Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device shockwave intravascular lithotripsy system
Definition Dilatation of coronary arteries prior to stenting
Product CodeQMG
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 0 4 4 5 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 57 57
2023 63 888
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 63 888
Material Rupture 21 21
Difficult to Remove 16 16
Detachment of Device or Device Component 13 13
Insufficient Information 9 9
Entrapment of Device 8 8
Difficult to Advance 8 8
Break 7 7
Material Separation 6 6
Off-Label Use 6 6
Sparking 4 4
Material Split, Cut or Torn 3 3
Material Puncture/Hole 3 3
Deflation Problem 2 2
Use of Device Problem 2 2
Deformation Due to Compressive Stress 2 2
Activation Failure 2 2
Failure to Cycle 2 2
Material Twisted/Bent 2 2
Inflation Problem 2 2
Partial Blockage 2 2
Output Problem 2 2
Material Perforation 1 1
Mechanical Problem 1 1
Collapse 1 1
Unintended Movement 1 1
Accessory Incompatible 1 1
Decrease in Pressure 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Burst Container or Vessel 1 1
Gas/Air Leak 1 1
Failure to Advance 1 1
Unexpected Therapeutic Results 1 1
Intermittent Energy Output 1 1
No Apparent Adverse Event 1 1
Unintended Deflation 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
Vascular Dissection 26 522
Perforation 22 847
Cardiac Arrest 21 846
Insufficient Information 16 16
Myocardial Infarction 13 838
Perforation of Vessels 11 11
Cardiac Tamponade 10 835
Arrhythmia 10 296
Pericardial Effusion 9 9
Thrombosis/Thrombus 9 9
Foreign Body In Patient 8 8
Chest Pain 6 6
Pulmonary Edema 6 831
Hematoma 5 5
Low Blood Pressure/ Hypotension 5 5
Cardiogenic Shock 5 91
Ventricular Fibrillation 5 5
Ischemia Stroke 5 744
Angina 4 4
Hemorrhage/Bleeding 4 4
Stroke/CVA 3 3
Bradycardia 3 3
Air Embolism 2 2
Sepsis 2 88
Tachycardia 2 2
Discomfort 2 2
Obstruction/Occlusion 2 2
Low Cardiac Output 2 2
Embolism/Embolus 2 2
Asystole 2 2
Unspecified Tissue Injury 1 1
Restenosis 1 1
Foreign Body Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiac Perforation 1 1
Electric Shock 1 1
Thromboembolism 1 1
Low Oxygen Saturation 1 1
Device Embedded In Tissue or Plaque 1 1
Ventilator Dependent 1 1
Nausea 1 1
Ischemia 1 1
Laceration(s) 1 1
Abdominal Pain 1 1
Non specific EKG/ECG Changes 1 1
Extravasation 1 1

-
-