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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
  1.  K192599  ASAHI PTCA Guide Wire ASAHI Gaia Next
  2.  K211898  ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
  3.  K213315  CROSSLEAD Peripheral Guide Wire
  4.  K213868  ASAHI Gladius Mongo18 PV ES
  5.  K230377  CROSSLEAD Penetration Peripheral Guide Wire
  6.  K240387  MINAMO blue; MINAMO viola
  7.  K241510  CROSSLEAD Tracker
  8.  K241702  CROSSLEAD 0.014inch
  9.  K241962  Crossloop
  10.  K242597  CROSSLEAD 0.018inch
  11.  K243733  SION blue PLUS
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 3
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
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 2201 2201
2026 688 688

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1836 2819
Difficult to Remove 1506 1506
Difficult to Advance 1194 1195
Fracture 1173 1174
Break 1118 1121
Detachment of Device or Device Component 1071 1072
Adverse Event Without Identified Device or Use Problem 1055 1179
Peeled/Delaminated 876 877
Entrapment of Device 669 1646
Failure to Advance 498 499
Unraveled Material 436 439
Deformation Due to Compressive Stress 423 423
Material Deformation 392 392
Physical Resistance/Sticking 373 373
Material Split, Cut or Torn 362 362
Stretched 355 356
Insufficient Information 348 348
Material Integrity Problem 334 335
Material Twisted/Bent 330 330
Improper or Incorrect Procedure or Method 242 242
Positioning Problem 109 109
Product Quality Problem 108 108
Patient Device Interaction Problem 100 102
Material Fragmentation 94 94
Material Frayed 92 92
Device Contaminated During Manufacture or Shipping 89 89
Incorrect Measurement 89 89
Device Damaged by Another Device 78 78
Material Too Soft/Flexible 72 72
Leak/Splash 71 72
Flaked 67 67
Off-Label Use 66 66
Material Protrusion/Extrusion 65 65
Difficult to Insert 59 59
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 44 44
Defective Device 41 41
Device-Device Incompatibility 34 34
Loose or Intermittent Connection 32 32
Device Contamination with Chemical or Other Material 32 32
Device Dislodged or Dislocated 31 31
Malposition of Device 27 27
Material Too Rigid or Stiff 27 27
Obstruction of Flow 26 26
Appropriate Term/Code Not Available 25 25
Difficult or Delayed Positioning 24 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6555 7666
Foreign Body In Patient 1659 1663
No Consequences Or Impact To Patient 662 662
Vascular Dissection 621 745
Insufficient Information 535 541
Device Embedded In Tissue or Plaque 484 486
Perforation of Vessels 417 539
Cardiac Tamponade 236 236
Pericardial Effusion 225 227
Perforation 215 217
Low Blood Pressure/ Hypotension 196 197
Cardiac Perforation 185 185
Hemorrhage/Bleeding 154 155
Myocardial Infarction 146 146
No Known Impact Or Consequence To Patient 142 632
Hemoptysis 94 94
Obstruction/Occlusion 87 87
Stroke/CVA 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 63 63
Cardiac Arrest 62 62
Hematoma 61 61
No Patient Involvement 61 61
Vessel Or Plaque, Device Embedded In 59 59
Embolism/Embolus 54 55
Pain 52 52
Death 45 45
No Code Available 44 44
Thrombosis/Thrombus 43 43
Unspecified Tissue Injury 35 35
Intimal Dissection 32 32
Intracranial Hemorrhage 31 31
Vasoconstriction 30 30
Embolism 26 26
Bradycardia 24 24
Laceration(s) 23 23
Rupture 23 23
Chest Pain 23 23
Tachycardia 19 19
Occlusion 19 19
Heart Block 18 18
Unspecified Infection 18 18
Arrhythmia 16 16
Blood Loss 15 15
Extravasation 15 15
Cardiomyopathy 15 15
Needle Stick/Puncture 15 15
High Blood Pressure/ Hypertension 15 15
No Information 14 14
Ischemia 14 14
Ventricular Fibrillation 14 14

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 Apr-06-2026
8 Cook Incorporated II Nov-21-2024
9 Cook Incorporated II Nov-08-2024
10 Cook Incorporated II Sep-28-2022
11 Cook Incorporated II Sep-09-2022
12 Galt Medical Corporation II May-07-2025
13 Medline Industries, LP II Apr-17-2026
14 Stryker Neurovascular II May-31-2024
15 Stryker Neurovascular II May-28-2024
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