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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
  SUBSTANTIALLY EQUIVALENT 5
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 5
ACCELLENT INC
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI
  SUBSTANTIALLY EQUIVALENT 11
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 11
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
NANO4IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1463 1463
2017 1523 1523
2018 1733 1733
2019 1677 1677
2020 1480 1480

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 1104 1104
Break 1030 1030
Material Separation 910 910
Detachment Of Device Component 893 893
Peeled/Delaminated 700 700
Adverse Event Without Identified Device or Use Problem 596 596
Fracture 590 590
Detachment of Device or Device Component 589 589
Guidewire 579 579
Entrapment of Device 551 551
Tip 457 457
Difficult to Advance 331 331
Stretched 327 327
Failure to Advance 326 326
Material Deformation 313 313
Material Integrity Problem 253 253
Improper or Incorrect Procedure or Method 228 228
Wire 219 219
Unraveled Material 182 182
Difficult To Position 162 162
Kinked 135 135
Insufficient Information 122 122
Flaked 117 117
Material Fragmentation 115 115
Deformation Due to Compressive Stress 104 104
Device Damaged by Another Device 103 103
Physical Resistance 101 101
Physical Resistance/Sticking 90 90
Material Split, Cut or Torn 88 88
Material Twisted/Bent 83 83
Device Operates Differently Than Expected 80 80
Material Frayed 75 75
Positioning Problem 69 69
Product Quality Problem 64 64
Device Damaged Prior to Use 59 59
Off-Label Use 56 56
Material Protrusion/Extrusion 53 53
Bent 44 44
Catheter 40 40
Device Contamination with Chemical or Other Material 39 39
Difficult to Insert 35 35
Occlusion Within Device 35 35
Material Too Soft/Flexible 34 34
Delamination 33 33
Device Dislodged or Dislocated 33 33
Physical Property Issue 31 31
Torn Material 30 30
Unsealed Device Packaging 30 30
Contamination /Decontamination Problem 27 27
Leak/Splash 25 25
Uncoiled 24 24
Appropriate Term/Code Not Available 23 23
Sticking 22 22
Device Markings/Labelling Problem 21 21
Defective Device 21 21
Fluid Leak 21 21
Mechanical Problem 18 18
Use of Device Problem 17 17
Activation, Positioning or SeparationProblem 16 16
Retraction Problem 15 15
Material Too Rigid or Stiff 14 14
Device Misassembled During Manufacturing /Shipping 14 14
Device Displays Incorrect Message 11 11
Split 11 11
Crack 11 11
Device Or Device Fragments Location Unknown 10 10
Material Distortion 10 10
Difficult or Delayed Positioning 10 10
Structural Problem 9 9
Material Perforation 9 9
Collapse 9 9
Migration or Expulsion of Device 8 8
Filter 8 8
Scratched Material 8 8
Partial Blockage 7 7
Malposition of Device 7 7
Connection Problem 7 7
Component Missing 7 7
Separation Failure 7 7
Cut In Material 6 6
Communication or Transmission Problem 6 6
Device Difficult to Setup or Prepare 6 6
Mechanical Jam 6 6
Packaging Problem 6 6
Defective Component 6 6
Disconnection 6 6
Knotted 5 5
Balloon 5 5
Coil 5 5
Core 5 5
Unable to Obtain Readings 5 5
Tear, Rip or Hole in Device Packaging 5 5
Device-Device Incompatibility 5 5
Compatibility Problem 5 5
Component Misassembled 5 5
Material Torqued 5 5
Human-Device Interface Problem 5 5
Device Issue 5 5
Component or Accessory Incompatibility 4 4
Patient-Device Incompatibility 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3643 3643
No Known Impact Or Consequence To Patient 1002 1002
Device Embedded In Tissue or Plaque 979 979
Foreign Body In Patient 534 534
No Patient Involvement 405 405
Vessel Or Plaque, Device Embedded In 242 242
Death 194 194
Perforation 166 166
No Clinical Signs, Symptoms or Conditions 165 165
No Code Available 146 146
Perforation of Vessels 137 137
Vascular Dissection 114 114
No Information 103 103
Pericardial Effusion 99 99
Intimal Dissection 96 96
Cardiac Tamponade 94 94
Low Blood Pressure/ Hypotension 75 75
Cardiac Perforation 74 74
Patient Problem/Medical Problem 53 53
Blood Loss 45 45
Occlusion 42 42
Embolism 39 39
Hemorrhage/Bleeding 39 39
Cardiac Arrest 34 34
Thrombosis 30 30
Stroke/CVA 29 29
Myocardial Infarction 27 27
Hematoma 23 23
Headache 21 21
Arrhythmia 20 20
Injury 20 20
Rupture 20 20
Thrombus 19 19
Angina 19 19
Vasoconstriction 18 18
Insufficient Information 17 17
Pain 17 17
Tissue Damage 17 17
Unspecified Infection 16 16
Calcium Deposits/Calcification 14 14
Chest Pain 13 13
Embolus 12 12
Aneurysm 12 12
Ischemia 11 11
Hemorrhage, Subarachnoid 11 11
Laceration(s) 10 10
Bradycardia 10 10
Intracranial Hemorrhage 10 10
High Blood Pressure/ Hypertension 10 10
Inflammation 9 9
Complete Heart Block 9 9
Aortic Dissection 9 9
Cardiogenic Shock 9 9
Stenosis 9 9
Obstruction/Occlusion 9 9
Non specific EKG/ECG Changes 8 8
Cardiopulmonary Arrest 7 7
Mitral Regurgitation 7 7
Respiratory Failure 7 7
Pseudoaneurysm 7 7
Ventricular Fibrillation 7 7
Bone Fracture(s) 7 7
Pleural Effusion 6 6
Internal Organ Perforation 6 6
Not Applicable 6 6
ST Segment Elevation 6 6
Sepsis 6 6
Swelling 6 6
Hemorrhage, Cerebral 6 6
Dyspnea 5 5
Neurological Deficit/Dysfunction 5 5
Pneumothorax 5 5
Atrial Fibrillation 5 5
Syncope 5 5
Infarction, Cerebral 4 4
Hemoptysis 4 4
Respiratory Distress 4 4
Discomfort 4 4
Air Embolism 4 4
Extravasation 4 4
Hypersensitivity/Allergic reaction 4 4
Ventricular Tachycardia 4 4
Transient Ischemic Attack 4 4
Atrial Perforation 4 4
Thrombosis/Thrombus 4 4
Visual Disturbances 3 3
Heart Failure 3 3
Loss Of Pulse 3 3
Vascular System (Circulation), Impaired 3 3
Hemothorax 3 3
Hypoxia 2 2
Fistula 2 2
Paralysis 2 2
Abdominal Pain 2 2
Anaphylactic Shock 2 2
Alteration In Body Temperature 2 2
Test Result 2 2
Diminished Pulse Pressure 2 2
Shock 2 2
Tachycardia 2 2

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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