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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
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
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 5
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K212615  EpiFaith CV
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1
OPSENS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIENTIA VASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEVEN SONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLO PACE, INC.
  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 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1536 2028
2021 1713 3066
2022 1647 1649
2023 2068 2073
2024 2210 2215
2025 2202 2202
2026 328 328

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1783 2766
Difficult to Remove 1448 1448
Difficult to Advance 1160 1161
Fracture 1136 1137
Break 1073 1076
Detachment of Device or Device Component 1048 1049
Adverse Event Without Identified Device or Use Problem 1005 1129
Peeled/Delaminated 844 845
Entrapment of Device 643 1620
Failure to Advance 489 490
Unraveled Material 429 432
Deformation Due to Compressive Stress 416 416
Material Deformation 383 383
Physical Resistance/Sticking 363 363
Material Split, Cut or Torn 347 347
Stretched 344 345
Insufficient Information 333 333
Material Integrity Problem 330 331
Material Twisted/Bent 319 319
Improper or Incorrect Procedure or Method 233 233
Positioning Problem 106 106
Product Quality Problem 103 103
Material Frayed 91 91
Material Fragmentation 91 91
Incorrect Measurement 89 89
Device Contaminated During Manufacture or Shipping 88 88
Patient Device Interaction Problem 85 87
Device Damaged by Another Device 73 73
Leak/Splash 71 72
Material Too Soft/Flexible 69 69
Off-Label Use 66 66
Flaked 64 64
Material Protrusion/Extrusion 63 63
Difficult to Insert 56 56
Use of Device Problem 55 55
Fluid/Blood Leak 53 53
Contamination /Decontamination Problem 48 48
Component Misassembled 47 47
Activation, Positioning or Separation Problem 46 46
Mechanical Jam 43 43
Defective Device 41 41
Device-Device Incompatibility 33 33
Device Contamination with Chemical or Other Material 32 32
Device Dislodged or Dislocated 30 30
Loose or Intermittent Connection 30 30
Malposition of Device 26 26
Obstruction of Flow 26 26
Material Too Rigid or Stiff 26 26
Difficult or Delayed Positioning 24 25
Communication or Transmission Problem 24 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6346 7457
Foreign Body In Patient 1603 1607
No Consequences Or Impact To Patient 662 662
Vascular Dissection 609 733
Insufficient Information 527 533
Device Embedded In Tissue or Plaque 479 481
Perforation of Vessels 410 532
Cardiac Tamponade 224 224
Perforation 204 206
Pericardial Effusion 194 196
Low Blood Pressure/ Hypotension 182 183
Cardiac Perforation 178 178
Hemorrhage/Bleeding 146 147
Myocardial Infarction 146 146
No Known Impact Or Consequence To Patient 142 632
Obstruction/Occlusion 84 84
Hemoptysis 82 82
Stroke/CVA 76 76
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
No Patient Involvement 61 61
Hematoma 60 60
Vessel Or Plaque, Device Embedded In 59 59
Cardiac Arrest 59 59
Embolism/Embolus 53 54
Pain 52 52
Death 45 45
No Code Available 44 44
Thrombosis/Thrombus 43 43
Unspecified Tissue Injury 33 33
Intimal Dissection 32 32
Intracranial Hemorrhage 31 31
Vasoconstriction 30 30
Embolism 26 26
Bradycardia 24 24
Laceration(s) 23 23
Chest Pain 21 21
Rupture 21 21
Occlusion 19 19
Unspecified Infection 18 18
Tachycardia 18 18
Arrhythmia 16 16
Cardiomyopathy 15 15
Extravasation 15 15
High Blood Pressure/ Hypertension 15 15
Blood Loss 15 15
Needle Stick/Puncture 15 15
Ventricular Fibrillation 14 14
Heart Block 14 14
No Information 14 14
Failure of Implant 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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