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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 VASCULAR
  SUBSTANTIALLY EQUIVALENT 5
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
ASAHI INTECC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 4
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
BRIVANT LIMITED (LAKE REGION MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL, LLC
  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
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 2
OPSENS
  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
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
TATARA VASCULAR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1463 1463
2017 1523 1523
2018 1734 1734
2019 1677 1677
2020 1534 2022
2021 1158 2500

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 1254 1254
Break 1144 1144
Material Separation 1127 2103
Detachment Of Device Component 893 893
Peeled/Delaminated 784 784
Detachment of Device or Device Component 740 740
Fracture 725 725
Adverse Event Without Identified Device or Use Problem 690 812
Entrapment of Device 640 1616
Failure to Advance 402 402
Difficult to Advance 396 396
Stretched 372 372
Material Deformation 371 371
Material Integrity Problem 283 283
Improper or Incorrect Procedure or Method 279 279
Unraveled Material 237 237
Difficult To Position 162 162
Insufficient Information 146 146
Kinked 135 135
Deformation Due to Compressive Stress 131 131
Material Fragmentation 129 129
Flaked 125 125
Material Split, Cut or Torn 116 116
Device Damaged by Another Device 111 111
Physical Resistance/Sticking 110 110
Physical Resistance 101 101
Positioning Problem 97 97
Material Twisted/Bent 94 94
Material Frayed 92 92
Device Operates Differently Than Expected 80 80
Product Quality Problem 70 70
Material Protrusion/Extrusion 66 66
Off-Label Use 62 62
Device Damaged Prior to Use 59 59
Device Contamination with Chemical or Other Material 45 45
Bent 44 44
Difficult to Insert 42 42
Device Dislodged or Dislocated 40 40
Material Too Soft/Flexible 39 39
Occlusion Within Device 35 35
Delamination 33 33
Contamination /Decontamination Problem 33 33
Unsealed Device Packaging 32 32
Physical Property Issue 31 31
Torn Material 30 30
Defective Device 30 30
Fluid Leak 29 29
Leak/Splash 26 26
Use of Device Problem 24 24
Uncoiled 24 24
Device Markings/Labelling Problem 23 23
Appropriate Term/Code Not Available 23 23
Sticking 22 22
Mechanical Problem 19 19
Retraction Problem 18 18
Activation, Positioning or SeparationProblem 18 18
Material Too Rigid or Stiff 15 15
Device Misassembled During Manufacturing /Shipping 14 14
Device Displays Incorrect Message 12 12
Difficult or Delayed Positioning 12 12
Crack 11 11
Split 11 11
Material Perforation 11 11
Device Or Device Fragments Location Unknown 10 10
Communication or Transmission Problem 10 10
Material Distortion 10 10
Device-Device Incompatibility 9 9
Connection Problem 9 9
Malposition of Device 9 9
Structural Problem 9 9
Collapse 9 9
Migration or Expulsion of Device 9 9
Separation Failure 8 8
Scratched Material 8 8
Packaging Problem 7 7
Device Handling Problem 7 7
Defective Component 7 7
Component Missing 7 7
Infusion or Flow Problem 7 7
Device Contaminated During Manufacture or Shipping 7 7
Mechanical Jam 7 7
Delivered as Unsterile Product 7 7
Partial Blockage 7 7
Disconnection 6 6
Unable to Obtain Readings 6 6
Device Difficult to Setup or Prepare 6 6
Human-Device Interface Problem 6 6
Cut In Material 6 6
Patient-Device Incompatibility 6 6
No Apparent Adverse Event 6 6
Separation Problem 5 5
Sharp Edges 5 127
Patient Device Interaction Problem 5 5
Component Misassembled 5 5
Compatibility Problem 5 5
Material Torqued 5 5
Device Issue 5 5
Tear, Rip or Hole in Device Packaging 5 5
Obstruction of Flow 5 5
Material Puncture/Hole 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3704 3704
Device Embedded In Tissue or Plaque 1041 1041
No Known Impact Or Consequence To Patient 1017 1505
No Clinical Signs, Symptoms or Conditions 775 1873
Foreign Body In Patient 709 709
No Patient Involvement 414 414
Vessel Or Plaque, Device Embedded In 245 245
Death 198 198
Perforation 185 185
Vascular Dissection 183 305
Perforation of Vessels 168 290
No Code Available 156 156
Insufficient Information 128 128
Pericardial Effusion 111 111
Cardiac Tamponade 105 105
No Information 105 105
Intimal Dissection 96 96
Low Blood Pressure/ Hypotension 94 94
Cardiac Perforation 90 90
Hemorrhage/Bleeding 53 53
Patient Problem/Medical Problem 53 53
Blood Loss 45 45
Embolism 44 44
Occlusion 42 42
Cardiac Arrest 39 39
Hematoma 37 37
Myocardial Infarction 35 35
Stroke/CVA 34 34
Thrombosis 31 31
Pain 30 30
Rupture 24 24
Thrombus 22 22
Arrhythmia 22 22
Headache 21 21
Injury 20 20
Angina 19 19
Vasoconstriction 19 19
Chest Pain 18 18
Tissue Damage 17 17
Calcium Deposits/Calcification 17 17
Unspecified Infection 16 16
Aneurysm 15 15
Stenosis 14 14
Bradycardia 13 13
Embolus 13 13
Intracranial Hemorrhage 13 13
Thrombosis/Thrombus 12 12
Obstruction/Occlusion 12 12
Hemorrhage, Subarachnoid 11 11
Laceration(s) 11 11
Ischemia 11 11
High Blood Pressure/ Hypertension 10 10
Extravasation 10 10
Non specific EKG/ECG Changes 9 9
Inflammation 9 9
Foreign Body Embolism 9 9
Complete Heart Block 9 9
Aortic Dissection 9 9
Hemoptysis 9 9
Cardiogenic Shock 9 9
Unspecified Tissue Injury 8 8
Transient Ischemic Attack 8 8
Respiratory Failure 7 7
Mitral Regurgitation 7 7
Cardiopulmonary Arrest 7 7
Ventricular Fibrillation 7 7
Pseudoaneurysm 7 7
Bone Fracture(s) 7 7
Atrial Fibrillation 7 7
Discomfort 6 6
Pleural Effusion 6 6
Internal Organ Perforation 6 6
Not Applicable 6 6
Hemorrhage, Cerebral 6 6
ST Segment Elevation 6 6
Sepsis 6 6
Swelling 6 6
Dyspnea 5 5
Neurological Deficit/Dysfunction 5 5
Pneumothorax 5 5
Syncope 5 5
Infarction, Cerebral 4 4
Respiratory Distress 4 4
Great Vessel Perforation 4 4
Hypersensitivity/Allergic reaction 4 4
Air Embolism 4 4
Ventricular Tachycardia 4 4
Atrial Perforation 4 4
Prolapse 3 3
Numbness 3 3
Visual Disturbances 3 3
Shock 3 3
Tachycardia 3 3
Heart Failure 3 3
Loss of Vision 3 3
Vomiting 3 3
Thromboembolism 3 3
Loss Of Pulse 3 3
Vascular System (Circulation), Impaired 3 3
Anaphylactic Shock 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 Arrow International Inc II Sep-07-2016
9 Arrow International Inc II Jul-12-2016
10 Boston Scientific Corporation II Feb-20-2019
11 Boston Scientific Corporation II Apr-12-2016
12 Cook Inc. I Nov-03-2020
13 Cook Inc. II Mar-09-2018
14 Cook Inc. I Aug-25-2016
15 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
16 SentreHeart Inc I Nov-09-2016
17 Stryker Neurovascular II Oct-29-2019
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