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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
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
1
1. K211807
Sapphire NC 24
ORBUSNEICH MEDICAL TRADING INC.
SUBSTANTIALLY EQUIVALENT
2
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
2019
2102
2102
2020
1974
1974
2021
1738
1738
2022
1816
1816
2023
1723
1723
2024
444
444
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
5142
5142
Difficult to Remove
1113
1113
Break
1076
1076
Difficult to Advance
747
747
Material Separation
685
685
Failure to Advance
604
604
Deflation Problem
535
535
Improper or Incorrect Procedure or Method
503
503
Adverse Event Without Identified Device or Use Problem
409
409
Inflation Problem
337
337
Burst Container or Vessel
306
306
Leak/Splash
286
286
Detachment of Device or Device Component
277
277
Material Deformation
270
270
Entrapment of Device
206
206
Deformation Due to Compressive Stress
132
132
Material Split, Cut or Torn
98
98
Fracture
97
97
Failure to Deflate
94
94
Off-Label Use
80
80
Material Integrity Problem
80
80
Device Markings/Labelling Problem
74
74
Failure to Fold
61
61
Stretched
41
41
Material Puncture/Hole
36
36
Defective Device
32
32
Physical Resistance/Sticking
31
31
Contamination
25
25
Use of Device Problem
23
23
Device-Device Incompatibility
20
20
Device Dislodged or Dislocated
18
18
Difficult to Insert
18
18
Unintended System Motion
16
16
Unsealed Device Packaging
16
16
Device Contamination with Chemical or Other Material
16
16
Difficult to Open or Remove Packaging Material
15
15
Packaging Problem
15
15
Product Quality Problem
15
15
Tear, Rip or Hole in Device Packaging
11
11
Loose or Intermittent Connection
9
9
Material Fragmentation
8
8
Difficult or Delayed Positioning
8
8
Patient-Device Incompatibility
8
8
Material Twisted/Bent
8
8
Insufficient Information
7
7
Component Missing
7
7
Device Damaged by Another Device
7
7
Device Contaminated During Manufacture or Shipping
6
6
Fluid/Blood Leak
6
6
Material Perforation
5
5
Positioning Problem
5
5
Contamination /Decontamination Problem
5
5
Patient Device Interaction Problem
4
4
Peeled/Delaminated
4
4
Device Difficult to Setup or Prepare
3
3
Defective Component
3
3
Mechanical Jam
3
3
Activation, Positioning or Separation Problem
3
3
Obstruction of Flow
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Material Too Soft/Flexible
3
3
Wrong Label
2
2
Separation Problem
2
2
Gas/Air Leak
2
2
No Flow
2
2
No Apparent Adverse Event
2
2
Noise, Audible
2
2
Retraction Problem
2
2
Material Too Rigid or Stiff
2
2
Mechanical Problem
2
2
Migration or Expulsion of Device
1
1
Flaked
1
1
Device Damaged Prior to Use
1
1
Unexpected Therapeutic Results
1
1
Unraveled Material
1
1
Inadequacy of Device Shape and/or Size
1
1
Component Misassembled
1
1
Explosion
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Pressure Problem
1
1
Misassembly by Users
1
1
Connection Problem
1
1
Illegible Information
1
1
Air/Gas in Device
1
1
Poor Visibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5098
5098
No Consequences Or Impact To Patient
3453
3453
No Patient Involvement
235
235
Insufficient Information
225
225
No Known Impact Or Consequence To Patient
163
163
Vascular Dissection
160
160
Myocardial Infarction
113
113
Device Embedded In Tissue or Plaque
105
105
Foreign Body In Patient
100
100
Obstruction/Occlusion
85
85
Low Blood Pressure/ Hypotension
68
68
Perforation of Vessels
66
66
Perforation
49
49
Cardiac Arrest
46
46
Arrhythmia
44
44
Angina
39
39
Injury
39
39
Air Embolism
38
38
Ischemia
37
37
Hematoma
33
33
Occlusion
30
30
Non specific EKG/ECG Changes
29
29
Chest Pain
29
29
Death
28
28
Embolism/Embolus
28
28
Thrombosis/Thrombus
24
24
Bradycardia
24
24
No Code Available
23
23
Hemorrhage/Bleeding
22
22
Intimal Dissection
21
21
High Blood Pressure/ Hypertension
19
19
Unspecified Tissue Injury
19
19
Cardiogenic Shock
17
17
Stenosis
17
17
Vessel Or Plaque, Device Embedded In
16
16
Ventricular Fibrillation
14
14
Pain
14
14
Pericardial Effusion
14
14
Tachycardia
12
12
Vasoconstriction
11
11
Unspecified Heart Problem
10
10
Atrial Fibrillation
9
9
Stroke/CVA
9
9
Unspecified Infection
9
9
Embolism
9
9
Cardiac Tamponade
7
7
Pulmonary Edema
7
7
Heart Failure/Congestive Heart Failure
7
7
Restenosis
6
6
Thrombosis
6
6
Thrombus
6
6
Dyspnea
6
6
Hypoxia
5
5
Shock
5
5
Patient Problem/Medical Problem
5
5
No Information
5
5
Cardiac Enzyme Elevation
4
4
Calcium Deposits/Calcification
4
4
Aneurysm
4
4
Extravasation
3
3
Fatigue
3
3
Fistula
3
3
Hypersensitivity/Allergic reaction
3
3
Renal Failure
3
3
Multiple Organ Failure
3
3
Respiratory Failure
3
3
Blood Loss
3
3
Pseudoaneurysm
2
2
Cardiac Perforation
2
2
Chest Tightness/Pressure
2
2
Unintended Radiation Exposure
2
2
Syncope/Fainting
2
2
Arteriosclerosis/ Atherosclerosis
2
2
Heart Block
2
2
ST Segment Elevation
2
2
Seizures
2
2
Anxiety
2
2
Discomfort
2
2
Rupture
2
2
Ventricular Tachycardia
2
2
Failure of Implant
2
2
Fever
2
2
Intracranial Hemorrhage
1
1
Hemoptysis
1
1
Laceration(s)
1
1
Syncope
1
1
Anaphylactic Shock
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Great Vessel Perforation
1
1
Heart Failure
1
1
Post Operative Wound Infection
1
1
Tissue Damage
1
1
Transient Ischemic Attack
1
1
Local Reaction
1
1
Pneumonia
1
1
Reocclusion
1
1
Nausea
1
1
Foreign Body Embolism
1
1
Convulsion/Seizure
1
1
Mitral Valve Insufficiency/ Regurgitation
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
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