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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
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 2
BRIVANT LIMITED (LAKE REGION MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
EMBRACE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMEC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FILMECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 3
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA CARDIO ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1677 1677
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 2069 2069
2024 1621 1621

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1649 2625
Difficult to Remove 1265 1265
Detachment of Device or Device Component 1102 1102
Break 1019 1019
Fracture 1010 1010
Difficult to Advance 924 924
Adverse Event Without Identified Device or Use Problem 787 909
Peeled/Delaminated 780 780
Entrapment of Device 547 1523
Failure to Advance 452 452
Material Deformation 389 389
Deformation Due to Compressive Stress 376 376
Unraveled Material 365 365
Stretched 356 356
Physical Resistance/Sticking 326 326
Material Integrity Problem 319 319
Material Split, Cut or Torn 278 278
Insufficient Information 237 237
Improper or Incorrect Procedure or Method 237 237
Material Twisted/Bent 222 222
Product Quality Problem 123 123
Positioning Problem 99 99
Material Frayed 91 91
Device Damaged by Another Device 87 87
Off-Label Use 84 84
Material Fragmentation 68 68
Flaked 68 68
Contamination /Decontamination Problem 62 62
Material Protrusion/Extrusion 58 58
Material Too Soft/Flexible 54 54
Device Contaminated During Manufacture or Shipping 51 51
Difficult to Insert 50 50
Fluid/Blood Leak 48 48
Use of Device Problem 47 47
Component Misassembled 47 47
Unsealed Device Packaging 41 41
Activation, Positioning or Separation Problem 40 40
Defective Device 37 37
Patient Device Interaction Problem 32 32
Device Dislodged or Dislocated 28 28
Mechanical Jam 26 26
Leak/Splash 25 25
Device-Device Incompatibility 24 24
Device Contamination with Chemical or Other Material 24 24
Material Too Rigid or Stiff 23 23
Delivered as Unsterile Product 22 22
Device Damaged Prior to Use 20 20
Appropriate Term/Code Not Available 20 20
Sharp Edges 20 142
Device Markings/Labelling Problem 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4390 5488
No Consequences Or Impact To Patient 1459 1459
Foreign Body In Patient 1304 1304
Device Embedded In Tissue or Plaque 620 620
Vascular Dissection 489 611
Insufficient Information 410 410
No Known Impact Or Consequence To Patient 354 842
Perforation of Vessels 297 419
Perforation 187 187
No Patient Involvement 169 169
Cardiac Perforation 144 144
Pericardial Effusion 144 144
Cardiac Tamponade 142 142
Low Blood Pressure/ Hypotension 136 136
Hemorrhage/Bleeding 108 108
Vessel Or Plaque, Device Embedded In 105 105
Myocardial Infarction 99 99
No Code Available 97 97
Death 81 81
Obstruction/Occlusion 63 63
Hemoptysis 55 55
Cardiac Arrest 51 51
Stroke/CVA 50 50
Pain 48 48
Hematoma 48 48
Intimal Dissection 47 47
Embolism 38 38
No Information 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Embolism/Embolus 34 34
Thrombosis/Thrombus 33 33
Intracranial Hemorrhage 29 29
Blood Loss 29 29
Vasoconstriction 29 29
Rupture 26 26
Occlusion 26 26
Laceration(s) 23 23
Patient Problem/Medical Problem 22 22
Arrhythmia 19 19
Bradycardia 18 18
Unspecified Tissue Injury 17 17
High Blood Pressure/ Hypertension 17 17
Unspecified Infection 16 16
Injury 15 15
Tachycardia 15 15
Calcium Deposits/Calcification 14 14
Extravasation 14 14
Chest Pain 14 14
Thrombosis 13 13
Thrombus 12 12

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Sep-26-2024
2 ARROW INTERNATIONAL Inc. I Mar-21-2024
3 Anewmed Corporation II Oct-31-2019
4 Argon Medical Devices, Inc I May-07-2020
5 Arrow International Inc II Jan-23-2020
6 Bard Peripheral Vascular Inc II Sep-06-2024
7 Boston Scientific Corporation II Feb-20-2019
8 Cook Inc. I Nov-03-2020
9 Cook Incorporated II Sep-28-2022
10 Cook Incorporated II Sep-09-2022
11 Stryker Neurovascular II May-31-2024
12 Stryker Neurovascular II May-28-2024
13 Stryker Neurovascular II Oct-29-2019
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