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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
Regulation Description Catheter guide wire.
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 2
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
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
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 2068 2068
2024 2219 2219
2025 883 883

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1547 2523
Difficult to Remove 1230 1230
Difficult to Advance 997 997
Fracture 995 995
Detachment of Device or Device Component 934 934
Break 877 877
Adverse Event Without Identified Device or Use Problem 806 928
Peeled/Delaminated 764 764
Entrapment of Device 512 1488
Failure to Advance 435 435
Unraveled Material 371 371
Deformation Due to Compressive Stress 368 368
Material Deformation 342 342
Physical Resistance/Sticking 317 317
Stretched 308 308
Material Split, Cut or Torn 301 301
Insufficient Information 301 301
Material Integrity Problem 291 291
Material Twisted/Bent 266 266
Improper or Incorrect Procedure or Method 213 213
Product Quality Problem 97 97
Positioning Problem 96 96
Incorrect Measurement 87 87
Material Frayed 79 79
Device Damaged by Another Device 68 68
Off-Label Use 63 63
Material Fragmentation 63 63
Device Contaminated During Manufacture or Shipping 62 62
Material Too Soft/Flexible 59 59
Material Protrusion/Extrusion 57 57
Flaked 54 54
Patient Device Interaction Problem 51 51
Use of Device Problem 51 51
Fluid/Blood Leak 49 49
Contamination /Decontamination Problem 48 48
Component Misassembled 47 47
Difficult to Insert 45 45
Activation, Positioning or Separation Problem 37 37
Defective Device 37 37
Leak/Splash 37 37
Mechanical Jam 29 29
Device Dislodged or Dislocated 26 26
Communication or Transmission Problem 24 24
Obstruction of Flow 24 24
Device-Device Incompatibility 24 24
Difficult or Delayed Positioning 22 22
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Device Contamination with Chemical or Other Material 21 21
Unsealed Device Packaging 21 21
Material Too Rigid or Stiff 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5312 6410
Foreign Body In Patient 1347 1347
No Consequences Or Impact To Patient 662 662
Vascular Dissection 558 680
Insufficient Information 459 459
Device Embedded In Tissue or Plaque 450 450
Perforation of Vessels 364 486
Cardiac Tamponade 181 181
Perforation 176 176
Low Blood Pressure/ Hypotension 148 148
Cardiac Perforation 147 147
Pericardial Effusion 143 143
No Known Impact Or Consequence To Patient 142 630
Myocardial Infarction 135 135
Hemorrhage/Bleeding 128 128
Obstruction/Occlusion 78 78
Stroke/CVA 70 70
Hemoptysis 67 67
No Patient Involvement 61 61
Vessel Or Plaque, Device Embedded In 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 55
Hematoma 54 54
Embolism/Embolus 48 48
Pain 47 47
Death 45 45
No Code Available 44 44
Cardiac Arrest 43 43
Thrombosis/Thrombus 37 37
Intimal Dissection 32 32
Vasoconstriction 28 28
Intracranial Hemorrhage 27 27
Embolism 26 26
Unspecified Tissue Injury 24 24
Laceration(s) 22 22
Chest Pain 20 20
Rupture 19 19
Occlusion 19 19
Bradycardia 18 18
Tachycardia 17 17
Extravasation 15 15
High Blood Pressure/ Hypertension 15 15
Blood Loss 15 15
Cardiomyopathy 15 15
No Information 14 14
Arrhythmia 14 14
Failure of Implant 13 13
Thromboembolism 12 12
Needle Stick/Puncture 12 12
Foreign Body Embolism 12 12
Unspecified Infection 12 12

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Sep-26-2024
2 ARROW INTERNATIONAL Inc. I Mar-21-2024
3 Argon Medical Devices, Inc I May-07-2020
4 Arrow International Inc II Jan-23-2020
5 Bard Peripheral Vascular Inc II Sep-06-2024
6 Cook Inc. I Nov-03-2020
7 Cook Incorporated II Nov-21-2024
8 Cook Incorporated II Nov-08-2024
9 Cook Incorporated II Sep-28-2022
10 Cook Incorporated II Sep-09-2022
11 Galt Medical Corporation II May-07-2025
12 Stryker Neurovascular II May-31-2024
13 Stryker Neurovascular II May-28-2024
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