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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
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 5
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
OPSENS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SEVEN SONS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLO PACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUREAX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1713 3066
2022 1647 1649
2023 2068 2073
2024 2210 2215
2025 2202 2202
2026 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1448 2186
Difficult to Remove 1232 1232
Difficult to Advance 1037 1038
Fracture 953 954
Break 904 907
Detachment of Device or Device Component 872 873
Adverse Event Without Identified Device or Use Problem 855 857
Peeled/Delaminated 739 740
Entrapment of Device 537 1147
Failure to Advance 412 413
Deformation Due to Compressive Stress 371 371
Unraveled Material 366 368
Physical Resistance/Sticking 327 327
Material Split, Cut or Torn 294 294
Material Twisted/Bent 294 294
Insufficient Information 289 289
Material Deformation 287 287
Stretched 286 287
Material Integrity Problem 262 263
Improper or Incorrect Procedure or Method 190 190
Incorrect Measurement 89 89
Positioning Problem 87 87
Product Quality Problem 85 85
Device Contaminated During Manufacture or Shipping 85 85
Patient Device Interaction Problem 79 81
Material Fragmentation 77 77
Material Frayed 77 77
Leak/Splash 64 65
Device Damaged by Another Device 57 57
Material Too Soft/Flexible 56 56
Material Protrusion/Extrusion 55 55
Flaked 49 49
Fluid/Blood Leak 49 49
Use of Device Problem 47 47
Difficult to Insert 45 45
Off-Label Use 44 44
Component Misassembled 42 42
Activation, Positioning or Separation Problem 41 41
Mechanical Jam 38 38
Contamination /Decontamination Problem 35 35
Defective Device 33 33
Device-Device Incompatibility 30 30
Device Contamination with Chemical or Other Material 28 28
Obstruction of Flow 25 25
Malposition of Device 24 24
Device Dislodged or Dislocated 24 24
Material Too Rigid or Stiff 23 23
Loose or Intermittent Connection 22 22
No Apparent Adverse Event 21 21
Appropriate Term/Code Not Available 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6058 7167
Foreign Body In Patient 1471 1475
Vascular Dissection 566 690
Insufficient Information 506 511
Perforation of Vessels 355 477
Device Embedded In Tissue or Plaque 314 314
Cardiac Tamponade 194 194
Pericardial Effusion 168 170
Perforation 164 166
Low Blood Pressure/ Hypotension 155 156
Cardiac Perforation 152 152
Myocardial Infarction 128 128
Hemorrhage/Bleeding 123 124
Obstruction/Occlusion 84 84
Hemoptysis 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Stroke/CVA 60 60
Hematoma 53 53
Embolism/Embolus 52 53
Pain 50 50
Cardiac Arrest 47 47
Thrombosis/Thrombus 39 39
No Consequences Or Impact To Patient 36 36
Unspecified Tissue Injury 33 33
Intracranial Hemorrhage 29 29
Vasoconstriction 23 23
Bradycardia 22 22
Rupture 19 19
Tachycardia 18 18
Chest Pain 17 17
Laceration(s) 17 17
Cardiomyopathy 15 15
Heart Block 14 14
Needle Stick/Puncture 14 14
Extravasation 13 13
Ventricular Fibrillation 12 12
Thromboembolism 12 12
Failure of Implant 11 11
Ischemia 11 11
Foreign Body Embolism 11 11
Renal Impairment 10 10
Great Vessel Perforation 10 11
Valvular Insufficiency/ Regurgitation 10 10
Discomfort 10 10
Unspecified Infection 9 9
High Blood Pressure/ Hypertension 9 9
Atrial Fibrillation 9 9
Stenosis 8 8
Swelling/ Edema 8 8
Paralysis 8 8

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