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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device device, angioplasty, laser, coronary
Product CodeLPC
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 4 10 11 5 7 7 7 10 8 2 1 2 4 4 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 15 15
2016 12 12
2017 21 21
2018 16 16
2019 19 19
2020 7 7
2021 7 129
2022 15 15
2023 23 23
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 42 42
Insufficient Information 25 25
Detachment of Device or Device Component 15 15
Power Problem 11 11
Material Separation 7 7
Break 7 7
Material Deformation 6 6
Material Split, Cut or Torn 5 5
Device Dislodged or Dislocated 4 4
Failure to Calibrate 4 4
Device Operates Differently Than Expected 4 4
Device Displays Incorrect Message 4 4
Detachment Of Device Component 3 3
Difficult to Advance 3 3
Difficult to Remove 3 3
Material Protrusion/Extrusion 2 2
Material Integrity Problem 2 2
Calibration Problem 2 2
Occlusion Within Device 2 2
Incorrect Or Inadequate Test Results 2 2
Leak/Splash 2 2
Material Frayed 2 2
Solder Joint Fracture 1 1
Use of Device Problem 1 1
Inflation Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Recalibrate 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Obstruction of Flow 1 1
Positioning Problem 1 1
Material Twisted/Bent 1 1
Failure to Advance 1 1
Fracture 1 1
Material Puncture/Hole 1 1
Energy Output Problem 1 1
Failure to Cycle 1 1
Device Inoperable 1 1
Mechanical Problem 1 1
Unintended Movement 1 1
Output Problem 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Physical Resistance 1 1
Crack 1 1
Thermal Decomposition of Device 1 1
Material Perforation 1 1
Sticking 1 1
Pressure Problem 1 1
Failure to Deliver Energy 1 123

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 37 37
Perforation of Vessels 28 28
No Clinical Signs, Symptoms or Conditions 23 145
Iatrogenic Source 18 18
No Known Impact Or Consequence To Patient 15 15
Thrombosis/Thrombus 14 14
Radiation Exposure, Unintended 9 9
Death 8 8
No Consequences Or Impact To Patient 8 8
Vascular Dissection 7 7
Device Embedded In Tissue or Plaque 7 7
Unintended Radiation Exposure 7 7
Cardiac Perforation 6 6
Hemorrhage/Bleeding 6 6
Low Blood Pressure/ Hypotension 4 4
Cardiac Tamponade 3 3
Injury 3 3
Stenosis 3 3
Intimal Dissection 3 3
No Code Available 2 2
Obstruction/Occlusion 2 2
Insufficient Information 2 2
Occlusion 1 1
No Information 1 1
Cardiac Arrest 1 1
Angina 1 1
Visual Disturbances 1 1
Foreign Body In Patient 1 1
Chest Pain 1 1
Hemostasis 1 1
Pain 1 1
Extravasation 1 1
Shock 1 1
Aneurysm 1 1
Embolism 1 1
Pseudoaneurysm 1 1
Atrial Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corp. II Apr-11-2012
2 Spectranetics Corporation II Nov-11-2022
3 Spectranetics Corporation II Jul-11-2022
4 Spectranetics Corporation II Nov-28-2016
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