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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 8
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
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 1087 1087

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1570 2546
Difficult to Remove 1208 1208
Detachment of Device or Device Component 1080 1080
Break 972 972
Fracture 951 951
Difficult to Advance 866 866
Adverse Event Without Identified Device or Use Problem 748 870
Peeled/Delaminated 748 748
Entrapment of Device 527 1503
Failure to Advance 445 445
Material Deformation 375 375
Deformation Due to Compressive Stress 370 370
Unraveled Material 340 340
Stretched 334 334
Physical Resistance/Sticking 311 311
Material Integrity Problem 310 310
Material Split, Cut or Torn 265 265
Improper or Incorrect Procedure or Method 234 234
Insufficient Information 227 227
Material Twisted/Bent 167 167
Product Quality Problem 117 117
Positioning Problem 99 99
Material Frayed 86 86
Device Damaged by Another Device 84 84
Off-Label Use 83 83
Flaked 65 65
Material Fragmentation 64 64
Contamination /Decontamination Problem 59 59
Material Protrusion/Extrusion 55 55
Material Too Soft/Flexible 51 51
Difficult to Insert 50 50
Device Contaminated During Manufacture or Shipping 49 49
Component Misassembled 47 47
Fluid/Blood Leak 46 46
Use of Device Problem 45 45
Unsealed Device Packaging 40 40
Activation, Positioning or Separation Problem 39 39
Defective Device 37 37
Patient Device Interaction Problem 29 29
Device Dislodged or Dislocated 28 28
Device-Device Incompatibility 24 24
Device Contamination with Chemical or Other Material 23 23
Material Too Rigid or Stiff 23 23
Mechanical Jam 22 22
Leak/Splash 21 21
Device Damaged Prior to Use 20 20
Difficult or Delayed Positioning 19 19
Appropriate Term/Code Not Available 19 19
Communication or Transmission Problem 19 19
Device Markings/Labelling Problem 18 18
Obstruction of Flow 18 18
Delivered as Unsterile Product 18 18
Malposition of Device 17 17
Sharp Edges 17 139
No Apparent Adverse Event 15 15
Material Puncture/Hole 15 15
Retraction Problem 15 15
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Crack 14 14
Mechanical Problem 13 13
Material Perforation 13 13
Device Handling Problem 11 11
Tear, Rip or Hole in Device Packaging 11 11
Connection Problem 11 11
Pressure Problem 9 9
Output Problem 9 9
Component Missing 9 9
Packaging Problem 8 8
Infusion or Flow Problem 7 7
Separation Failure 7 7
Defective Component 7 7
Contamination 7 7
Loose or Intermittent Connection 6 6
Gas Output Problem 6 6
Inadequacy of Device Shape and/or Size 6 6
Solder Joint Fracture 6 6
Device Misassembled During Manufacturing /Shipping 6 6
Device Displays Incorrect Message 6 6
Separation Problem 6 6
Difficult or Delayed Activation 5 5
Patient-Device Incompatibility 5 5
Unintended Movement 5 5
Material Rupture 5 5
Overheating of Device 5 5
Device Difficult to Setup or Prepare 5 5
Incorrect Measurement 5 5
Migration or Expulsion of Device 5 5
Accessory Incompatible 5 5
Positioning Failure 4 4
Disconnection 4 4
Degraded 4 4
Scratched Material 4 4
Therapeutic or Diagnostic Output Failure 4 4
Inadequate Lubrication 4 4
Migration 3 3
Human-Device Interface Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Sensing Problem 3 3
Display or Visual Feedback Problem 3 3
Unable to Obtain Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4036 5134
No Consequences Or Impact To Patient 1459 1459
Foreign Body In Patient 1220 1220
Device Embedded In Tissue or Plaque 611 611
Vascular Dissection 465 587
Insufficient Information 400 400
No Known Impact Or Consequence To Patient 354 842
Perforation of Vessels 291 413
Perforation 181 181
No Patient Involvement 169 169
Cardiac Tamponade 136 136
Pericardial Effusion 136 136
Cardiac Perforation 134 134
Low Blood Pressure/ Hypotension 132 132
Vessel Or Plaque, Device Embedded In 105 105
Myocardial Infarction 99 99
No Code Available 97 97
Hemorrhage/Bleeding 95 95
Death 81 81
Obstruction/Occlusion 60 60
Stroke/CVA 49 49
Cardiac Arrest 47 47
Intimal Dissection 47 47
Hematoma 47 47
Pain 46 46
Hemoptysis 41 41
Embolism 38 38
No Information 37 37
Embolism/Embolus 32 32
Thrombosis/Thrombus 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Blood Loss 29 29
Vasoconstriction 29 29
Rupture 26 26
Occlusion 26 26
Intracranial Hemorrhage 25 25
Laceration(s) 22 22
Patient Problem/Medical Problem 22 22
Arrhythmia 19 19
Bradycardia 18 18
Unspecified Tissue Injury 17 17
Unspecified Infection 16 16
High Blood Pressure/ Hypertension 15 15
Injury 15 15
Tachycardia 14 14
Chest Pain 14 14
Extravasation 14 14
Calcium Deposits/Calcification 14 14
Thrombosis 13 13
Thrombus 12 12
Foreign Body Embolism 12 12
Stenosis 11 11
Failure of Implant 11 11
Embolus 10 10
Ventricular Fibrillation 10 10
Transient Ischemic Attack 9 9
Needle Stick/Puncture 9 9
Angina 9 9
Ischemia 9 9
Inflammation 8 8
Atrial Fibrillation 8 8
Pseudoaneurysm 8 8
Cardiogenic Shock 8 8
Discomfort 7 7
Complete Heart Block 7 7
Swelling/ Edema 7 7
Mitral Valve Insufficiency/ Regurgitation 6 6
Heart Block 6 6
Diminished Pulse Pressure 6 6
Great Vessel Perforation 6 6
Aneurysm 6 6
Dyspnea 5 5
Muscle Weakness 5 5
Paralysis 5 5
Respiratory Failure 5 5
Aortic Valve Insufficiency/ Regurgitation 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Valvular Insufficiency/ Regurgitation 4 4
Cough 4 4
Unspecified Nervous System Problem 4 4
Ruptured Aneurysm 4 4
Hemorrhagic Stroke 4 4
Cognitive Changes 4 4
Dysphasia 4 4
Pleural Effusion 4 4
Hypersensitivity/Allergic reaction 4 4
Non specific EKG/ECG Changes 4 4
Bone Fracture(s) 4 4
Headache 4 4
Anaphylactic Shock 3 3
Syncope 3 3
Hypoxia 3 3
Paresis 3 3
Internal Organ Perforation 3 3
Pulmonary Edema 3 3
Rash 3 3
Nausea 3 3
Mitral Regurgitation 3 3
Brain Injury 3 3
Visual Impairment 3 3

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