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 percutaneous catheter, ultrasound
Regulation Description Percutaneous catheter.
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
BOLT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHOCKWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2021 18 18
2022 35 35
2023 30 30
2024 45 45
2025 44 44
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 97 97
Difficult to Remove 59 59
Material Split, Cut or Torn 41 41
Adverse Event Without Identified Device or Use Problem 36 36
Material Separation 31 31
Material Rupture 20 20
Off-Label Use 16 16
Entrapment of Device 8 8
Difficult to Advance 5 5
Deflation Problem 4 4
Break 3 3
Material Puncture/Hole 3 3
Defective Device 3 3
Material Fragmentation 3 3
Failure to Deflate 3 3
Improper or Incorrect Procedure or Method 3 3
Device-Device Incompatibility 2 2
Stretched 2 2
Inflation Problem 2 2
Material Deformation 2 2
Retraction Problem 2 2
Leak/Splash 1 1
Activation, Positioning or Separation Problem 1 1
Burst Container or Vessel 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Positioning Problem 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Device Damaged by Another Device 1 1
Infusion or Flow Problem 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Nonstandard Device 1 1
Display or Visual Feedback Problem 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 112 112
Foreign Body In Patient 19 19
Insufficient Information 10 10
Vascular Dissection 9 9
Perforation of Vessels 8 8
Perforation 7 7
Hemorrhage/Bleeding 7 7
Embolism/Embolus 5 5
Hematoma 4 4
Obstruction/Occlusion 4 4
Cardiac Arrest 4 4
Device Embedded In Tissue or Plaque 3 3
Restenosis 3 3
Low Blood Pressure/ Hypotension 3 3
Retroperitoneal Hemorrhage 3 3
Foreign Body Embolism 2 2
Pain 2 2
Hemorrhagic Stroke 2 2
Tachycardia 2 2
Renal Failure 2 2
Myocardial Infarction 2 2
Ischemia 2 2
Transient Ischemic Attack 1 1
Cardiac Tamponade 1 1
Post Operative Wound Infection 1 1
Fever 1 1
Paralysis 1 1
Rupture 1 1
Thrombosis/Thrombus 1 1
Atrial Fibrillation 1 1
Discomfort 1 1
Viral Infection 1 1
Cardiogenic Shock 1 1
Paresis 1 1
Bradycardia 1 1
Swelling/ Edema 1 1
Extravasation 1 1
Shock 1 1
Pseudoaneurysm 1 1
Thromboembolism 1 1
Mitral Perforation 1 1
Spinal Cord Injury 1 1
Low Oxygen Saturation 1 1
Arrhythmia 1 1
Air Embolism 1 1

-
-