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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device wire, guide, catheter
Regulation Description Catheter guide wire.
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
ASAHI INTECC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERICS NLE
  SUBSTANTIALLY EQUIVALENT 2
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTURION MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
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
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEVEN SONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
2020 1536 2024
2021 1712 3054
2022 1647 1647
2023 2068 2068
2024 2218 2218
2025 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1444 2420
Difficult to Remove 1120 1120
Fracture 954 954
Detachment of Device or Device Component 897 897
Difficult to Advance 882 882
Break 831 831
Adverse Event Without Identified Device or Use Problem 724 846
Peeled/Delaminated 700 700
Entrapment of Device 474 1450
Failure to Advance 420 420
Deformation Due to Compressive Stress 365 365
Unraveled Material 352 352
Material Deformation 327 327
Physical Resistance/Sticking 303 303
Stretched 291 291
Material Split, Cut or Torn 284 284
Material Integrity Problem 265 265
Insufficient Information 247 247
Material Twisted/Bent 238 238
Improper or Incorrect Procedure or Method 205 205
Positioning Problem 94 94
Product Quality Problem 91 91
Incorrect Measurement 85 85
Material Frayed 74 74
Device Damaged by Another Device 67 67
Off-Label Use 60 60
Device Contaminated During Manufacture or Shipping 54 54
Material Fragmentation 54 54
Material Protrusion/Extrusion 54 54
Flaked 52 52
Contamination /Decontamination Problem 48 48
Fluid/Blood Leak 47 47
Component Misassembled 47 47
Use of Device Problem 44 44
Difficult to Insert 41 41
Material Too Soft/Flexible 40 40
Defective Device 34 34
Activation, Positioning or Separation Problem 34 34
Patient Device Interaction Problem 33 33
Leak/Splash 32 32
Mechanical Jam 27 27
Device Dislodged or Dislocated 23 23
Device-Device Incompatibility 23 23
Obstruction of Flow 22 22
Unsealed Device Packaging 20 20
Delivered as Unsterile Product 20 20
Communication or Transmission Problem 20 20
Difficult or Delayed Positioning 20 20
Device Contamination with Chemical or Other Material 18 18
Sharp Edges 18 140

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4887 5985
Foreign Body In Patient 1249 1249
No Consequences Or Impact To Patient 662 662
Vascular Dissection 517 639
Device Embedded In Tissue or Plaque 437 437
Insufficient Information 434 434
Perforation of Vessels 323 445
Perforation 160 160
Cardiac Tamponade 144 144
No Known Impact Or Consequence To Patient 142 630
Cardiac Perforation 140 140
Low Blood Pressure/ Hypotension 134 134
Pericardial Effusion 126 126
Hemorrhage/Bleeding 114 114
Myocardial Infarction 112 112
Obstruction/Occlusion 76 76
No Patient Involvement 61 61
Vessel Or Plaque, Device Embedded In 59 59
Hemoptysis 59 59
Hematoma 53 53
Pain 47 47
Embolism/Embolus 47 47
Stroke/CVA 45 45
Death 45 45
No Code Available 44 44
Cardiac Arrest 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Thrombosis/Thrombus 33 33
Intimal Dissection 32 32
Intracranial Hemorrhage 27 27
Embolism 26 26
Vasoconstriction 26 26
Laceration(s) 21 21
Unspecified Tissue Injury 20 20
Rupture 19 19
Occlusion 19 19
Bradycardia 17 17
Chest Pain 16 16
High Blood Pressure/ Hypertension 15 15
Extravasation 15 15
Blood Loss 15 15
Tachycardia 15 15
Arrhythmia 14 14
Cardiomyopathy 14 14
No Information 14 14
Foreign Body Embolism 12 12
Failure of Implant 12 12
Unspecified Infection 12 12
Calcium Deposits/Calcification 11 11
Stenosis 10 10

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. II Sep-26-2024
2 ARROW INTERNATIONAL Inc. I Mar-21-2024
3 Argon Medical Devices, Inc I May-07-2020
4 Arrow International Inc II Jan-23-2020
5 Bard Peripheral Vascular Inc II Sep-06-2024
6 Cook Inc. I Nov-03-2020
7 Cook Incorporated II Nov-21-2024
8 Cook Incorporated II Nov-08-2024
9 Cook Incorporated II Sep-28-2022
10 Cook Incorporated II Sep-09-2022
11 Stryker Neurovascular II May-31-2024
12 Stryker Neurovascular II May-28-2024
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