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Device
catheters, transluminal coronary angioplasty, percutaneous
Regulation Description
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Product Code
LOX
Regulation Number
870.5100
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT VASCULAR
SUBSTANTIALLY EQUIVALENT
1
BIOTRONIK, INC.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
BROSMED MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
DONGGUAN TT MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MEDCAPTAIN LIFE SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
NATEC MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
ORBUSNEICH MEDICAL TRADING INC.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SINO MEDICAL SCIENCES TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
2
SIS MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1974
1974
2021
1738
1738
2022
1816
1816
2023
1723
1723
2024
1807
1807
2025
125
125
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
5146
5146
Difficult to Remove
1067
1067
Break
842
842
Difficult to Advance
815
815
Material Separation
531
531
Failure to Advance
526
526
Deflation Problem
492
492
Improper or Incorrect Procedure or Method
443
443
Adverse Event Without Identified Device or Use Problem
403
403
Inflation Problem
312
312
Burst Container or Vessel
303
303
Detachment of Device or Device Component
286
286
Material Deformation
277
277
Leak/Splash
252
252
Entrapment of Device
216
216
Failure to Deflate
141
141
Material Split, Cut or Torn
107
107
Deformation Due to Compressive Stress
99
99
Fracture
90
90
Material Integrity Problem
87
87
Off-Label Use
71
71
Device Markings/Labelling Problem
64
64
Failure to Fold
57
57
Stretched
31
31
Defective Device
29
29
Material Puncture/Hole
25
25
Use of Device Problem
25
25
Contamination
23
23
Physical Resistance/Sticking
23
23
Device-Device Incompatibility
21
21
Device Dislodged or Dislocated
20
20
Difficult to Insert
17
17
Difficult to Open or Remove Packaging Material
17
17
Device Contamination with Chemical or Other Material
14
14
Component Missing
13
13
Product Quality Problem
13
13
Packaging Problem
13
13
Unintended System Motion
12
12
Unsealed Device Packaging
11
11
Positioning Problem
10
10
Tear, Rip or Hole in Device Packaging
10
10
Device Damaged by Another Device
9
9
Insufficient Information
8
8
Patient-Device Incompatibility
8
8
Difficult or Delayed Positioning
7
7
Material Fragmentation
7
7
Obstruction of Flow
7
7
Material Twisted/Bent
6
6
Contamination /Decontamination Problem
5
5
Device Misassembled During Manufacturing /Shipping
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6432
6432
No Consequences Or Impact To Patient
1720
1720
Insufficient Information
288
288
Vascular Dissection
170
170
Foreign Body In Patient
117
117
Myocardial Infarction
114
114
Obstruction/Occlusion
107
107
Device Embedded In Tissue or Plaque
104
104
No Patient Involvement
91
91
Perforation of Vessels
77
77
No Known Impact Or Consequence To Patient
74
74
Low Blood Pressure/ Hypotension
71
71
Arrhythmia
52
52
Cardiac Arrest
44
44
Perforation
44
44
Embolism/Embolus
41
41
Chest Pain
41
41
Angina
40
40
Ischemia
37
37
Air Embolism
35
35
Non specific EKG/ECG Changes
34
34
Thrombosis/Thrombus
32
32
Hematoma
28
28
Hemorrhage/Bleeding
24
24
Death
23
23
Bradycardia
23
23
Injury
20
20
Unspecified Heart Problem
20
20
Cardiogenic Shock
19
19
Unspecified Tissue Injury
19
19
Ventricular Fibrillation
15
15
No Code Available
15
15
High Blood Pressure/ Hypertension
14
14
Pain
14
14
Tachycardia
13
13
Pericardial Effusion
12
12
Vasoconstriction
11
11
Stenosis
10
10
Atrial Fibrillation
9
9
Heart Failure/Congestive Heart Failure
8
8
Occlusion
7
7
Unspecified Infection
7
7
Pulmonary Edema
7
7
Restenosis
7
7
Vessel Or Plaque, Device Embedded In
6
6
Dyspnea
6
6
Shock
6
6
Cardiac Tamponade
5
5
Intimal Dissection
5
5
Stroke/CVA
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
I
Feb-14-2020
2
Medtronic Inc
II
Aug-01-2022
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