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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 4
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 9
EMBRACE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
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
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VESATEK, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1736 1736
2019 1677 1677
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 1407 1407

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1514 2490
Difficult to Remove 1254 1254
Break 1113 1113
Detachment of Device or Device Component 1086 1086
Fracture 891 891
Peeled/Delaminated 781 781
Adverse Event Without Identified Device or Use Problem 741 863
Difficult to Advance 728 728
Entrapment of Device 584 1560
Failure to Advance 469 469
Stretched 385 385
Material Deformation 379 379
Unraveled Material 335 335
Deformation Due to Compressive Stress 320 320
Material Integrity Problem 316 316
Improper or Incorrect Procedure or Method 267 267
Physical Resistance/Sticking 260 260
Material Split, Cut or Torn 215 215
Insufficient Information 211 211
Detachment Of Device Component 197 197
Material Twisted/Bent 119 119
Product Quality Problem 115 115
Material Frayed 103 103
Positioning Problem 101 101
Device Damaged by Another Device 95 95
Material Fragmentation 85 85
Off-Label Use 84 84
Material Protrusion/Extrusion 80 80
Flaked 74 74
Fluid/Blood Leak 54 54
Contamination /Decontamination Problem 53 53
Difficult to Insert 52 52
Material Too Soft/Flexible 48 48
Unsealed Device Packaging 40 40
Difficult To Position 40 40
Device Dislodged or Dislocated 40 40
Use of Device Problem 38 38
Device Damaged Prior to Use 38 38
Defective Device 37 37
Device Contamination with Chemical or Other Material 37 37
Kinked 37 37
Activation, Positioning or Separation Problem 36 36
Appropriate Term/Code Not Available 29 29
Device Operates Differently Than Expected 26 26
Leak/Splash 24 24
Physical Resistance 22 22
Device-Device Incompatibility 21 21
Device Contaminated During Manufacture or Shipping 21 21
Patient Device Interaction Problem 21 21
Mechanical Jam 20 20
Device Markings/Labelling Problem 20 20
Bent 20 20
Difficult or Delayed Positioning 20 20
Delivered as Unsterile Product 20 20
Mechanical Problem 19 19
Crack 18 18
Communication or Transmission Problem 18 18
Retraction Problem 16 16
Material Too Rigid or Stiff 16 16
Malposition of Device 15 15
Obstruction of Flow 15 15
Material Perforation 14 14
Material Puncture/Hole 13 13
No Apparent Adverse Event 13 13
Torn Material 11 11
Sharp Edges 11 133
Connection Problem 11 11
Uncoiled 10 10
Device Displays Incorrect Message 10 10
Structural Problem 10 10
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Device Handling Problem 10 10
Output Problem 9 9
Tear, Rip or Hole in Device Packaging 9 9
Delamination 9 9
Loose or Intermittent Connection 8 8
Packaging Problem 8 8
Scratched Material 7 7
Separation Problem 7 7
Migration or Expulsion of Device 7 7
Infusion or Flow Problem 7 7
Defective Component 7 7
Separation Failure 7 7
Patient-Device Incompatibility 7 7
Split 6 6
Component Missing 6 6
Inadequacy of Device Shape and/or Size 6 6
Gas Output Problem 6 6
Contamination 6 6
Degraded 5 5
Accessory Incompatible 5 5
Material Rupture 5 5
Solder Joint Fracture 5 5
Difficult or Delayed Activation 5 5
Component Misassembled 5 5
Physical Property Issue 5 5
Unintended Movement 5 5
Therapeutic or Diagnostic Output Failure 4 4
Inadequate Lubrication 4 4
Failure to Zero 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2906 4004
No Consequences Or Impact To Patient 2290 2290
Foreign Body In Patient 1032 1032
Device Embedded In Tissue or Plaque 770 770
No Known Impact Or Consequence To Patient 610 1098
Vascular Dissection 390 512
Insufficient Information 358 358
No Patient Involvement 283 283
Perforation of Vessels 237 359
Perforation 180 180
Vessel Or Plaque, Device Embedded In 157 157
Pericardial Effusion 138 138
No Code Available 134 134
Cardiac Perforation 132 132
Low Blood Pressure/ Hypotension 130 130
Cardiac Tamponade 120 120
Death 117 117
Hemorrhage/Bleeding 92 92
Intimal Dissection 68 68
Myocardial Infarction 58 58
No Information 56 56
Cardiac Arrest 45 45
Hematoma 43 43
Embolism 41 41
Pain 41 41
Obstruction/Occlusion 39 39
Stroke/CVA 39 39
Blood Loss 37 37
Patient Problem/Medical Problem 32 32
Occlusion 30 30
Rupture 30 30
Hemoptysis 29 29
Thrombosis/Thrombus 27 27
Embolism/Embolus 26 26
Intracranial Hemorrhage 26 26
Vasoconstriction 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Laceration(s) 20 20
Arrhythmia 20 20
Bradycardia 19 19
Thrombosis 18 18
Angina 17 17
Unspecified Tissue Injury 17 17
Calcium Deposits/Calcification 16 16
Chest Pain 16 16
Injury 16 16
Cardiogenic Shock 15 15
Thrombus 15 15
Unspecified Infection 15 15
Extravasation 13 13
Tachycardia 12 12
Foreign Body Embolism 12 12
Stenosis 11 11
Ischemia 11 11
High Blood Pressure/ Hypertension 11 11
Embolus 10 10
Aneurysm 10 10
Ventricular Fibrillation 10 10
Atrial Fibrillation 9 9
Inflammation 8 8
Transient Ischemic Attack 8 8
Needle Stick/Puncture 7 7
Discomfort 7 7
Bone Fracture(s) 7 7
Dyspnea 7 7
Diminished Pulse Pressure 7 7
Complete Heart Block 7 7
Swelling/ Edema 6 6
Non specific EKG/ECG Changes 6 6
Hemorrhage, Subarachnoid 6 6
Failure of Implant 6 6
Pleural Effusion 6 6
Respiratory Failure 6 6
Tissue Damage 6 6
Paralysis 5 5
Muscle Weakness 5 5
Air Embolism 5 5
Syncope 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Mitral Valve Insufficiency/ Regurgitation 5 5
Pseudoaneurysm 5 5
Heart Block 4 4
Hemorrhagic Stroke 4 4
Unspecified Nervous System Problem 4 4
Ruptured Aneurysm 4 4
Aortic Valve Insufficiency/ Regurgitation 4 4
Mitral Regurgitation 4 4
Pneumothorax 4 4
Hypoxia 4 4
Hypersensitivity/Allergic reaction 4 4
Headache 4 4
Paresis 4 4
Sepsis 4 4
Shock 4 4
Dysphasia 4 4
Great Vessel Perforation 4 4
Low Cardiac Output 4 4
Cognitive Changes 4 4
Loss Of Pulse 3 3
Numbness 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 Boston Scientific Corporation II Feb-20-2019
8 Cook Inc. I Nov-03-2020
9 Cook Inc. II Mar-09-2018
10 Cook Incorporated II Sep-28-2022
11 Cook Incorporated II Sep-09-2022
12 Stryker Neurovascular II Oct-29-2019
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