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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
Product CodeDQO
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ACCURATE MEDICAL THERAPEUTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS, A CARDINAL HEALTH COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHENOX LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
SUREFIRE MEDICAL, INC.
  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
2018 777 777
2019 385 385
2020 312 312
2021 337 337
2022 380 380
2023 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 543 543
Material Separation 494 494
Adverse Event Without Identified Device or Use Problem 330 330
Detachment of Device or Device Component 246 246
Failure to Align 160 160
Difficult to Remove 121 121
Break 120 120
Crack 80 80
Retraction Problem 56 56
Tear, Rip or Hole in Device Packaging 56 56
Material Puncture/Hole 49 49
Unintended Movement 37 37
Device Contamination with Chemical or Other Material 35 35
Difficult to Advance 33 33
Fluid/Blood Leak 33 33
Device-Device Incompatibility 29 29
Material Deformation 28 28
Entrapment of Device 28 28
Material Integrity Problem 26 26
Material Twisted/Bent 26 26
Material Split, Cut or Torn 25 25
Detachment Of Device Component 23 23
Material Fragmentation 22 22
Leak/Splash 21 21
Material Rupture 20 20
Occlusion Within Device 18 18
Separation Problem 17 17
Failure to Advance 17 17
Difficult to Insert 16 16
Deformation Due to Compressive Stress 13 13
Communication or Transmission Problem 13 13
Gas/Air Leak 13 13
Packaging Problem 11 11
Migration 11 11
Delivered as Unsterile Product 11 11
Physical Resistance/Sticking 10 10
Component Misassembled 9 9
Device Packaging Compromised 9 9
Unsealed Device Packaging 9 9
Use of Device Problem 9 9
Defective Device 8 8
Contamination /Decontamination Problem 7 7
Device Contaminated During Manufacture or Shipping 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Peeled/Delaminated 7 7
Material Frayed 7 7
No Display/Image 7 7
Poor Quality Image 6 6
Positioning Problem 6 6
Activation, Positioning or Separation Problem 6 6
Structural Problem 6 6
Obstruction of Flow 6 6
Device Damaged by Another Device 5 5
Device Dislodged or Dislocated 5 5
Therapeutic or Diagnostic Output Failure 5 5
Migration or Expulsion of Device 5 5
Stretched 5 5
Unraveled Material 5 5
Flaked 5 5
Partial Blockage 5 5
Deflation Problem 5 5
Burst Container or Vessel 5 5
Complete Blockage 4 4
Improper or Incorrect Procedure or Method 4 4
Inflation Problem 4 4
Air/Gas in Device 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Output Problem 3 3
Device Operates Differently Than Expected 3 3
Calibration Problem 3 3
Material Perforation 3 3
Separation Failure 3 3
Mechanical Problem 3 3
Contamination 3 3
Disconnection 3 3
Flushing Problem 2 2
Loss of or Failure to Bond 2 2
Failure To Adhere Or Bond 2 2
Bent 2 2
Loose or Intermittent Connection 2 2
Device Difficult to Setup or Prepare 2 2
Particulates 2 2
Unable to Obtain Readings 2 2
Device Damaged Prior to Use 2 2
Component Missing 2 2
High Test Results 2 2
Connection Problem 2 2
Device Markings/Labelling Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
No Apparent Adverse Event 2 2
Material Too Soft/Flexible 2 2
Activation Problem 1 1
Inaccurate Information 1 1
Activation Failure 1 1
Noise, Audible 1 1
Torn Material 1 1
Misassembly by Users 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 559 559
No Consequences Or Impact To Patient 408 408
Foreign Body In Patient 277 277
No Known Impact Or Consequence To Patient 155 155
Occlusion 152 152
Perforation of Vessels 148 148
No Patient Involvement 145 145
Thrombosis 104 104
Vascular Dissection 80 80
Perforation 75 75
Device Embedded In Tissue or Plaque 73 73
Vessel Or Plaque, Device Embedded In 70 70
Embolus 70 70
No Code Available 65 65
Coagulation Disorder 44 44
Insufficient Information 36 36
Death 33 33
Pulmonary Embolism 28 28
Pain 26 26
Swelling 25 25
Internal Organ Perforation 20 20
Stenosis 18 18
No Information 17 17
Chest Pain 17 17
Dyspnea 17 17
Embolism 16 16
Hemorrhage/Bleeding 15 15
Stroke/CVA 15 15
Vascular System (Circulation), Impaired 15 15
Injury 12 12
Thrombosis/Thrombus 12 12
Cardiac Arrest 12 12
Low Blood Pressure/ Hypotension 11 11
Anxiety 11 11
Rupture 9 9
Cardiac Perforation 9 9
Thrombus 9 9
Vasoconstriction 9 9
Obstruction/Occlusion 8 8
Pericardial Effusion 7 7
Hematoma 7 7
Air Embolism 7 7
Myocardial Infarction 6 6
Not Applicable 6 6
Blood Loss 6 6
Cardiac Tamponade 6 6
Cardiogenic Shock 6 6
Numbness 5 5
Intracranial Hemorrhage 5 5
Ischemia 4 4
Muscle Spasm(s) 4 4
Intimal Dissection 4 4
Arrhythmia 4 4
Hemorrhage, Cerebral 4 4
Coma 4 4
Thromboembolism 4 4
Bowel Perforation 3 3
Claudication 3 3
Brain Injury 3 3
Depression 3 3
Disability 3 3
Hemoptysis 3 3
Calcium Deposits/Calcification 3 3
Muscle Weakness 3 3
Unspecified Infection 3 3
Renal Failure 3 3
Respiratory Distress 2 2
Transient Ischemic Attack 2 2
Memory Loss/Impairment 2 2
Reocclusion 2 2
Cardiopulmonary Arrest 2 2
Cellulitis 2 2
Angina 2 2
Non specific EKG/ECG Changes 2 2
Edema 2 2
Emotional Changes 2 2
Fistula 2 2
Ulcer 2 2
Loss of Vision 2 2
Pseudoaneurysm 2 2
Atrial Perforation 2 2
Patient Problem/Medical Problem 2 2
Embolism/Embolus 2 2
Foreign Body Embolism 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Ischemia Stroke 1 1
Paresthesia 1 1
Test Result 1 1
Radiation Exposure, Unintended 1 1
Loss of consciousness 1 1
Sweating 1 1
Respiratory Failure 1 1
Aortic Dissection 1 1
Sudden Cardiac Death 1 1
Diminished Pulse Pressure 1 1
Vomiting 1 1
Weakness 1 1
Cramp(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Angiodynamics, Inc. II Feb-13-2018
3 Boston Scientific Corporation I Mar-25-2020
4 Cook Inc. II Nov-18-2019
5 Cordis Corporation I Sep-15-2021
6 Cordis US Corp II Dec-16-2022
7 Medtronic Vascular III Sep-26-2018
8 Medtronic Vascular II Apr-20-2018
9 Numed Inc II Nov-28-2018
10 Stryker Neurovascular II Jul-15-2022
11 Vascular Solutions, Inc. I Oct-20-2020
12 Vascular Solutions, Inc. I Apr-27-2020
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