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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 541 541

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1481 2457
Difficult to Remove 1154 1154
Detachment of Device or Device Component 1036 1036
Break 931 931
Fracture 902 902
Difficult to Advance 824 824
Peeled/Delaminated 719 719
Adverse Event Without Identified Device or Use Problem 717 839
Entrapment of Device 508 1484
Failure to Advance 440 440
Deformation Due to Compressive Stress 362 362
Material Deformation 360 360
Unraveled Material 328 328
Stretched 319 319
Physical Resistance/Sticking 303 303
Material Integrity Problem 296 296
Material Split, Cut or Torn 252 252
Improper or Incorrect Procedure or Method 228 228
Insufficient Information 225 225
Material Twisted/Bent 114 114
Product Quality Problem 111 111
Positioning Problem 99 99
Material Frayed 85 85
Off-Label Use 82 82
Device Damaged by Another Device 82 82
Material Fragmentation 62 62
Contamination /Decontamination Problem 56 56
Flaked 55 55
Material Protrusion/Extrusion 54 54
Difficult to Insert 49 49
Material Too Soft/Flexible 48 48
Fluid/Blood Leak 44 44
Use of Device Problem 42 42
Unsealed Device Packaging 39 39
Device Contaminated During Manufacture or Shipping 36 36
Activation, Positioning or Separation Problem 35 35
Defective Device 34 34
Device Dislodged or Dislocated 28 28
Patient Device Interaction Problem 26 26
Device-Device Incompatibility 23 23
Device Contamination with Chemical or Other Material 23 23
Material Too Rigid or Stiff 22 22
Leak/Splash 20 20
Mechanical Jam 20 20
Appropriate Term/Code Not Available 19 19
Communication or Transmission Problem 19 19
Device Damaged Prior to Use 19 19
Delivered as Unsterile Product 18 18
Difficult or Delayed Positioning 18 18
Device Markings/Labelling Problem 18 18
Obstruction of Flow 17 17
Malposition of Device 15 15
Sharp Edges 15 137
Material Puncture/Hole 15 15
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Crack 14 14
No Apparent Adverse Event 14 14
Mechanical Problem 13 13
Retraction Problem 13 13
Material Perforation 12 12
Device Handling Problem 11 11
Connection Problem 10 10
Component Misassembled 9 9
Pressure Problem 9 9
Output Problem 9 9
Tear, Rip or Hole in Device Packaging 9 9
Defective Component 7 7
Packaging Problem 7 7
Infusion or Flow Problem 7 7
Separation Failure 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Device Displays Incorrect Message 6 6
Solder Joint Fracture 6 6
Inadequacy of Device Shape and/or Size 6 6
Loose or Intermittent Connection 6 6
Gas Output Problem 6 6
Separation Problem 6 6
Incorrect Measurement 5 5
Migration or Expulsion of Device 5 5
Contamination 5 5
Accessory Incompatible 5 5
Material Rupture 5 5
Difficult or Delayed Activation 5 5
Patient-Device Incompatibility 5 5
Unintended Movement 5 5
Scratched Material 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Difficult to Setup or Prepare 4 4
Overheating of Device 4 4
Component Missing 4 4
Positioning Failure 4 4
Disconnection 4 4
Degraded 4 4
Inadequate Lubrication 4 4
Display or Visual Feedback Problem 3 3
Failure to Zero 3 3
Unable to Obtain Readings 3 3
Migration 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Sensing Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3649 4747
No Consequences Or Impact To Patient 1458 1458
Foreign Body In Patient 1133 1133
Device Embedded In Tissue or Plaque 599 599
Vascular Dissection 444 566
Insufficient Information 384 384
No Known Impact Or Consequence To Patient 354 842
Perforation of Vessels 281 403
Perforation 176 176
No Patient Involvement 169 169
Cardiac Tamponade 131 131
Pericardial Effusion 130 130
Cardiac Perforation 129 129
Low Blood Pressure/ Hypotension 129 129
Vessel Or Plaque, Device Embedded In 105 105
Myocardial Infarction 99 99
No Code Available 97 97
Hemorrhage/Bleeding 94 94
Death 81 81
Obstruction/Occlusion 59 59
Stroke/CVA 49 49
Intimal Dissection 47 47
Hematoma 47 47
Cardiac Arrest 45 45
Pain 43 43
Hemoptysis 38 38
Embolism 38 38
No Information 37 37
Embolism/Embolus 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Thrombosis/Thrombus 30 30
Blood Loss 29 29
Vasoconstriction 28 28
Rupture 26 26
Occlusion 26 26
Intracranial Hemorrhage 25 25
Patient Problem/Medical Problem 22 22
Laceration(s) 21 21
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
Calcium Deposits/Calcification 14 14
Extravasation 13 13
Chest Pain 13 13
Thrombosis 13 13
Thrombus 12 12
Foreign Body Embolism 12 12
Stenosis 11 11
Ventricular Fibrillation 10 10
Embolus 10 10
Angina 9 9
Failure of Implant 9 9
Ischemia 9 9
Needle Stick/Puncture 9 9
Cardiogenic Shock 8 8
Transient Ischemic Attack 8 8
Inflammation 8 8
Atrial Fibrillation 8 8
Discomfort 7 7
Complete Heart Block 7 7
Pseudoaneurysm 7 7
Swelling/ Edema 7 7
Diminished Pulse Pressure 6 6
Great Vessel Perforation 6 6
Aneurysm 6 6
Dyspnea 5 5
Paralysis 5 5
Muscle Weakness 5 5
Respiratory Failure 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Mitral Valve Insufficiency/ Regurgitation 5 5
Cough 4 4
Heart Block 4 4
Aortic Valve Insufficiency/ Regurgitation 4 4
Hemorrhagic Stroke 4 4
Unspecified Nervous System Problem 4 4
Ruptured Aneurysm 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
Pulmonary Edema 3 3
Rash 3 3
Mitral Regurgitation 3 3
Brain Injury 3 3
Visual Impairment 3 3
Thromboembolism 3 3
Numbness 3 3
Coma 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 Oct-29-2019
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