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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 12
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 1
FILMECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FMD CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
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 2
PHENOX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA CARDIO ACCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 3
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1337 1337

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1371 2347
Difficult to Remove 1261 1261
Break 1168 1168
Detachment of Device or Device Component 946 946
Fracture 808 808
Peeled/Delaminated 796 796
Adverse Event Without Identified Device or Use Problem 731 853
Entrapment of Device 637 1613
Difficult to Advance 566 566
Detachment Of Device Component 560 560
Failure to Advance 433 433
Material Deformation 386 386
Stretched 365 365
Material Integrity Problem 307 307
Unraveled Material 300 300
Improper or Incorrect Procedure or Method 289 289
Deformation Due to Compressive Stress 228 228
Insufficient Information 181 181
Physical Resistance/Sticking 161 161
Material Split, Cut or Torn 154 154
Device Damaged by Another Device 105 105
Material Twisted/Bent 105 105
Material Fragmentation 102 102
Product Quality Problem 101 101
Difficult To Position 97 97
Material Frayed 97 97
Positioning Problem 93 93
Kinked 82 82
Flaked 77 77
Off-Label Use 75 75
Material Protrusion/Extrusion 72 72
Device Operates Differently Than Expected 63 63
Device Damaged Prior to Use 49 49
Difficult to Insert 48 48
Material Too Soft/Flexible 45 45
Fluid/Blood Leak 44 44
Physical Resistance 44 44
Device Contamination with Chemical or Other Material 42 42
Device Dislodged or Dislocated 41 41
Contamination /Decontamination Problem 40 40
Bent 40 40
Unsealed Device Packaging 39 39
Defective Device 36 36
Use of Device Problem 32 32
Appropriate Term/Code Not Available 27 27
Leak/Splash 26 26
Device Markings/Labelling Problem 25 25
Delamination 22 22
Activation, Positioning or Separation Problem 22 22
Mechanical Problem 20 20
Torn Material 19 19
Patient Device Interaction Problem 18 18
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
Crack 15 15
Physical Property Issue 15 15
Device-Device Incompatibility 14 14
Mechanical Jam 14 14
Retraction Problem 14 14
Obstruction of Flow 12 12
Malposition of Device 12 12
Difficult or Delayed Positioning 12 12
Material Perforation 11 11
Split 10 10
Device Displays Incorrect Message 10 10
Device Contaminated During Manufacture or Shipping 10 10
No Apparent Adverse Event 10 10
Device Handling Problem 9 9
Sharp Edges 9 131
Connection Problem 9 9
Structural Problem 9 9
Material Puncture/Hole 9 9
Occlusion Within Device 8 8
Defective Component 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Packaging Problem 8 8
Scratched Material 8 8
Infusion or Flow Problem 7 7
Output Problem 7 7
Material Distortion 7 7
Component Missing 7 7
Separation Failure 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Collapse 7 7
Migration or Expulsion of Device 6 6
Device Or Device Fragments Location Unknown 6 6
Tear, Rip or Hole in Device Packaging 6 6
Separation Problem 6 6
Component Misassembled 5 5
Human-Device Interface Problem 5 5
Material Rupture 5 5
Degraded 5 5
Contamination 5 5
Accessory Incompatible 5 5
Positioning Failure 4 4
Disconnection 4 4
Device Difficult to Setup or Prepare 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 1932 3030
Device Embedded In Tissue or Plaque 912 912
Foreign Body In Patient 890 890
No Known Impact Or Consequence To Patient 806 1294
No Patient Involvement 347 347
Vascular Dissection 285 407
Insufficient Information 237 237
Perforation of Vessels 210 332
Vessel Or Plaque, Device Embedded In 198 198
Perforation 162 162
Death 153 153
No Code Available 147 147
Cardiac Tamponade 115 115
Pericardial Effusion 112 112
Cardiac Perforation 102 102
Low Blood Pressure/ Hypotension 101 101
Intimal Dissection 86 86
No Information 81 81
Hemorrhage/Bleeding 64 64
Patient Problem/Medical Problem 44 44
Embolism 43 43
Hematoma 42 42
Cardiac Arrest 41 41
Blood Loss 41 41
Pain 40 40
Occlusion 40 40
Myocardial Infarction 40 40
Stroke/CVA 37 37
Thrombosis 27 27
Rupture 26 26
Thrombosis/Thrombus 25 25
Angina 22 22
Arrhythmia 21 21
Headache 21 21
Intracranial Hemorrhage 21 21
Vasoconstriction 20 20
Injury 19 19
Thrombus 18 18
Bradycardia 18 18
Calcium Deposits/Calcification 17 17
Chest Pain 15 15
Unspecified Infection 15 15
Laceration(s) 15 15
Hemoptysis 14 14
Embolus 13 13
Aneurysm 13 13
Tissue Damage 13 13
Stenosis 13 13
Obstruction/Occlusion 12 12
Cardiogenic Shock 12 12
Extravasation 12 12
Ischemia 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Unspecified Tissue Injury 11 11
Foreign Body Embolism 11 11
Inflammation 10 10
High Blood Pressure/ Hypertension 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
Tachycardia 5 5
ST Segment Elevation 5 5
Sepsis 5 5
Pneumothorax 5 5
Hemorrhage, Cerebral 5 5
Air Embolism 5 5
Syncope 5 5
Swelling/ Edema 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Hemorrhagic Stroke 4 4
Dyspnea 4 4
Hypersensitivity/Allergic reaction 4 4
Muscle Weakness 4 4
Paralysis 4 4
Swelling 4 4
Great Vessel Perforation 4 4
Numbness 4 4
Cognitive Changes 4 4
Loss Of Pulse 3 3
Vascular System (Circulation), Impaired 3 3
Thromboembolism 3 3
Coma 3 3
Low Cardiac Output 3 3
Visual Disturbances 3 3
Visual Impairment 3 3
Dysphasia 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 Cook Incorporated II Sep-28-2022
12 Cook Incorporated II Sep-09-2022
13 Stryker Neurovascular II Oct-29-2019
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