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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
2
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
BROSMED MEDICAL CO., LTD.
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
SINO MEDICAL SCIENCES TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
1
SIS MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
2225
2225
2019
2102
2102
2020
1974
1974
2021
1741
1741
2022
1817
1817
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
4826
4826
Break
1161
1161
Difficult to Remove
1046
1046
Failure to Advance
708
708
Difficult to Advance
632
632
Material Separation
631
631
Deflation Problem
565
565
Improper or Incorrect Procedure or Method
478
478
Adverse Event Without Identified Device or Use Problem
404
404
Inflation Problem
348
348
Burst Container or Vessel
321
321
Leak/Splash
267
267
Detachment of Device or Device Component
261
261
Material Deformation
247
247
Entrapment of Device
185
185
Detachment Of Device Component
137
137
Deformation Due to Compressive Stress
123
123
Fracture
91
91
Device Markings/Labelling Problem
80
80
Material Split, Cut or Torn
79
79
Material Integrity Problem
66
66
Failure to Fold
64
64
Off-Label Use
58
58
Physical Resistance
49
49
Stretched
45
45
Failure to Deflate
45
45
Material Puncture/Hole
41
41
Kinked
38
38
Physical Resistance/Sticking
37
37
Defective Device
26
26
Difficult To Position
25
25
Unsealed Device Packaging
24
24
Use of Device Problem
23
23
Device Damaged Prior to Use
19
19
Contamination
19
19
Device Dislodged or Dislocated
19
19
Difficult to Insert
17
17
Unintended System Motion
17
17
Product Quality Problem
16
16
Device-Device Incompatibility
15
15
Device Contamination with Chemical or Other Material
13
13
Difficult to Open or Remove Packaging Material
12
12
Folded
12
12
Physical Property Issue
11
11
Positioning Problem
11
11
Packaging Problem
10
10
Material Fragmentation
10
10
Difficult or Delayed Positioning
9
9
Loose or Intermittent Connection
9
9
Device Damaged by Another Device
9
9
Component Missing
9
9
Tear, Rip or Hole in Device Packaging
9
9
Insufficient Information
9
9
Device Issue
8
8
Sticking
8
8
Patient-Device Incompatibility
7
7
Hole In Material
7
7
Fluid/Blood Leak
7
7
Defective Component
6
6
Material Perforation
6
6
Material Twisted/Bent
6
6
Device Contaminated During Manufacture or Shipping
5
5
Torn Material
5
5
Contamination /Decontamination Problem
5
5
Peeled/Delaminated
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
Material Too Soft/Flexible
3
3
Noise, Audible
2
2
Gas/Air Leak
2
2
Human Factors Issue
2
2
No Flow
2
2
Device Slipped
2
2
Migration or Expulsion of Device
2
2
Incorrect Measurement
2
2
Obstruction of Flow
2
2
Device Or Device Fragments Location Unknown
1
1
Unexpected Therapeutic Results
1
1
Unraveled Material
1
1
Connection Problem
1
1
Delamination
1
1
Device Difficult to Setup or Prepare
1
1
Decrease in Pressure
1
1
Air Leak
1
1
Filling Problem
1
1
Flaked
1
1
Misassembly by Users
1
1
No Apparent Adverse Event
1
1
Pressure Problem
1
1
Human-Device Interface Problem
1
1
Incorrect Device Or Component Shipped
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
3174
3174
No Patient Involvement
380
380
No Known Impact Or Consequence To Patient
272
272
Insufficient Information
152
152
Vascular Dissection
139
139
Device Embedded In Tissue or Plaque
100
100
Myocardial Infarction
89
89
Foreign Body In Patient
82
82
Death
67
67
Obstruction/Occlusion
60
60
Low Blood Pressure/ Hypotension
53
53
Perforation
51
51
Perforation of Vessels
50
50
Intimal Dissection
43
43
Occlusion
40
40
Injury
40
40
Cardiac Arrest
39
39
Arrhythmia
34
34
Ischemia
34
34
Air Embolism
33
33
Angina
32
32
Bradycardia
27
27
Patient Problem/Medical Problem
27
27
No Code Available
27
27
Hematoma
25
25
Non specific EKG/ECG Changes
23
23
Chest Pain
23
23
Unspecified Tissue Injury
19
19
Vessel Or Plaque, Device Embedded In
17
17
Cardiogenic Shock
17
17
Stenosis
17
17
High Blood Pressure/ Hypertension
16
16
Embolism/Embolus
16
16
Thrombosis/Thrombus
14
14
Thrombosis
13
13
Vasoconstriction
13
13
Ventricular Fibrillation
13
13
Hemorrhage/Bleeding
13
13
Pericardial Effusion
12
12
No Information
12
12
Embolism
11
11
Pain
11
11
Tachycardia
10
10
Cardiac Tamponade
9
9
Thrombus
7
7
Pulmonary Edema
7
7
ST Segment Elevation
7
7
Stroke/CVA
7
7
Calcium Deposits/Calcification
6
6
Unspecified Infection
6
6
Respiratory Failure
6
6
Blood Loss
4
4
Restenosis
4
4
Multiple Organ Failure
3
3
Dyspnea
3
3
Cardiac Enzyme Elevation
3
3
Extravasation
3
3
Fistula
3
3
Atrial Fibrillation
3
3
Aneurysm
3
3
Rupture
3
3
Shock
3
3
Ventricular Tachycardia
3
3
Heart Failure
2
2
Anxiety
2
2
Discomfort
2
2
Seizures
2
2
Renal Failure
2
2
Fatigue
2
2
Hypersensitivity/Allergic reaction
2
2
Cardiac Perforation
2
2
Chest Tightness/Pressure
2
2
Unintended Radiation Exposure
2
2
Unspecified Heart Problem
2
2
Syncope/Fainting
2
2
Convulsion/Seizure
1
1
Heart Block
1
1
Heart Failure/Congestive Heart Failure
1
1
Mitral Valve Insufficiency/ Regurgitation
1
1
Liver Failure
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Foreign Body Embolism
1
1
Swelling/ Edema
1
1
Prolapse
1
1
Low Cardiac Output
1
1
Loss Of Pulse
1
1
Vascular System (Circulation), Impaired
1
1
Pseudoaneurysm
1
1
Diminished Pulse Pressure
1
1
Test Result
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Intracranial Hemorrhage
1
1
Infiltration into Tissue
1
1
Hypoxia
1
1
Failure of Implant
1
1
Fever
1
1
Gastritis
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Atherosclerosis
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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