Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
catheters, transluminal coronary angioplasty, percutaneous
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
2
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
BROSMED MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
DONGGUAN TT MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
KANEKA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
MEDCAPTAIN LIFE SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MEDINOL, LTD.
SUBSTANTIALLY EQUIVALENT
1
MERIL LIFE SCIENCES PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
NATEC MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ORBUSNEICH MEDICAL TRADING INC.
SUBSTANTIALLY EQUIVALENT
4
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SINO MEDICAL SCIENCES TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
2
SIS MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
2225
2225
2019
2102
2102
2020
1974
1974
2021
1738
1738
2022
1816
1816
2023
1141
1141
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
5500
5500
Break
1229
1229
Difficult to Remove
1199
1199
Failure to Advance
789
789
Difficult to Advance
734
734
Material Separation
711
711
Deflation Problem
610
610
Improper or Incorrect Procedure or Method
565
565
Adverse Event Without Identified Device or Use Problem
459
459
Inflation Problem
378
378
Burst Container or Vessel
372
372
Detachment of Device or Device Component
302
302
Leak/Splash
297
297
Material Deformation
274
274
Entrapment of Device
214
214
Deformation Due to Compressive Stress
139
139
Detachment Of Device Component
137
137
Fracture
98
98
Material Split, Cut or Torn
89
89
Device Markings/Labelling Problem
81
81
Material Integrity Problem
73
73
Failure to Fold
67
67
Off-Label Use
67
67
Failure to Deflate
64
64
Stretched
49
49
Physical Resistance
49
49
Material Puncture/Hole
42
42
Physical Resistance/Sticking
39
39
Kinked
38
38
Defective Device
32
32
Use of Device Problem
26
26
Difficult To Position
25
25
Contamination
25
25
Unsealed Device Packaging
24
24
Device Dislodged or Dislocated
23
23
Device Contamination with Chemical or Other Material
19
19
Device-Device Incompatibility
19
19
Device Damaged Prior to Use
19
19
Unintended System Motion
17
17
Product Quality Problem
17
17
Difficult to Insert
17
17
Packaging Problem
16
16
Difficult to Open or Remove Packaging Material
14
14
Folded
12
12
Material Fragmentation
11
11
Physical Property Issue
11
11
Positioning Problem
11
11
Insufficient Information
10
10
Device Damaged by Another Device
10
10
Tear, Rip or Hole in Device Packaging
9
9
Component Missing
9
9
Difficult or Delayed Positioning
9
9
Loose or Intermittent Connection
9
9
Device Issue
8
8
Sticking
8
8
Patient-Device Incompatibility
8
8
Hole In Material
7
7
Fluid/Blood Leak
7
7
Material Twisted/Bent
7
7
Contamination /Decontamination Problem
6
6
Material Perforation
6
6
Defective Component
6
6
Peeled/Delaminated
5
5
Device Contaminated During Manufacture or Shipping
5
5
Torn Material
5
5
Nonstandard Device
4
4
Mechanical Problem
4
4
Device Operates Differently Than Expected
4
4
Device Operational Issue
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Activation, Positioning or Separation Problem
3
3
Retraction Problem
3
3
Material Too Rigid or Stiff
3
3
Bent
3
3
Mechanical Jam
3
3
Separation Problem
3
3
Patient Device Interaction Problem
3
3
Material Too Soft/Flexible
3
3
Wrong Label
2
2
Component Misassembled
2
2
No Flow
2
2
Noise, Audible
2
2
Gas/Air Leak
2
2
Human Factors Issue
2
2
Device Difficult to Setup or Prepare
2
2
Migration or Expulsion of Device
2
2
Incorrect Measurement
2
2
Obstruction of Flow
2
2
Device Slipped
2
2
Unexpected Therapeutic Results
1
1
Unraveled Material
1
1
Device Or Device Fragments Location Unknown
1
1
Connection Problem
1
1
Delamination
1
1
Decrease in Pressure
1
1
Inadequacy of Device Shape and/or Size
1
1
Air Leak
1
1
Filling Problem
1
1
Flaked
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
5257
5257
No Clinical Signs, Symptoms or Conditions
4193
4193
No Patient Involvement
380
380
No Known Impact Or Consequence To Patient
272
272
Insufficient Information
189
189
Vascular Dissection
161
161
Device Embedded In Tissue or Plaque
114
114
Myocardial Infarction
109
109
Foreign Body In Patient
94
94
Obstruction/Occlusion
69
69
Death
67
67
Low Blood Pressure/ Hypotension
62
62
Perforation of Vessels
59
59
Perforation
54
54
Cardiac Arrest
44
44
Intimal Dissection
43
43
Angina
42
42
Occlusion
40
40
Injury
40
40
Ischemia
39
39
Air Embolism
37
37
Arrhythmia
35
35
Chest Pain
31
31
Hematoma
30
30
Bradycardia
28
28
Non specific EKG/ECG Changes
27
27
Patient Problem/Medical Problem
27
27
No Code Available
27
27
Stenosis
21
21
Embolism/Embolus
20
20
Thrombosis/Thrombus
20
20
Unspecified Tissue Injury
19
19
Hemorrhage/Bleeding
18
18
Vessel Or Plaque, Device Embedded In
17
17
Cardiogenic Shock
17
17
High Blood Pressure/ Hypertension
16
16
Vasoconstriction
15
15
Ventricular Fibrillation
15
15
Pericardial Effusion
14
14
Thrombosis
13
13
Pain
12
12
No Information
12
12
Tachycardia
11
11
Embolism
11
11
Cardiac Tamponade
10
10
Thrombus
7
7
ST Segment Elevation
7
7
Pulmonary Edema
7
7
Atrial Fibrillation
7
7
Stroke/CVA
7
7
Calcium Deposits/Calcification
6
6
Unspecified Infection
6
6
Respiratory Failure
6
6
Restenosis
5
5
Dyspnea
5
5
Cardiac Enzyme Elevation
4
4
Shock
4
4
Blood Loss
4
4
Heart Failure/Congestive Heart Failure
4
4
Multiple Organ Failure
3
3
Ventricular Tachycardia
3
3
Rupture
3
3
Extravasation
3
3
Fistula
3
3
Aneurysm
3
3
Fatigue
2
2
Fever
2
2
Hypersensitivity/Allergic reaction
2
2
Heart Failure
2
2
Anxiety
2
2
Discomfort
2
2
Failure of Implant
2
2
Seizures
2
2
Renal Failure
2
2
Syncope/Fainting
2
2
Arteriosclerosis/ Atherosclerosis
2
2
Heart Block
2
2
Unspecified Heart Problem
2
2
Pseudoaneurysm
2
2
Cardiac Perforation
2
2
Chest Tightness/Pressure
2
2
Unintended Radiation Exposure
2
2
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Prolapse
1
1
Post Operative Wound Infection
1
1
Loss Of Pulse
1
1
Vascular System (Circulation), Impaired
1
1
Low Cardiac Output
1
1
Diminished Pulse Pressure
1
1
Test Result
1
1
Respiratory Insufficiency
1
1
Liver Failure
1
1
Renal Impairment
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Mitral Valve Insufficiency/ Regurgitation
1
1
Foreign Body Embolism
1
1
Convulsion/Seizure
1
1
Local Reaction
1
1
Pneumonia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
I
Feb-14-2020
2
Boston Scientific Corporation
II
Nov-26-2019
3
Medtronic Inc
II
Aug-01-2022
4
Medtronic Vascular Galway DBA Medtronic Ireland
II
Oct-11-2019
-
-