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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 5
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
ASHITAKA FACTORY OF TERUMO COPORATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
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 10
FILMECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CORE VALVE, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA CARDIO ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., 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 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1523 1523
2018 1734 1734
2019 1677 1677
2020 1536 2024
2021 1714 3056
2022 892 892

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1317 2293
Difficult to Remove 1205 1205
Break 1116 1116
Detachment of Device or Device Component 874 874
Fracture 771 771
Peeled/Delaminated 766 766
Adverse Event Without Identified Device or Use Problem 693 815
Entrapment of Device 615 1591
Detachment Of Device Component 560 560
Difficult to Advance 522 522
Failure to Advance 419 419
Material Deformation 373 373
Stretched 351 351
Material Integrity Problem 294 294
Improper or Incorrect Procedure or Method 284 284
Unraveled Material 282 282
Deformation Due to Compressive Stress 198 198
Insufficient Information 169 169
Material Split, Cut or Torn 147 147
Physical Resistance/Sticking 147 147
Material Twisted/Bent 103 103
Device Damaged by Another Device 101 101
Material Fragmentation 100 100
Difficult To Position 97 97
Material Frayed 93 93
Product Quality Problem 91 91
Positioning Problem 88 88
Kinked 82 82
Flaked 74 74
Off-Label Use 71 71
Material Protrusion/Extrusion 69 69
Device Operates Differently Than Expected 63 63
Device Damaged Prior to Use 48 48
Physical Resistance 44 44
Material Too Soft/Flexible 44 44
Device Contamination with Chemical or Other Material 42 42
Device Dislodged or Dislocated 41 41
Difficult to Insert 41 41
Bent 40 40
Fluid Leak 39 39
Contamination /Decontamination Problem 38 38
Unsealed Device Packaging 36 36
Defective Device 35 35
Use of Device Problem 30 30
Leak/Splash 26 26
Device Markings/Labelling Problem 25 25
Appropriate Term/Code Not Available 24 24
Delamination 22 22
Activation, Positioning or SeparationProblem 21 21
Mechanical Problem 20 20
Torn Material 19 19
Delivered as Unsterile Product 18 18
Uncoiled 17 17
Sticking 16 16
Communication or Transmission Problem 16 16
Material Too Rigid or Stiff 16 16
Patient Device Interaction Problem 16 16
Physical Property Issue 15 15
Retraction Problem 14 14
Device-Device Incompatibility 13 13
Crack 13 13
Obstruction of Flow 12 12
Material Perforation 11 11
Difficult or Delayed Positioning 11 11
Split 10 10
Device Displays Incorrect Message 10 10
Malposition of Device 10 10
Structural Problem 9 9
Device Contaminated During Manufacture or Shipping 9 9
No Apparent Adverse Event 9 9
Device Handling Problem 9 9
Scratched Material 8 8
Sharp Edges 8 130
Device Misassembled During Manufacturing /Shipping 8 8
Connection Problem 8 8
Defective Component 8 8
Material Puncture/Hole 8 8
Occlusion Within Device 8 8
Incorrect, Inadequate or Imprecise Resultor Readings 7 7
Collapse 7 7
Separation Failure 7 7
Material Distortion 7 7
Mechanical Jam 7 7
Output Problem 7 7
Packaging Problem 7 7
Infusion or Flow Problem 7 7
Separation Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Or Device Fragments Location Unknown 6 6
Component Missing 6 6
Migration or Expulsion of Device 6 6
Accessory Incompatible 5 5
Human-Device Interface Problem 5 5
Component Misassembled 5 5
Compatibility Problem 4 4
Material Torqued 4 4
Solder Joint Fracture 4 4
Failure to Zero 4 4
Patient-Device Incompatibility 4 4
Failure to Align 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3030 3030
No Clinical Signs, Symptoms or Conditions 1652 2750
Device Embedded In Tissue or Plaque 886 886
Foreign Body In Patient 844 844
No Known Impact Or Consequence To Patient 806 1294
No Patient Involvement 347 347
Vascular Dissection 261 383
Insufficient Information 219 219
Vessel Or Plaque, Device Embedded In 198 198
Perforation of Vessels 188 310
Perforation 157 157
Death 153 153
No Code Available 147 147
Cardiac Tamponade 109 109
Pericardial Effusion 108 108
Cardiac Perforation 97 97
Low Blood Pressure/ Hypotension 94 94
Intimal Dissection 86 86
No Information 81 81
Hemorrhage/Bleeding 59 59
Patient Problem/Medical Problem 44 44
Embolism 43 43
Hematoma 41 41
Blood Loss 41 41
Occlusion 40 40
Myocardial Infarction 40 40
Cardiac Arrest 39 39
Pain 36 36
Stroke/CVA 35 35
Thrombosis 27 27
Rupture 26 26
Headache 21 21
Arrhythmia 21 21
Angina 21 21
Thrombosis/Thrombus 21 21
Intracranial Hemorrhage 20 20
Injury 19 19
Thrombus 18 18
Vasoconstriction 18 18
Calcium Deposits/Calcification 17 17
Bradycardia 16 16
Chest Pain 15 15
Unspecified Infection 14 14
Laceration(s) 14 14
Embolus 13 13
Aneurysm 13 13
Tissue Damage 13 13
Stenosis 12 12
Extravasation 12 12
Ischemia 12 12
Hemoptysis 11 11
Cardiogenic Shock 11 11
Obstruction/Occlusion 11 11
Foreign Body Embolism 11 11
Unspecified Tissue Injury 11 11
High Blood Pressure/ Hypertension 10 10
Inflammation 10 10
Hemorrhage, Subarachnoid 9 9
Complete Heart Block 9 9
Embolism/Embolus 9 9
Transient Ischemic Attack 8 8
Ventricular Fibrillation 7 7
Bone Fracture(s) 7 7
Non specific EKG/ECG Changes 7 7
Cardiopulmonary Arrest 7 7
Atrial Fibrillation 7 7
Mitral Regurgitation 6 6
Pleural Effusion 6 6
Pseudoaneurysm 6 6
Aortic Dissection 6 6
Respiratory Failure 5 5
Discomfort 5 5
ST Segment Elevation 5 5
Sepsis 5 5
Pneumothorax 5 5
Hemorrhage, Cerebral 5 5
Syncope 5 5
Dyspnea 4 4
Hypersensitivity/Allergic reaction 4 4
Muscle Weakness 4 4
Swelling 4 4
Tachycardia 4 4
Great Vessel Perforation 4 4
Numbness 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Hemorrhagic Stroke 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Swelling/ Edema 3 3
Not Applicable 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Coma 3 3
Low Cardiac Output 3 3
Thromboembolism 3 3
Loss Of Pulse 3 3
Vascular System (Circulation), Impaired 3 3
Cognitive Changes 3 3
Neurological Deficit/Dysfunction 3 3
Visual Impairment 3 3
Visual Disturbances 3 3
Brain Injury 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Anewmed Corporation II Oct-31-2019
2 Argon Medical Devices, Inc I May-07-2020
3 Arrow International Inc II Jan-23-2020
4 Arrow International Inc II May-30-2018
5 Arrow International Inc II Apr-10-2018
6 Arrow International Inc II Apr-02-2018
7 Arrow International Inc II Jun-12-2017
8 Boston Scientific Corporation II Feb-20-2019
9 Cook Inc. I Nov-03-2020
10 Cook Inc. II Mar-09-2018
11 Stryker Neurovascular II Oct-29-2019
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