31 Merit Medical Systems, Inc. II May-28-2010
32 Merit Medical Systems, Inc. II Dec-14-2009
33 Merit Medical Systems, Inc. III Jan-13-2009
34 Millar Instruments, Inc I Mar-24-2011
35 Millar Instruments, Inc II Nov-17-2010
36 Numed Inc II Nov-28-2018
37 Siemens Medical Solutions USA, Inc. II Mar-23-2011
38 Stryker Neurovascular II Jul-15-2022
39 Stryker Sustainability Solutions I Jul-22-2016
40 Stryker, Inc. II Feb-14-2024
41 Vascular Solutions, Inc. I Oct-20-2020
42 Vascular Solutions, Inc. I Apr-27-2020
43 Vascular Solutions, Inc. II Feb-23-2017
44 Vascular Solutions, Inc. I Oct-20-2016
45 Vascular Solutions, Inc. I Jul-03-2014
46 Vascular Solutions, Inc. II Jul-11-2011
47 Vascular Solutions, Inc. II Sep-28-2010
48 Volcano Corporation II Sep-12-2014
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