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)
2020 2021 2022 2023 2024 2025
0 4 4 5 2 0

MDR Year MDR Reports MDR Events
2021 21 21
2022 57 57
2023 63 888
2024 113 113
2025 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 151 976
Material Split, Cut or Torn 27 27
Material Rupture 21 21
Detachment of Device or Device Component 20 20
Difficult to Remove 19 19
Difficult to Advance 15 15
Off-Label Use 10 10
Insufficient Information 10 10
Entrapment of Device 8 8
Break 7 7
Material Separation 6 6
Sparking 4 4
Failure to Cycle 4 4
Material Puncture/Hole 3 3
No Apparent Adverse Event 3 3
Output Problem 2 2
Deflation Problem 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Inflation Problem 2 2
Partial Blockage 2 2
Activation Failure 2 2
Deformation Due to Compressive Stress 2 2
Burst Container or Vessel 1 1
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Accessory Incompatible 1 1
Intermittent Energy Output 1 1
Collapse 1 1
Unintended Movement 1 1
Unintended Deflation 1 1
Gas/Air Leak 1 1
Decrease in Pressure 1 1
Material Perforation 1 1
Material Deformation 1 1
Retraction Problem 1 1
Failure to Advance 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Myocardial Infarction 57 882
No Clinical Signs, Symptoms or Conditions 50 50
Vascular Dissection 46 542
Cardiac Arrest 37 862
Perforation of Vessels 28 28
Chest Pain 27 27
Perforation 25 850
Insufficient Information 23 23
Thrombosis/Thrombus 19 19
Pericardial Effusion 18 18
Arrhythmia 17 303
Ventricular Fibrillation 16 16
Cardiac Tamponade 15 840
Low Blood Pressure/ Hypotension 13 13
Hematoma 10 10
Foreign Body In Patient 9 9
Obstruction/Occlusion 8 8
Bradycardia 7 7
Hemorrhage/Bleeding 6 6
Pulmonary Edema 6 831
Cardiogenic Shock 6 92
Ischemia Stroke 5 744
Embolism/Embolus 5 5
Atrial Fibrillation 5 5
Stroke/CVA 4 4
Tachycardia 4 4
Asystole 4 4
Angina 4 4
Thromboembolism 3 3
Discomfort 2 2
Low Cardiac Output 2 2
Ischemia 2 2
Sepsis 2 88
Shock 2 2
Pseudoaneurysm 2 2
Air Embolism 2 2
Cardiac Perforation 1 1
Septic Shock 1 1
Cellulitis 1 1
Foreign Body Embolism 1 1
Laceration(s) 1 1
Anemia 1 1
Heart Failure/Congestive Heart Failure 1 1
Calcium Deposits/Calcification 1 1
Extravasation 1 1
Nausea 1 1
Electric Shock 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Endocarditis 1 1

-
-