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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 1
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 2203 2203

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1425 2163
Difficult to Remove 1205 1205
Difficult to Advance 1013 1014
Fracture 939 940
Break 887 890
Detachment of Device or Device Component 863 864
Adverse Event Without Identified Device or Use Problem 833 835
Peeled/Delaminated 733 734
Entrapment of Device 525 1135
Failure to Advance 410 411
Deformation Due to Compressive Stress 362 362
Unraveled Material 361 363
Physical Resistance/Sticking 321 321
Material Split, Cut or Torn 293 293
Material Twisted/Bent 288 288
Material Deformation 285 285
Stretched 283 284
Insufficient Information 280 280
Material Integrity Problem 262 263
Improper or Incorrect Procedure or Method 188 188
Incorrect Measurement 89 89
Positioning Problem 86 86
Device Contaminated During Manufacture or Shipping 85 85
Product Quality Problem 85 85
Patient Device Interaction Problem 76 78
Material Fragmentation 75 75
Material Frayed 75 75
Leak/Splash 62 63
Device Damaged by Another Device 57 57
Material Too Soft/Flexible 56 56
Material Protrusion/Extrusion 52 52
Fluid/Blood Leak 49 49
Use of Device Problem 47 47
Flaked 46 46
Difficult to Insert 45 45
Off-Label Use 44 44
Component Misassembled 42 42
Activation, Positioning or Separation Problem 40 40
Mechanical Jam 36 36
Contamination /Decontamination Problem 35 35
Defective Device 32 32
Device-Device Incompatibility 29 29
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
No Apparent Adverse Event 21 21
Sharp Edges 21 143
Appropriate Term/Code Not Available 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 5961 7070
Foreign Body In Patient 1450 1454
Vascular Dissection 551 675
Insufficient Information 499 504
Perforation of Vessels 344 466
Device Embedded In Tissue or Plaque 314 314
Cardiac Tamponade 183 183
Pericardial Effusion 164 166
Perforation 164 166
Low Blood Pressure/ Hypotension 151 152
Cardiac Perforation 146 146
Hemorrhage/Bleeding 123 124
Myocardial Infarction 120 120
Obstruction/Occlusion 84 84
Hemoptysis 78 78
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Stroke/CVA 59 59
Embolism/Embolus 52 53
Hematoma 51 51
Pain 48 48
Cardiac Arrest 45 45
Thrombosis/Thrombus 38 38
No Consequences Or Impact To Patient 36 36
Unspecified Tissue Injury 33 33
Intracranial Hemorrhage 29 29
Vasoconstriction 23 23
Bradycardia 21 21
Rupture 19 19
Chest Pain 17 17
Laceration(s) 17 17
Tachycardia 17 17
Cardiomyopathy 15 15
Needle Stick/Puncture 14 14
Heart Block 14 14
Extravasation 13 13
Ventricular Fibrillation 12 12
Thromboembolism 12 12
Foreign Body Embolism 11 11
Failure of Implant 11 11
Ischemia 11 11
Discomfort 10 10
Renal Impairment 10 10
Valvular Insufficiency/ Regurgitation 10 10
Great Vessel Perforation 10 11
Atrial Fibrillation 9 9
High Blood Pressure/ Hypertension 9 9
Stenosis 8 8
Aortic Valve Insufficiency/ Regurgitation 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Swelling/ Edema 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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