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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
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
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 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1766 2749
Difficult to Remove 1431 1431
Difficult to Advance 1144 1145
Fracture 1120 1121
Break 1054 1057
Detachment of Device or Device Component 1037 1038
Adverse Event Without Identified Device or Use Problem 983 1107
Peeled/Delaminated 839 840
Entrapment of Device 631 1608
Failure to Advance 482 483
Unraveled Material 423 426
Deformation Due to Compressive Stress 411 411
Material Deformation 377 377
Physical Resistance/Sticking 359 359
Material Split, Cut or Torn 341 341
Stretched 340 341
Insufficient Information 332 332
Material Integrity Problem 326 327
Material Twisted/Bent 316 316
Improper or Incorrect Procedure or Method 230 230
Positioning Problem 106 106
Product Quality Problem 100 100
Material Frayed 91 91
Incorrect Measurement 89 89
Material Fragmentation 88 88
Device Contaminated During Manufacture or Shipping 87 87
Patient Device Interaction Problem 79 81
Device Damaged by Another Device 73 73
Material Too Soft/Flexible 67 67
Leak/Splash 66 67
Off-Label Use 66 66
Flaked 63 63
Material Protrusion/Extrusion 63 63
Difficult to Insert 55 55
Use of Device Problem 54 54
Fluid/Blood Leak 53 53
Contamination /Decontamination Problem 48 48
Component Misassembled 47 47
Activation, Positioning or Separation Problem 44 44
Mechanical Jam 41 41
Defective Device 40 40
Device-Device Incompatibility 32 32
Device Contamination with Chemical or Other Material 31 31
Device Dislodged or Dislocated 30 30
Obstruction of Flow 26 26
Malposition of Device 25 25
Material Too Rigid or Stiff 25 25
Difficult or Delayed Positioning 24 25
Communication or Transmission Problem 23 24
Sharp Edges 22 144

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6240 7351
Foreign Body In Patient 1581 1585
No Consequences Or Impact To Patient 662 662
Vascular Dissection 603 727
Insufficient Information 523 529
Device Embedded In Tissue or Plaque 476 478
Perforation of Vessels 401 523
Cardiac Tamponade 218 218
Perforation 200 202
Pericardial Effusion 187 189
Low Blood Pressure/ Hypotension 175 176
Cardiac Perforation 174 174
Myocardial Infarction 146 146
Hemorrhage/Bleeding 144 145
No Known Impact Or Consequence To Patient 142 632
Obstruction/Occlusion 84 84
Hemoptysis 81 81
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 57 57
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
Tachycardia 18 18
Unspecified Infection 18 18
Arrhythmia 16 16
Cardiomyopathy 15 15
Extravasation 15 15
Blood Loss 15 15
High Blood Pressure/ Hypertension 15 15
No Information 14 14
Needle Stick/Puncture 14 14
Ventricular Fibrillation 14 14
Heart Block 14 14
Calcium Deposits/Calcification 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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