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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, guide, catheter
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 5
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 16
ASAHI INTECC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO COPORATION
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIVANT LIMITED (LAKE REGION MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 10
EMBRACE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMEC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC CORE VALVE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2
OPSENS
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 3
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA CARDIO ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 3
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
TATARA VASCULAR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 1463 1463
2017 1523 1523
2018 1736 1736
2019 1677 1677
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 2069 2069
2024 1468 1468

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1931 2907
Difficult to Remove 1896 1896
Break 1660 1660
Fracture 1301 1301
Detachment of Device or Device Component 1281 1281
Peeled/Delaminated 1221 1221
Adverse Event Without Identified Device or Use Problem 1112 1234
Difficult to Advance 982 982
Entrapment of Device 903 1879
Detachment Of Device Component 893 893
Failure to Advance 640 640
Stretched 554 554
Material Deformation 520 520
Unraveled Material 470 470
Material Integrity Problem 430 430
Deformation Due to Compressive Stress 417 417
Improper or Incorrect Procedure or Method 376 376
Physical Resistance/Sticking 345 345
Material Split, Cut or Torn 298 298
Insufficient Information 282 282
Material Twisted/Bent 259 259
Difficult To Position 162 162
Flaked 158 158
Material Fragmentation 154 154
Device Damaged by Another Device 152 152
Positioning Problem 140 140
Product Quality Problem 136 136
Kinked 135 135
Material Frayed 132 132
Physical Resistance 101 101
Material Protrusion/Extrusion 100 100
Off-Label Use 94 94
Device Operates Differently Than Expected 80 80
Difficult to Insert 65 65
Fluid/Blood Leak 63 63
Device Damaged Prior to Use 63 63
Contamination /Decontamination Problem 63 63
Material Too Soft/Flexible 61 61
Device Contamination with Chemical or Other Material 53 53
Use of Device Problem 52 52
Device Contaminated During Manufacture or Shipping 51 51
Device Dislodged or Dislocated 50 50
Defective Device 49 49
Unsealed Device Packaging 48 48
Component Misassembled 47 47
Activation, Positioning or Separation Problem 46 46
Bent 44 44
Leak/Splash 39 39
Appropriate Term/Code Not Available 38 38
Occlusion Within Device 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4300 5398
No Consequences Or Impact To Patient 3705 3705
Foreign Body In Patient 1574 1574
Device Embedded In Tissue or Plaque 1237 1237
No Known Impact Or Consequence To Patient 1019 1507
Vascular Dissection 536 658
No Patient Involvement 414 414
Insufficient Information 408 408
Perforation of Vessels 354 476
Perforation 275 275
Vessel Or Plaque, Device Embedded In 245 245
Pericardial Effusion 199 199
Death 198 198
Cardiac Tamponade 191 191
Cardiac Perforation 185 185
Low Blood Pressure/ Hypotension 177 177
No Code Available 156 156
Hemorrhage/Bleeding 121 121
No Information 105 105
Myocardial Infarction 102 102
Intimal Dissection 96 96
Obstruction/Occlusion 70 70
Cardiac Arrest 64 64
Hematoma 63 63
Pain 60 60
Stroke/CVA 58 58
Patient Problem/Medical Problem 53 53
Hemoptysis 49 49
Blood Loss 45 45
Embolism 44 44
Occlusion 42 42
Rupture 37 37
Vasoconstriction 37 37
Embolism/Embolus 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Intracranial Hemorrhage 33 33
Thrombosis/Thrombus 32 32
Thrombosis 31 31
Arrhythmia 25 25
Laceration(s) 25 25
Bradycardia 24 24
Chest Pain 23 23
Headache 23 23
Angina 23 23
Thrombus 22 22
Injury 20 20
Calcium Deposits/Calcification 19 19
Unspecified Infection 18 18
High Blood Pressure/ Hypertension 18 18
Tissue Damage 17 17

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Mar-21-2024
2 Anewmed Corporation II Oct-31-2019
3 Argon Medical Devices, Inc I May-07-2020
4 Arrow International Inc II Jan-23-2020
5 Arrow International Inc II May-30-2018
6 Arrow International Inc II Apr-10-2018
7 Arrow International Inc II Apr-02-2018
8 Arrow International Inc II Jun-12-2017
9 Arrow International Inc II Sep-07-2016
10 Arrow International Inc II Jul-12-2016
11 Bard Peripheral Vascular Inc II Sep-06-2024
12 Boston Scientific Corporation II Feb-20-2019
13 Boston Scientific Corporation II Apr-12-2016
14 Cook Inc. I Nov-03-2020
15 Cook Inc. II Mar-09-2018
16 Cook Inc. I Aug-25-2016
17 Cook Incorporated II Sep-28-2022
18 Cook Incorporated II Sep-09-2022
19 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
20 SentreHeart Inc I Nov-09-2016
21 Stryker Neurovascular II May-31-2024
22 Stryker Neurovascular II May-28-2024
23 Stryker Neurovascular II Oct-29-2019
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