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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 9
  SUBSTANTIALLY EQUIVALENT - KIT 1
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 4
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 391 391
2024 318 318

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 911 911
Material Separation 849 849
Adverse Event Without Identified Device or Use Problem 682 682
Retraction Problem 457 457
Device Contamination with Chemical or Other Material 441 488
Detachment of Device or Device Component 339 339
Difficult to Remove 321 321
Break 263 263
Failure to Align 242 242
Detachment Of Device Component 211 211
Crack 178 178
Delivered as Unsterile Product 147 147
Tear, Rip or Hole in Device Packaging 104 104
Unintended Movement 103 103
Leak/Splash 86 86
Difficult to Advance 85 85
Material Puncture/Hole 81 81
Occlusion Within Device 78 78
Fluid/Blood Leak 77 77
Entrapment of Device 64 64
Packaging Problem 60 60
Air Leak 53 53
Unsealed Device Packaging 51 51
Device Packaging Compromised 48 48
Material Split, Cut or Torn 47 47
Material Fragmentation 47 47
Material Deformation 43 43
Device-Device Incompatibility 40 40
Failure to Advance 40 40
Hole In Material 38 38
Material Integrity Problem 35 35
Device Contaminated During Manufacture or Shipping 34 34
Material Rupture 33 33
Material Twisted/Bent 30 30
Device Operates Differently Than Expected 30 30
Difficult to Insert 28 28
Physical Resistance/Sticking 27 27
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Kinked 25 25
Unable to Obtain Readings 23 23
No Display/Image 23 23
Deformation Due to Compressive Stress 23 23
Defective Device 21 21
Material Frayed 21 21
Peeled/Delaminated 20 20
Insufficient Information 20 20
Migration or Expulsion of Device 19 19
Partial Blockage 19 19
Tip breakage 19 19
Gas/Air Leak 18 18

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 1057 1057
No Known Impact Or Consequence To Patient 734 735
No Patient Involvement 558 605
Foreign Body In Patient 461 461
Occlusion 316 316
Thrombosis 305 305
Perforation of Vessels 220 220
Device Embedded In Tissue or Plaque 159 159
No Code Available 155 155
Vessel Or Plaque, Device Embedded In 142 142
Perforation 142 142
Embolus 119 119
Vascular Dissection 113 113
Coagulation Disorder 82 82
Pulmonary Embolism 81 81
Death 73 73
Pain 62 62
No Information 56 56
Insufficient Information 55 55
Swelling 50 50
Hemorrhage/Bleeding 37 37
Foreign body, removal of 35 35
Chest Pain 35 35
Injury 34 34
Stenosis 33 33
Internal Organ Perforation 29 29
Dyspnea 28 28
Embolism 28 28
Vasoconstriction 27 27
Vascular System (Circulation), Impaired 27 27
Low Blood Pressure/ Hypotension 25 25
Cardiac Arrest 25 25
Thrombus 23 23
Stroke/CVA 23 23
Thrombosis/Thrombus 23 23
Air Embolism 23 23
Pericardial Effusion 22 22
Anxiety 19 19
Obstruction/Occlusion 18 18
Intimal Dissection 18 18
Respiratory Distress 16 16
Myocardial Infarction 16 16
Arrhythmia 14 14
Patient Problem/Medical Problem 14 14
Hematoma 13 13
Blood Loss 12 12
Surgical procedure, additional 11 11
Cardiac Perforation 11 11
Edema 11 11

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