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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 3
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
  1.  K200144  HI-TORQUE Steelcore Bare Guide Wire
  2.  K201834  HI-TORQUE PROCEED Guide Wire Family
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 IRELAND LTD.,
  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
SUREAX MEDICAL, LLC
  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 2

MDR Year MDR Reports MDR Events
2020 1536 2026
2021 1713 3058
2022 1647 1648
2023 2068 2069
2024 2210 2210
2025 1804 1804

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1691 2669
Difficult to Remove 1344 1344
Difficult to Advance 1087 1087
Fracture 1075 1075
Detachment of Device or Device Component 995 996
Break 991 991
Adverse Event Without Identified Device or Use Problem 911 1033
Peeled/Delaminated 809 809
Entrapment of Device 587 1564
Failure to Advance 464 464
Unraveled Material 411 411
Deformation Due to Compressive Stress 387 387
Material Deformation 367 367
Physical Resistance/Sticking 346 346
Material Split, Cut or Torn 335 335
Stretched 328 328
Material Integrity Problem 320 320
Insufficient Information 312 312
Material Twisted/Bent 300 300
Improper or Incorrect Procedure or Method 225 225
Positioning Problem 104 104
Product Quality Problem 99 99
Incorrect Measurement 88 88
Material Fragmentation 85 85
Material Frayed 85 85
Device Damaged by Another Device 73 73
Device Contaminated During Manufacture or Shipping 68 68
Material Too Soft/Flexible 67 67
Off-Label Use 66 66
Patient Device Interaction Problem 66 66
Material Protrusion/Extrusion 60 60
Flaked 57 57
Use of Device Problem 54 54
Difficult to Insert 52 52
Fluid/Blood Leak 52 52
Contamination /Decontamination Problem 48 48
Component Misassembled 47 47
Leak/Splash 47 47
Activation, Positioning or Separation Problem 43 43
Defective Device 39 39
Mechanical Jam 36 36
Device Dislodged or Dislocated 29 29
Device-Device Incompatibility 29 29
Device Contamination with Chemical or Other Material 28 28
Obstruction of Flow 26 26
Difficult or Delayed Positioning 24 24
Communication or Transmission Problem 23 23
Malposition of Device 22 22
Sharp Edges 22 144
Material Too Rigid or Stiff 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5869 6968
Foreign Body In Patient 1521 1521
No Consequences Or Impact To Patient 662 662
Vascular Dissection 582 704
Insufficient Information 502 507
Device Embedded In Tissue or Plaque 469 470
Perforation of Vessels 374 496
Cardiac Tamponade 196 196
Perforation 191 191
Pericardial Effusion 168 168
Low Blood Pressure/ Hypotension 164 164
Cardiac Perforation 158 158
No Known Impact Or Consequence To Patient 142 630
Hemorrhage/Bleeding 140 140
Myocardial Infarction 138 138
Obstruction/Occlusion 82 82
Hemoptysis 78 78
Stroke/CVA 74 74
No Patient Involvement 61 61
Vessel Or Plaque, Device Embedded In 59 59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Hematoma 58 58
Cardiac Arrest 54 54
Embolism/Embolus 52 52
Pain 50 50
Death 45 45
No Code Available 44 44
Thrombosis/Thrombus 40 40
Unspecified Tissue Injury 33 33
Intimal Dissection 32 32
Intracranial Hemorrhage 31 31
Vasoconstriction 29 29
Embolism 26 26
Bradycardia 23 23
Laceration(s) 22 22
Chest Pain 21 21
Rupture 21 21
Occlusion 19 19
Tachycardia 17 17
Blood Loss 15 15
Arrhythmia 15 15
Extravasation 15 15
Cardiomyopathy 15 15
Unspecified Infection 15 15
High Blood Pressure/ Hypertension 15 15
Heart Block 14 14
No Information 14 14
Failure of Implant 13 13
Calcium Deposits/Calcification 13 13
Ischemia 13 13

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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