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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
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 14
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 3
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
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 2
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 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
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
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 3
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
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 1881 2857
Difficult to Remove 1693 1693
Break 1487 1487
Detachment of Device or Device Component 1258 1258
Fracture 1182 1182
Peeled/Delaminated 1070 1070
Adverse Event Without Identified Device or Use Problem 999 1121
Difficult to Advance 978 978
Entrapment of Device 797 1773
Failure to Advance 585 585
Detachment Of Device Component 560 560
Stretched 497 497
Material Deformation 487 487
Unraveled Material 441 441
Deformation Due to Compressive Stress 408 408
Material Integrity Problem 406 406
Physical Resistance/Sticking 345 345
Improper or Incorrect Procedure or Method 340 340
Material Split, Cut or Torn 298 298
Insufficient Information 277 277
Material Twisted/Bent 250 250
Product Quality Problem 136 136
Device Damaged by Another Device 131 131
Positioning Problem 123 123
Material Frayed 122 122
Material Fragmentation 121 121
Flaked 102 102
Difficult To Position 97 97
Material Protrusion/Extrusion 95 95
Off-Label Use 94 94
Kinked 82 82
Fluid/Blood Leak 63 63
Device Operates Differently Than Expected 63 63
Contamination /Decontamination Problem 63 63
Material Too Soft/Flexible 61 61
Difficult to Insert 59 59
Device Damaged Prior to Use 51 51
Device Contaminated During Manufacture or Shipping 51 51
Use of Device Problem 50 50
Device Contamination with Chemical or Other Material 49 49
Unsealed Device Packaging 48 48
Component Misassembled 47 47
Device Dislodged or Dislocated 46 46
Defective Device 45 45
Physical Resistance 44 44
Activation, Positioning or Separation Problem 43 43
Bent 40 40
Appropriate Term/Code Not Available 37 37
Leak/Splash 36 36
Patient Device Interaction Problem 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4299 5397
No Consequences Or Impact To Patient 3031 3031
Foreign Body In Patient 1485 1485
Device Embedded In Tissue or Plaque 1028 1028
No Known Impact Or Consequence To Patient 806 1294
Vascular Dissection 519 641
Insufficient Information 408 408
No Patient Involvement 347 347
Perforation of Vessels 343 465
Perforation 236 236
Vessel Or Plaque, Device Embedded In 198 198
Pericardial Effusion 180 180
Cardiac Perforation 174 174
Cardiac Tamponade 172 172
Low Blood Pressure/ Hypotension 166 166
Death 153 153
No Code Available 147 147
Hemorrhage/Bleeding 117 117
Myocardial Infarction 102 102
Intimal Dissection 86 86
No Information 81 81
Obstruction/Occlusion 64 64
Cardiac Arrest 58 58
Hematoma 58 58
Pain 57 57
Stroke/CVA 54 54
Hemoptysis 49 49
Patient Problem/Medical Problem 44 44
Embolism 43 43
Blood Loss 41 41
Occlusion 40 40
Rupture 36 36
Embolism/Embolus 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Thrombosis/Thrombus 32 32
Vasoconstriction 32 32
Intracranial Hemorrhage 31 31
Thrombosis 27 27
Laceration(s) 25 25
Headache 23 23
Angina 22 22
Bradycardia 22 22
Arrhythmia 22 22
Chest Pain 20 20
Injury 19 19
Calcium Deposits/Calcification 18 18
Thrombus 18 18
Unspecified Tissue Injury 17 17
High Blood Pressure/ Hypertension 16 16
Unspecified Infection 16 16

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 Bard Peripheral Vascular Inc II Sep-06-2024
10 Boston Scientific Corporation II Feb-20-2019
11 Cook Inc. I Nov-03-2020
12 Cook Inc. II Mar-09-2018
13 Cook Incorporated II Sep-28-2022
14 Cook Incorporated II Sep-09-2022
15 Stryker Neurovascular II May-31-2024
16 Stryker Neurovascular II May-28-2024
17 Stryker Neurovascular II Oct-29-2019
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