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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous catheter, ultrasound
Definition Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Product CodePPN
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
SHOCKWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 7 7
2020 16 16
2021 18 18
2022 35 35
2023 30 30
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 45 45
Material Split, Cut or Torn 40 40
Material Separation 31 31
Difficult to Remove 29 29
Adverse Event Without Identified Device or Use Problem 24 24
Material Rupture 20 20
Off-Label Use 12 12
Entrapment of Device 5 5
Material Fragmentation 4 4
Deflation Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Device 2 2
Break 2 2
Material Puncture/Hole 2 2
Inflation Problem 1 1
Device Alarm System 1 1
Display or Visual Feedback Problem 1 1
Activation, Positioning or Separation Problem 1 1
Separation Failure 1 1
Retraction Problem 1 1
Use of Device Problem 1 1
Intermittent Communication Failure 1 1
Failure to Deflate 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Insufficient Information 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Peripheral Vascular Disease 12 12
Foreign Body In Patient 12 12
Vascular Dissection 5 5
Perforation of Vessels 4 4
Perforation 4 4
Insufficient Information 4 4
Retroperitoneal Hemorrhage 3 3
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 3 3
Pain 2 2
Cardiac Arrest 2 2
Mitral Perforation 2 2
Device Embedded In Tissue or Plaque 2 2
Hemorrhagic Stroke 2 2
Obstruction/Occlusion 2 2
Restenosis 2 2
Foreign Body Embolism 2 2
Thrombosis/Thrombus 1 1
Swelling/ Edema 1 1
Spinal Cord Injury 1 1
Post Operative Wound Infection 1 1
Low Oxygen Saturation 1 1
Ischemic Heart Disease 1 1
Blurred Vision 1 1
No Consequences Or Impact To Patient 1 1
Viral Infection 1 1
Cardiogenic Shock 1 1
Stenosis 1 1
Discomfort 1 1
Embolism/Embolus 1 1
No Information 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1
Death 1 1
Embolism 1 1
Extravasation 1 1
Fever 1 1
Hematoma 1 1
Air Embolism 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Paralysis 1 1
Paresis 1 1
Tachycardia 1 1
Transient Ischemic Attack 1 1
Low Blood Pressure/ Hypotension 1 1
Ischemia 1 1
Myocardial Infarction 1 1

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