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TPLC
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show TPLC since
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2020
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2025
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Device
device, angioplasty, laser, coronary
Product Code
LPC
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
1
2
4
4
2
0
MDR Year
MDR Reports
MDR Events
2020
7
7
2021
7
129
2022
15
15
2023
23
23
2024
12
12
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
20
20
Power Problem
12
12
Detachment of Device or Device Component
8
8
Material Separation
8
8
Sharp Edges
4
4
Break
4
4
Failure to Calibrate
3
3
Material Integrity Problem
2
2
Material Frayed
1
1
Failure to Deliver Energy
1
123
Material Puncture/Hole
1
1
Material Deformation
1
1
Device Displays Incorrect Message
1
1
Material Twisted/Bent
1
1
Calibration Problem
1
1
Energy Output Problem
1
1
Failure to Recalibrate
1
1
Failure to Align
1
1
Material Split, Cut or Torn
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
30
152
Perforation of Vessels
18
18
Thrombosis/Thrombus
14
14
Unintended Radiation Exposure
8
8
Iatrogenic Source
4
4
Radiation Exposure, Unintended
3
3
Insufficient Information
2
2
Cardiac Perforation
2
2
No Known Impact Or Consequence To Patient
2
2
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Spectranetics Corporation
II
Nov-11-2022
2
Spectranetics Corporation
II
Jul-11-2022
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