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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 3
ACCURATE MEDICAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD
  SUBSTANTIALLY EQUIVALENT 1
ACCURATE MEDICAL THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
EMBOLX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENTUITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE, INC.
  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
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
2019 385 385
2020 312 312
2021 337 337
2022 379 379
2023 385 385
2024 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 528 528
Fracture 524 524
Detachment of Device or Device Component 270 270
Adverse Event Without Identified Device or Use Problem 174 174
Difficult to Remove 138 138
Break 130 130
Crack 63 63
Difficult to Advance 52 52
Material Puncture/Hole 51 51
Device Contamination with Chemical or Other Material 33 33
Material Deformation 32 32
Material Split, Cut or Torn 32 32
Fluid/Blood Leak 30 30
Entrapment of Device 28 28
Device Contaminated During Manufacture or Shipping 28 28
Device-Device Incompatibility 27 27
Material Integrity Problem 26 26
Failure to Advance 26 26
Material Twisted/Bent 24 24
Failure to Align 22 22
Difficult to Insert 22 22
Physical Resistance/Sticking 21 21
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Leak/Splash 19 19
Deformation Due to Compressive Stress 18 18
Communication or Transmission Problem 17 17
Material Rupture 17 17
Unable to Obtain Readings 16 16
Tear, Rip or Hole in Device Packaging 16 16
Gas/Air Leak 15 15
Separation Problem 15 15
Material Fragmentation 13 13
Peeled/Delaminated 13 13
Delivered as Unsterile Product 12 12
No Display/Image 12 12
Material Frayed 9 9
Use of Device Problem 9 9
Defective Device 9 9
Positioning Problem 8 8
Structural Problem 8 8
Stretched 8 8
Poor Quality Image 7 7
Obstruction of Flow 7 7
Improper or Incorrect Procedure or Method 7 7
Burst Container or Vessel 7 7
Contamination /Decontamination Problem 7 7
Device Damaged by Another Device 7 7
Migration 7 7
Component Misassembled 6 6
Therapeutic or Diagnostic Output Failure 6 6
Unraveled Material 6 6
Partial Blockage 5 5
Deflation Problem 5 5
Unsealed Device Packaging 5 5
Material Too Soft/Flexible 5 5
Air/Gas in Device 4 4
Activation, Positioning or Separation Problem 4 4
Difficult to Flush 4 4
Disconnection 4 4
Complete Blockage 4 4
Contamination 3 3
Flushing Problem 3 3
Inflation Problem 3 3
Separation Failure 3 3
Failure to Sense 3 3
Connection Problem 3 3
Calibration Problem 3 3
Device Dislodged or Dislocated 3 3
Packaging Problem 3 3
No Apparent Adverse Event 3 3
Material Protrusion/Extrusion 3 3
Unintended Movement 3 3
Activation Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Output Problem 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Activation Failure 2 2
Device Markings/Labelling Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Difficult to Setup or Prepare 2 2
High Test Results 2 2
Component Missing 2 2
Device Damaged Prior to Use 2 2
Mechanical Problem 2 2
Particulates 2 2
Loss of or Failure to Bond 2 2
Difficult or Delayed Positioning 2 2
Material Discolored 1 1
Filling Problem 1 1
Flaked 1 1
Device Alarm System 1 1
Collapse 1 1
Premature Activation 1 1
Output above Specifications 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Defective Component 1 1
Fitting Problem 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 906 906
Foreign Body In Patient 232 232
No Consequences Or Impact To Patient 230 230
No Known Impact Or Consequence To Patient 96 96
Vascular Dissection 89 89
No Patient Involvement 68 68
Insufficient Information 50 50
Device Embedded In Tissue or Plaque 45 45
Perforation of Vessels 44 44
No Code Available 35 35
Occlusion 18 18
Cardiac Arrest 18 18
Thrombosis/Thrombus 17 17
Death 16 16
Stroke/CVA 14 14
Perforation 13 13
Thrombosis 13 13
Low Blood Pressure/ Hypotension 12 12
Hemorrhage/Bleeding 11 11
No Information 11 11
Vasoconstriction 10 10
Obstruction/Occlusion 9 9
Cardiac Perforation 8 8
Rupture 8 8
Chest Pain 8 8
Coagulation Disorder 8 8
Pulmonary Embolism 6 6
Hematoma 6 6
Blood Loss 6 6
Pericardial Effusion 6 6
Cardiogenic Shock 5 5
Dyspnea 5 5
Intracranial Hemorrhage 5 5
Air Embolism 5 5
Ventricular Fibrillation 5 5
Pain 5 5
Internal Organ Perforation 4 4
Paresis 4 4
Ischemia 4 4
Muscle Spasm(s) 4 4
Myocardial Infarction 4 4
Renal Failure 4 4
Arrhythmia 4 4
Vessel Or Plaque, Device Embedded In 4 4
Embolism 4 4
Embolus 4 4
Injury 4 4
Coma 4 4
Vascular System (Circulation), Impaired 4 4
Cardiac Tamponade 4 4
Ischemia Stroke 3 3
Pseudoaneurysm 3 3
Thromboembolism 3 3
Encephalopathy 3 3
Intimal Dissection 3 3
Bradycardia 3 3
Calcium Deposits/Calcification 3 3
Angina 3 3
Thrombus 3 3
Brain Injury 3 3
Muscle Weakness 3 3
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Headache 2 2
High Blood Pressure/ Hypertension 2 2
Inflammation 2 2
Paralysis 2 2
Loss of Vision 2 2
Swelling 2 2
Tachycardia 2 2
Hemoptysis 2 2
Non specific EKG/ECG Changes 2 2
Hemorrhage, Cerebral 2 2
Failure of Implant 2 2
Atrial Perforation 2 2
Stenosis 2 2
Not Applicable 2 2
Respiratory Arrest 2 2
Embolism/Embolus 2 2
Foreign Body Embolism 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Speech Disorder 2 2
Unspecified Tissue Injury 2 2
Cramp(s) /Muscle Spasm(s) 1 1
Radiation Exposure, Unintended 1 1
Test Result 1 1
Patient Problem/Medical Problem 1 1
Paresthesia 1 1
Convulsion/Seizure 1 1
Movement Disorder 1 1
Anxiety 1 1
Discomfort 1 1
Loss of consciousness 1 1
Reaction 1 1
Diminished Pulse Pressure 1 1
Unspecified Infection 1 1
Infiltration into Tissue 1 1
Hemorrhage, Subarachnoid 1 1
Emotional Changes 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Boston Scientific Corporation I Mar-25-2020
3 Cook Inc. II Nov-18-2019
4 Cordis Corporation I Sep-15-2021
5 Cordis US Corp I Nov-09-2023
6 Cordis US Corp II Dec-16-2022
7 Stryker Neurovascular II Jul-15-2022
8 Stryker, Inc. II Feb-14-2024
9 Vascular Solutions, Inc. I Oct-20-2020
10 Vascular Solutions, Inc. I Apr-27-2020
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