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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
1721
1721
2024
1808
1808
2025
1103
1103
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
5500
5500
Difficult to Remove
1149
1149
Difficult to Advance
905
905
Break
885
885
Adverse Event Without Identified Device or Use Problem
802
802
Material Separation
573
573
Failure to Advance
553
553
Deflation Problem
538
538
Improper or Incorrect Procedure or Method
481
481
Inflation Problem
337
337
Burst Container or Vessel
322
322
Detachment of Device or Device Component
313
313
Material Deformation
309
309
Leak/Splash
269
269
Entrapment of Device
229
229
Failure to Deflate
152
152
Material Split, Cut or Torn
116
116
Deformation Due to Compressive Stress
109
109
Material Integrity Problem
100
100
Fracture
93
93
Off-Label Use
72
72
Device Markings/Labelling Problem
64
64
Failure to Fold
61
61
Defective Device
34
34
Stretched
31
31
Physical Resistance/Sticking
29
29
Material Puncture/Hole
28
28
Use of Device Problem
28
28
Contamination
24
24
Device Dislodged or Dislocated
21
21
Device-Device Incompatibility
21
21
Difficult to Open or Remove Packaging Material
19
19
Difficult to Insert
18
18
Device Contamination with Chemical or Other Material
17
17
Device Damaged by Another Device
15
15
Component Missing
14
14
Product Quality Problem
13
13
Packaging Problem
13
13
Unintended System Motion
12
12
Unsealed Device Packaging
11
11
Tear, Rip or Hole in Device Packaging
10
10
Positioning Problem
10
10
Insufficient Information
8
8
Obstruction of Flow
8
8
Difficult or Delayed Positioning
7
7
Material Fragmentation
7
7
Patient-Device Incompatibility
7
7
Material Twisted/Bent
6
6
Device Misassembled During Manufacturing /Shipping
5
5
Contamination /Decontamination Problem
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6971
6971
No Consequences Or Impact To Patient
1720
1720
Insufficient Information
311
311
Vascular Dissection
220
220
Myocardial Infarction
179
179
Foreign Body In Patient
140
140
Cardiac Arrest
130
130
Cardiogenic Shock
115
115
Obstruction/Occlusion
112
112
Device Embedded In Tissue or Plaque
111
111
Perforation of Vessels
107
107
Hemorrhage/Bleeding
92
92
No Patient Involvement
91
91
Heart Failure/Congestive Heart Failure
90
90
Low Blood Pressure/ Hypotension
81
81
No Known Impact Or Consequence To Patient
74
74
Perforation
62
62
Hematoma
57
57
Arrhythmia
52
52
Chest Pain
45
45
Unspecified Kidney or Urinary Problem
45
45
Embolism/Embolus
44
44
Angina
42
42
Ischemia
41
41
Air Embolism
37
37
Non specific EKG/ECG Changes
37
37
Thrombosis/Thrombus
35
35
Bradycardia
24
24
Death
23
23
Unspecified Heart Problem
20
20
Injury
20
20
Unspecified Tissue Injury
19
19
Pericardial Effusion
16
16
Pain
16
16
Ventricular Fibrillation
15
15
Cardiac Tamponade
15
15
No Code Available
15
15
High Blood Pressure/ Hypertension
14
14
Stenosis
13
13
Tachycardia
13
13
Vasoconstriction
11
11
Atrial Fibrillation
9
9
Restenosis
9
9
Occlusion
7
7
Pulmonary Edema
7
7
Unspecified Infection
7
7
Dyspnea
6
6
Shock
6
6
Extravasation
6
6
Retroperitoneal Hemorrhage
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
I
Feb-14-2020
2
Medtronic Inc
II
Aug-01-2022
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