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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, intravascular, diagnostic
Regulation Description Diagnostic intravascular catheter.
Product CodeDQO
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENTUITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX LTD
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CLINICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 312 312
2021 337 337
2022 379 379
2023 391 391
2024 512 512
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 522 522
Fracture 497 497
Detachment of Device or Device Component 264 264
Difficult to Remove 158 158
Adverse Event Without Identified Device or Use Problem 155 155
Break 129 129
Crack 94 94
Difficult to Advance 61 61
Fluid/Blood Leak 52 52
Material Puncture/Hole 49 49
Material Split, Cut or Torn 48 48
Device Contamination with Chemical or Other Material 41 41
Material Deformation 35 35
Leak/Splash 31 31
Failure to Advance 30 30
Entrapment of Device 28 28
Device Contaminated During Manufacture or Shipping 28 28
Physical Resistance/Sticking 27 27
Material Twisted/Bent 26 26
Deformation Due to Compressive Stress 24 24
Degraded 23 23
Tear, Rip or Hole in Device Packaging 22 22
Communication or Transmission Problem 20 20
Difficult to Insert 19 19
Material Fragmentation 18 18
Material Rupture 18 18
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Gas/Air Leak 16 16
No Display/Image 16 16
Material Integrity Problem 15 15
Unable to Obtain Readings 15 15
Peeled/Delaminated 15 15
Material Frayed 15 15
Device-Device Incompatibility 14 14
Improper or Incorrect Procedure or Method 13 13
Separation Problem 12 12
Poor Quality Image 12 12
Stretched 12 12
Use of Device Problem 10 10
Obstruction of Flow 10 10
Device Damaged by Another Device 9 9
Disconnection 9 9
Burst Container or Vessel 8 8
Structural Problem 8 8
Unraveled Material 8 8
Defective Device 8 8
Contamination 7 7
Contamination /Decontamination Problem 7 7
Material Protrusion/Extrusion 7 7
Deflation Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1236 1236
Foreign Body In Patient 222 222
No Consequences Or Impact To Patient 115 115
Vascular Dissection 77 77
Insufficient Information 59 59
No Known Impact Or Consequence To Patient 39 39
No Patient Involvement 38 38
Thrombosis/Thrombus 30 30
Device Embedded In Tissue or Plaque 29 29
Stroke/CVA 23 23
No Code Available 20 20
Obstruction/Occlusion 19 19
Perforation of Vessels 17 17
Cardiac Arrest 15 15
Chest Pain 13 13
Vasoconstriction 12 12
Hemorrhage/Bleeding 11 11
Non specific EKG/ECG Changes 9 9
Speech Disorder 8 8
Rupture 8 8
Low Blood Pressure/ Hypotension 8 8
Air Embolism 7 7
Ischemia 7 7
Ventricular Fibrillation 7 7
Pericardial Effusion 7 7
Hematoma 7 7
Cardiac Perforation 6 6
Dyspnea 6 6
Death 6 6
Intracranial Hemorrhage 5 5
Failure of Implant 5 5
Cardiac Tamponade 5 5
Paralysis 5 5
Muscle Weakness 5 5
Cardiogenic Shock 5 5
Occlusion 5 5
Hypersensitivity/Allergic reaction 4 4
Thromboembolism 4 4
Renal Failure 4 4
Paresis 4 4
Ischemia Stroke 4 4
Embolism/Embolus 4 4
Arrhythmia 4 4
Angina 4 4
Pain 4 4
Myocardial Infarction 4 4
Tachycardia 3 3
Brain Injury 3 3
Muscle Spasm(s) 3 3
Unspecified Tissue Injury 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Angiodynamics, Inc. II Jul-31-2024
3 Boston Scientific Corporation I May-10-2024
4 Boston Scientific Corporation I Mar-25-2020
5 Cordis Corporation I Sep-15-2021
6 Cordis US Corp I Nov-09-2023
7 Cordis US Corp II Dec-16-2022
8 Stryker Neurovascular II May-28-2024
9 Stryker Neurovascular II Jul-15-2022
10 Stryker, Inc. II Feb-14-2024
11 Vascular Solutions, Inc. I Oct-20-2020
12 Vascular Solutions, Inc. I Apr-27-2020
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