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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 2
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 389 389
2024 225 225

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 542 542
Fracture 535 535
Detachment of Device or Device Component 292 292
Adverse Event Without Identified Device or Use Problem 184 184
Difficult to Remove 147 147
Break 137 137
Crack 75 75
Material Puncture/Hole 56 56
Difficult to Advance 54 54
Fluid/Blood Leak 41 41
Device Contamination with Chemical or Other Material 38 38
Material Split, Cut or Torn 37 37
Material Deformation 32 32
Device Contaminated During Manufacture or Shipping 28 28
Entrapment of Device 28 28
Failure to Advance 27 27
Material Integrity Problem 27 27
Device-Device Incompatibility 27 27
Material Twisted/Bent 26 26
Physical Resistance/Sticking 24 24
Failure to Align 22 22
Difficult to Insert 22 22
Leak/Splash 21 21
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Deformation Due to Compressive Stress 18 18
Communication or Transmission Problem 17 17
Gas/Air Leak 17 17
Material Rupture 17 17
Tear, Rip or Hole in Device Packaging 17 17
Unable to Obtain Readings 16 16
Separation Problem 15 15
No Display/Image 14 14
Material Fragmentation 13 13
Peeled/Delaminated 13 13
Delivered as Unsterile Product 12 12
Material Frayed 10 10
Stretched 10 10
Defective Device 10 10
Use of Device Problem 9 9
Structural Problem 9 9
Disconnection 9 9
Poor Quality Image 8 8
Obstruction of Flow 8 8
Improper or Incorrect Procedure or Method 8 8
Device Damaged by Another Device 8 8
Positioning Problem 8 8
Contamination /Decontamination Problem 7 7
Migration 7 7
Unraveled Material 7 7
Burst Container or Vessel 7 7
Flaked 6 6
Component Misassembled 6 6
Therapeutic or Diagnostic Output Failure 6 6
Material Too Soft/Flexible 5 5
Unsealed Device Packaging 5 5
Partial Blockage 5 5
Deflation Problem 5 5
Complete Blockage 4 4
Difficult to Flush 4 4
Air/Gas in Device 4 4
Activation, Positioning or Separation Problem 4 4
Device Dislodged or Dislocated 3 3
Connection Problem 3 3
Calibration Problem 3 3
Unintended Movement 3 3
No Apparent Adverse Event 3 3
Material Protrusion/Extrusion 3 3
Packaging Problem 3 3
Activation Failure 3 3
Flushing Problem 3 3
Inflation Problem 3 3
Contamination 3 3
Separation Failure 3 3
Failure to Sense 3 3
Device Difficult to Setup or Prepare 2 2
Component Missing 2 2
High Test Results 2 2
Device Damaged Prior to Use 2 2
Loss of or Failure to Bond 2 2
Degraded 2 2
Difficult or Delayed Positioning 2 2
Mechanical Problem 2 2
Particulates 2 2
Activation Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Output Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Device Markings/Labelling Problem 2 2
Device Displays Incorrect Message 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Misassembly by Users 1 1
Improper Flow or Infusion 1 1
Mechanical Jam 1 1
Inaccurate Information 1 1
Noise, Audible 1 1
Output above Specifications 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 992 992
Foreign Body In Patient 245 245
No Consequences Or Impact To Patient 230 230
No Known Impact Or Consequence To Patient 96 96
Vascular Dissection 90 90
No Patient Involvement 68 68
Insufficient Information 54 54
Device Embedded In Tissue or Plaque 47 47
Perforation of Vessels 44 44
No Code Available 35 35
Thrombosis/Thrombus 18 18
Occlusion 18 18
Cardiac Arrest 18 18
Stroke/CVA 16 16
Death 16 16
Perforation 14 14
Thrombosis 13 13
Obstruction/Occlusion 13 13
Low Blood Pressure/ Hypotension 12 12
Hemorrhage/Bleeding 11 11
Vasoconstriction 11 11
No Information 11 11
Cardiac Perforation 8 8
Rupture 8 8
Chest Pain 8 8
Coagulation Disorder 8 8
Air Embolism 7 7
Pericardial Effusion 7 7
Blood Loss 6 6
Hematoma 6 6
Pulmonary Embolism 6 6
Dyspnea 5 5
Ventricular Fibrillation 5 5
Pain 5 5
Intracranial Hemorrhage 5 5
Cardiogenic Shock 5 5
Paresis 5 5
Cardiac Tamponade 4 4
Injury 4 4
Vascular System (Circulation), Impaired 4 4
Coma 4 4
Thromboembolism 4 4
Ischemia Stroke 4 4
Ischemia 4 4
Muscle Spasm(s) 4 4
Internal Organ Perforation 4 4
Myocardial Infarction 4 4
Renal Failure 4 4
Embolism 4 4
Embolus 4 4
Vessel Or Plaque, Device Embedded In 4 4
Arrhythmia 4 4
Intimal Dissection 3 3
Angina 3 3
Bradycardia 3 3
Calcium Deposits/Calcification 3 3
Encephalopathy 3 3
Hemoptysis 3 3
Thrombus 3 3
Brain Injury 3 3
Muscle Weakness 3 3
Inflammation 3 3
Embolism/Embolus 3 3
Speech Disorder 3 3
Pseudoaneurysm 3 3
Atrial Perforation 2 2
Stenosis 2 2
Not Applicable 2 2
Foreign Body Embolism 2 2
Respiratory Arrest 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
High Blood Pressure/ Hypertension 2 2
Laceration(s) 2 2
Memory Loss/Impairment 2 2
Paralysis 2 2
Loss of Vision 2 2
Swelling 2 2
Tachycardia 2 2
Hemorrhage, Cerebral 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Headache 2 2
Non specific EKG/ECG Changes 2 2
Emotional Changes 1 1
Fistula 1 1
Infiltration into Tissue 1 1
Infarction, Cerebral 1 1
Purulent Discharge 1 1
Aortic Valve Stenosis 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Transient Ischemic Attack 1 1
Respiratory Distress 1 1
Seizures 1 1
Shock 1 1
Dizziness 1 1
Visual Impairment 1 1
Pulmonary Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I May-19-2022
2 Boston Scientific Corporation I May-10-2024
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 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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