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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 7
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 7
ACCELLENT INC
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI
  SUBSTANTIALLY EQUIVALENT 12
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
BOSTON SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  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
NEEDLETECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 6
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1322 1322
2016 1463 1463
2017 1523 1523
2018 1733 1733
2019 1677 1677
2020 1058 1058

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 1255 1255
Detachment Of Device Component 1201 1201
Break 1145 1145
Material Separation 865 865
Peeled/Delaminated 807 807
Guidewire 772 772
Fracture 657 657
Adverse Event Without Identified Device or Use Problem 625 625
Entrapment of Device 623 623
Tip 621 621
Detachment of Device or Device Component 582 582
Stretched 387 387
Failure to Advance 371 371
Difficult to Advance 327 327
Material Deformation 321 321
Improper or Incorrect Procedure or Method 261 261
Wire 258 258
Material Integrity Problem 256 256
Difficult To Position 243 243
Unraveled Material 214 214
Kinked 181 181
Physical Resistance 143 143
Device Damaged by Another Device 136 136
Material Fragmentation 132 132
Insufficient Information 118 118
Flaked 117 117
Device Operates Differently Than Expected 103 103
Deformation Due to Compressive Stress 90 90
Material Frayed 83 83
Physical Resistance/Sticking 82 82
Material Split, Cut or Torn 81 81
Material Twisted/Bent 78 78
Bent 73 73
Positioning Problem 72 72
Device Damaged Prior to Use 70 70
Product Quality Problem 63 63
Material Protrusion/Extrusion 59 59
Off-Label Use 52 52
Device Contamination with Chemical or Other Material 44 44
Catheter 43 43
Physical Property Issue 42 42
Difficult to Insert 42 42
Delamination 39 39
Torn Material 37 37
Device Dislodged or Dislocated 36 36
Leak/Splash 35 35
Occlusion Within Device 35 35
Unsealed Device Packaging 30 30
Material Too Soft/Flexible 30 30
Sticking 29 29
Uncoiled 27 27
Contamination /Decontamination Problem 26 26
Appropriate Term/Code Not Available 24 24
Device Markings/Labelling Problem 24 24
Device Misassembled During Manufacturing /Shipping 22 22
Fluid Leak 22 22
Use of Device Problem 21 21
Defective Device 20 20
Mechanical Problem 18 18
Activation, Positioning or SeparationProblem 17 17
Split 16 16
Material Too Rigid or Stiff 15 15
Migration or Expulsion of Device 15 15
Retraction Problem 14 14
Device Displays Incorrect Message 14 14
Material Distortion 14 14
Crack 13 13
Device Or Device Fragments Location Unknown 11 11
Material Perforation 10 10
Collapse 10 10
Unable to Obtain Readings 9 9
Structural Problem 9 9
Scratched Material 9 9
Material Torqued 8 8
Cut In Material 8 8
Device Difficult to Setup or Prepare 8 8
Difficult or Delayed Positioning 8 8
Filter 8 8
Partial Blockage 7 7
Tear, Rip or Hole in Device Packaging 7 7
Component Missing 7 7
Malposition of Device 7 7
Connection Problem 7 7
Patient-Device Incompatibility 6 6
Device Issue 6 6
Defective Component 6 6
Component Falling 6 6
Coil 6 6
Core 6 6
Balloon 6 6
Degraded 6 6
Disconnection 6 6
Device Expiration Issue 6 6
Mechanical Jam 6 6
Packaging Problem 6 6
Human-Device Interface Problem 6 6
Compatibility Problem 5 5
Device Packaging Compromised 5 5
Device-Device Incompatibility 5 5
Pressure Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4191 4191
No Known Impact Or Consequence To Patient 1141 1141
Device Embedded In Tissue or Plaque 1101 1101
Foreign Body In Patient 605 605
No Patient Involvement 467 467
Vessel Or Plaque, Device Embedded In 265 265
Death 233 233
No Code Available 162 162
Perforation 161 161
Perforation of Vessels 144 144
No Information 132 132
Vascular Dissection 114 114
Pericardial Effusion 111 111
Intimal Dissection 92 92
Cardiac Tamponade 84 84
Low Blood Pressure/ Hypotension 77 77
Cardiac Perforation 73 73
Patient Problem/Medical Problem 55 55
Blood Loss 49 49
Thrombosis 40 40
Cardiac Arrest 35 35
Stroke/CVA 30 30
Hemorrhage/Bleeding 30 30
Occlusion 30 30
Embolism 26 26
No Clinical Signs, Symptoms or Conditions 26 26
Hematoma 24 24
Rupture 24 24
Injury 22 22
Headache 22 22
Thrombus 21 21
Hemorrhage, Subarachnoid 20 20
Arrhythmia 20 20
Angina 18 18
Pain 17 17
Tissue Damage 17 17
Chest Pain 16 16
Myocardial Infarction 14 14
Cardiogenic Shock 14 14
Vasoconstriction 13 13
Hemorrhage, Cerebral 13 13
Embolus 13 13
Aneurysm 13 13
Calcium Deposits/Calcification 12 12
Laceration(s) 12 12
Aortic Dissection 12 12
Bradycardia 11 11
Intracranial Hemorrhage 10 10
Ischemia 10 10
Obstruction/Occlusion 10 10
Complete Heart Block 10 10
Stenosis 9 9
Inflammation 9 9
Non specific EKG/ECG Changes 9 9
Unspecified Infection 8 8
Respiratory Failure 8 8
Pseudoaneurysm 7 7
Ventricular Fibrillation 7 7
ST Segment Elevation 7 7
Sepsis 7 7
Swelling 7 7
Mitral Regurgitation 7 7
Neurological Deficit/Dysfunction 7 7
Bone Fracture(s) 7 7
Cardiopulmonary Arrest 7 7
Infarction, Cerebral 6 6
Pleural Effusion 6 6
Internal Organ Perforation 6 6
Ventricular Tachycardia 6 6
Not Applicable 6 6
Respiratory Distress 5 5
Loss Of Pulse 5 5
Pneumothorax 5 5
Atrial Fibrillation 5 5
Syncope 5 5
Fistula 5 5
Dyspnea 5 5
Extravasation 4 4
Hemoptysis 4 4
Air Embolism 4 4
Hemothorax 4 4
High Blood Pressure/ Hypertension 4 4
Heart Failure 4 4
Discomfort 4 4
Transient Ischemic Attack 4 4
Nonresorbable materials, unretrieved in body 4 4
Vascular System (Circulation), Impaired 4 4
Hydrocephalus 3 3
Missing Value Reason 3 3
Visual Disturbances 3 3
Surgical procedure, additional 3 3
Atrial Perforation 3 3
Paralysis 3 3
Renal Failure 2 2
Hypoxia 2 2
Infiltration into Tissue 2 2
Anaphylactic Shock 2 2
Anemia 2 2
Abdominal Pain 2 2
Atrial Flutter 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 Baylis Medical Corp * II Dec-01-2015
11 Baylis Medical Corp * II Apr-13-2015
12 Boston Scientific Corporation II Feb-20-2019
13 Boston Scientific Corporation II Apr-12-2016
14 Cook Inc. II Mar-09-2018
15 Cook Inc. I Aug-25-2016
16 EXP Pharmaceutical Services Corp II Jul-24-2015
17 Merit Medical Systems, Inc. II Jun-26-2015
18 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
19 SentreHeart Inc I Nov-09-2016
20 Stryker Neurovascular II Oct-29-2019
21 Volcano Corporation II Jun-25-2015
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