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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
device, angioplasty, laser, coronary
Product Code
LPC
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
0
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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
41
41
Insufficient Information
25
25
Detachment of Device or Device Component
15
15
Power Problem
10
10
Break
7
7
Material Separation
6
6
Material Deformation
6
6
Material Split, Cut or Torn
5
5
Device Dislodged or Dislocated
4
4
Device Operates Differently Than Expected
4
4
Device Displays Incorrect Message
4
4
Failure to Calibrate
4
4
Difficult to Advance
3
3
Difficult to Remove
3
3
Detachment Of Device Component
3
3
Material Frayed
2
2
Calibration Problem
2
2
Leak/Splash
2
2
Incorrect Or Inadequate Test Results
2
2
Occlusion Within Device
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
2
2
Material Twisted/Bent
1
1
Device Contamination with Chemical or Other Material
1
1
Output Problem
1
1
Positioning Problem
1
1
Pressure Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Energy Output Problem
1
1
Material Puncture/Hole
1
1
Failure to Recalibrate
1
1
Failure to Advance
1
1
Physical Resistance
1
1
Defective Device
1
1
Mechanical Problem
1
1
Failure to Fire
1
1
Inflation Problem
1
1
Difficult to Insert
1
1
Thermal Decomposition of Device
1
1
Component Falling
1
1
Crack
1
1
Failure to Cycle
1
1
Failure to Deliver Energy
1
123
Fracture
1
1
Material Fragmentation
1
1
Sticking
1
1
Device Inoperable
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Material Perforation
1
1
Solder Joint Fracture
1
1
Obstruction of Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation
37
37
Perforation of Vessels
27
27
No Clinical Signs, Symptoms or Conditions
21
143
Iatrogenic Source
18
18
No Known Impact Or Consequence To Patient
15
15
Thrombosis/Thrombus
14
14
Radiation Exposure, Unintended
9
9
No Consequences Or Impact To Patient
8
8
Death
8
8
Device Embedded In Tissue or Plaque
7
7
Vascular Dissection
7
7
Cardiac Perforation
6
6
Unintended Radiation Exposure
6
6
Hemorrhage/Bleeding
6
6
Low Blood Pressure/ Hypotension
4
4
Cardiac Tamponade
3
3
Stenosis
3
3
Injury
3
3
Intimal Dissection
3
3
Obstruction/Occlusion
2
2
Insufficient Information
2
2
No Code Available
2
2
No Information
1
1
Pseudoaneurysm
1
1
Foreign Body In Patient
1
1
Atrial Perforation
1
1
Visual Disturbances
1
1
Occlusion
1
1
Pain
1
1
Shock
1
1
Aneurysm
1
1
Angina
1
1
Cardiac Arrest
1
1
Chest Pain
1
1
Hemostasis
1
1
Embolism
1
1
Extravasation
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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