• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 8
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  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 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 1
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 2
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 179 179

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1423 2399
Difficult to Remove 1114 1114
Detachment of Device or Device Component 1003 1003
Break 914 914
Fracture 872 872
Difficult to Advance 779 779
Peeled/Delaminated 696 696
Adverse Event Without Identified Device or Use Problem 686 808
Entrapment of Device 496 1472
Failure to Advance 428 428
Deformation Due to Compressive Stress 357 357
Material Deformation 336 336
Unraveled Material 317 317
Stretched 307 307
Physical Resistance/Sticking 291 291
Material Integrity Problem 286 286
Material Split, Cut or Torn 237 237
Improper or Incorrect Procedure or Method 225 225
Insufficient Information 209 209
Product Quality Problem 110 110
Material Twisted/Bent 99 99
Positioning Problem 94 94
Material Frayed 85 85
Device Damaged by Another Device 80 80
Off-Label Use 76 76
Material Fragmentation 62 62
Flaked 54 54
Contamination /Decontamination Problem 53 53
Material Protrusion/Extrusion 52 52
Difficult to Insert 49 49
Material Too Soft/Flexible 45 45
Fluid/Blood Leak 43 43
Use of Device Problem 41 41
Unsealed Device Packaging 39 39
Activation, Positioning or Separation Problem 35 35
Defective Device 34 34
Device Contaminated During Manufacture or Shipping 34 34
Device Dislodged or Dislocated 28 28
Patient Device Interaction Problem 25 25
Device Contamination with Chemical or Other Material 23 23
Device-Device Incompatibility 21 21
Mechanical Jam 20 20
Material Too Rigid or Stiff 20 20
Leak/Splash 20 20
Communication or Transmission Problem 19 19
Delivered as Unsterile Product 18 18
Difficult or Delayed Positioning 18 18
Device Damaged Prior to Use 18 18
Device Markings/Labelling Problem 17 17
Appropriate Term/Code Not Available 17 17
No Apparent Adverse Event 14 14
Malposition of Device 14 14
Obstruction of Flow 14 14
Material Puncture/Hole 14 14
Crack 14 14
Sharp Edges 13 135
Mechanical Problem 12 12
Retraction Problem 12 12
Material Perforation 12 12
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Device Handling Problem 10 10
Connection Problem 10 10
Tear, Rip or Hole in Device Packaging 9 9
Output Problem 9 9
Component Misassembled 8 8
Infusion or Flow Problem 7 7
Separation Failure 7 7
Defective Component 7 7
Inadequacy of Device Shape and/or Size 6 6
Loose or Intermittent Connection 6 6
Gas Output Problem 6 6
Device Displays Incorrect Message 6 6
Device Misassembled During Manufacturing /Shipping 6 6
Packaging Problem 6 6
Separation Problem 6 6
Unintended Movement 5 5
Difficult or Delayed Activation 5 5
Patient-Device Incompatibility 5 5
Migration or Expulsion of Device 5 5
Contamination 5 5
Accessory Incompatible 5 5
Material Rupture 5 5
Solder Joint Fracture 5 5
Component Missing 4 4
Overheating of Device 4 4
Device Difficult to Setup or Prepare 4 4
Disconnection 4 4
Degraded 4 4
Positioning Failure 4 4
Therapeutic or Diagnostic Output Failure 4 4
Inadequate Lubrication 4 4
Migration 3 3
Scratched Material 3 3
Pressure Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Sensing Problem 3 3
Human-Device Interface Problem 3 3
Display or Visual Feedback Problem 3 3
Unable to Obtain Readings 3 3
Failure to Zero 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3443 4541
No Consequences Or Impact To Patient 1458 1458
Foreign Body In Patient 1059 1059
Device Embedded In Tissue or Plaque 590 590
Vascular Dissection 419 541
Insufficient Information 374 374
No Known Impact Or Consequence To Patient 354 842
Perforation of Vessels 263 385
Perforation 173 173
No Patient Involvement 169 169
Pericardial Effusion 127 127
Cardiac Perforation 126 126
Low Blood Pressure/ Hypotension 126 126
Cardiac Tamponade 120 120
Vessel Or Plaque, Device Embedded In 105 105
No Code Available 97 97
Myocardial Infarction 92 92
Hemorrhage/Bleeding 89 89
Death 81 81
Obstruction/Occlusion 55 55
Intimal Dissection 47 47
Hematoma 45 45
Cardiac Arrest 44 44
Stroke/CVA 42 42
Pain 40 40
Embolism 38 38
No Information 37 37
Hemoptysis 32 32
Embolism/Embolus 30 30
Blood Loss 29 29
Thrombosis/Thrombus 28 28
Vasoconstriction 27 27
Occlusion 26 26
Intracranial Hemorrhage 25 25
Rupture 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Patient Problem/Medical Problem 22 22
Laceration(s) 19 19
Arrhythmia 19 19
Bradycardia 17 17
Unspecified Tissue Injury 17 17
High Blood Pressure/ Hypertension 15 15
Unspecified Infection 15 15
Injury 15 15
Tachycardia 14 14
Calcium Deposits/Calcification 14 14
Extravasation 13 13
Thrombosis 13 13
Thrombus 12 12
Chest Pain 12 12
Foreign Body Embolism 12 12
Stenosis 11 11
Ventricular Fibrillation 10 10
Embolus 10 10
Angina 9 9
Ischemia 9 9
Inflammation 8 8
Failure of Implant 8 8
Atrial Fibrillation 8 8
Transient Ischemic Attack 8 8
Needle Stick/Puncture 8 8
Cardiogenic Shock 8 8
Complete Heart Block 7 7
Swelling/ Edema 7 7
Pseudoaneurysm 6 6
Diminished Pulse Pressure 6 6
Discomfort 6 6
Aneurysm 6 6
Dyspnea 5 5
Paralysis 5 5
Respiratory Failure 5 5
Muscle Weakness 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Mitral Valve Insufficiency/ Regurgitation 5 5
Heart Block 4 4
Aortic Valve Insufficiency/ Regurgitation 4 4
Hemorrhagic Stroke 4 4
Unspecified Nervous System Problem 4 4
Ruptured Aneurysm 4 4
Dysphasia 4 4
Great Vessel Perforation 4 4
Cognitive Changes 4 4
Pleural Effusion 4 4
Hypersensitivity/Allergic reaction 4 4
Non specific EKG/ECG Changes 4 4
Bone Fracture(s) 4 4
Headache 3 3
Anaphylactic Shock 3 3
Syncope 3 3
Hypoxia 3 3
Paresis 3 3
Pulmonary Edema 3 3
Mitral Regurgitation 3 3
Thromboembolism 3 3
Numbness 3 3
Coma 3 3
Brain Injury 3 3
Visual Impairment 3 3
Arteriosclerosis/ Atherosclerosis 3 3
Speech Disorder 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 Boston Scientific Corporation II Feb-20-2019
5 Cook Inc. I Nov-03-2020
6 Cook Incorporated II Sep-28-2022
7 Cook Incorporated II Sep-09-2022
8 Stryker Neurovascular II Oct-29-2019
-
-