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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeLOX
Regulation Number 870.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN INTERVENTIONAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
NATEC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 2061 2061
2016 2575 2575
2017 2752 2752
2018 2225 2225
2019 2102 2102
2020 1626 1626

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 6031 6031
Balloon 2981 2981
Difficult to Remove 1651 1651
Break 1385 1385
Failure to Advance 906 906
Shaft 880 880
Improper or Incorrect Procedure or Method 835 835
Detachment Of Device Component 826 826
Deflation Problem 824 824
Inflation Problem 789 789
Catheter 678 678
Adverse Event Without Identified Device or Use Problem 424 424
Material Separation 418 418
Leak/Splash 405 405
Physical Resistance 385 385
Burst Container or Vessel 368 368
Difficult to Advance 338 338
Kinked 279 279
Detachment of Device or Device Component 204 204
Entrapment of Device 200 200
Difficult To Position 187 187
Material Deformation 162 162
Nonstandard Device 103 103
Stretched 92 92
Device Damaged Prior to Use 91 91
Fracture 86 86
Deformation Due to Compressive Stress 85 85
Torn Material 60 60
Folded 54 54
Hole In Material 54 54
Tip 49 49
Material Split, Cut or Torn 44 44
Device Markings/Labelling Problem 40 40
Difficult to Insert 38 38
Device Contamination with Chemical or Other Material 37 37
Physical Property Issue 37 37
Material Integrity Problem 36 36
Difficult to Open or Remove Packaging Material 35 35
Failure to Fold 33 33
Off-Label Use 31 31
Material Puncture/Hole 28 28
Unsealed Device Packaging 28 28
Defective Device 26 26
Component Missing 24 24
Physical Resistance/Sticking 24 24
Device Damaged by Another Device 22 22
Device Operates Differently Than Expected 21 21
Use of Device Problem 16 16
Material Perforation 16 16
Device Dislodged or Dislocated 14 14
Product Quality Problem 14 14
Loose or Intermittent Connection 13 13
Protector 13 13
Device Expiration Issue 13 13
Bent 13 13
Insufficient Information 12 12
Unintended System Motion 12 12
Peeled/Delaminated 12 12
Positioning Problem 12 12
Tear, Rip or Hole in Device Packaging 11 11
Sticking 11 11
Device Handling Problem 11 11
Material Fragmentation 10 10
Activation, Positioning or SeparationProblem 10 10
Device Issue 10 10
Fluid Leak 9 9
Collapse 8 8
Crack 8 8
Contamination 8 8
Device Misassembled During Manufacturing /Shipping 8 8
Partial Blockage 7 7
Device Difficult to Setup or Prepare 7 7
Retraction Problem 7 7
Packaging Problem 7 7
Material Twisted/Bent 6 6
Stent 6 6
Difficult or Delayed Positioning 6 6
Label 6 6
Contamination /Decontamination Problem 6 6
Material Distortion 5 5
Hub 5 5
Migration or Expulsion of Device 5 5
Mechanical Problem 5 5
Device Slipped 5 5
Device Operational Issue 4 4
Component or Accessory Incompatibility 4 4
Incorrect Measurement 4 4
Guidewire 4 4
Device-Device Incompatibility 3 3
Inadequacy of Device Shape and/or Size 3 3
Defective Component 3 3
Device Contaminated During Manufacture or Shipping 3 3
Air Leak 3 3
Positioning Failure 3 3
Patient-Device Incompatibility 3 3
Mechanical Jam 3 3
Device Packaging Compromised 3 3
Noise, Audible 3 3
Material Too Soft/Flexible 3 3
Separation Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10905 10905
No Patient Involvement 1045 1045
No Known Impact Or Consequence To Patient 475 475
Intimal Dissection 173 173
Death 128 128
Device Embedded In Tissue or Plaque 113 113
Vascular Dissection 75 75
Occlusion 70 70
Patient Problem/Medical Problem 64 64
Foreign Body In Patient 56 56
Low Blood Pressure/ Hypotension 52 52
Perforation of Vessels 50 50
Cardiac Arrest 48 48
Myocardial Infarction 43 43
Injury 42 42
Chest Pain 40 40
Perforation 40 40
No Information 35 35
No Code Available 35 35
Angina 31 31
Obstruction/Occlusion 29 29
Bradycardia 28 28
Vessel Or Plaque, Device Embedded In 27 27
Air Embolism 26 26
Non specific EKG/ECG Changes 24 24
Stenosis 21 21
Ischemia 19 19
Thrombosis 18 18
Cardiogenic Shock 16 16
Cardiac Tamponade 15 15
Thrombus 14 14
ST Segment Elevation 14 14
Hematoma 13 13
Calcium Deposits/Calcification 12 12
Embolism 12 12
Stroke/CVA 11 11
Ventricular Fibrillation 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Vasoconstriction 10 10
Arrhythmia 9 9
Pain 8 8
Respiratory Failure 8 8
Pericardial Effusion 7 7
Cardiac Enzyme Elevation 7 7
Blood Loss 6 6
Shock 5 5
Rupture 5 5
High Blood Pressure/ Hypertension 5 5
Cardiopulmonary Arrest 4 4
Ventricular Tachycardia 4 4
Dyspnea 3 3
Atrial Tachycardia 3 3
Respiratory Distress 3 3
Heart Failure 3 3
Hemorrhage/Bleeding 3 3
Unspecified Infection 3 3
Tissue Damage 2 2
Seizures 2 2
Nausea 2 2
Not Applicable 2 2
Aneurysm 2 2
Transient Ischemic Attack 2 2
Renal Failure 2 2
Aortic Dissection 2 2
Discharge 2 2
Multiple Organ Failure 2 2
Insufficient Information 1 1
Ischemic Heart Disease 1 1
Low Cardiac Output 1 1
Cognitive Changes 1 1
Extubate 1 1
Coma 1 1
Prolapse 1 1
Anemia 1 1
Pulmonary Embolism 1 1
Infiltration into Tissue 1 1
Irritation 1 1
Hypersensitivity/Allergic reaction 1 1
Fever 1 1
Gastritis 1 1
Test Result 1 1
Valvular Stenosis 1 1
Discomfort 1 1
Intraoperative Pain 1 1
Reocclusion 1 1
Pneumonia 1 1
Pulmonary Edema 1 1
Tachycardia 1 1
Brain Injury 1 1
Chest Tightness/Pressure 1 1
ST Segment Depression 1 1
Cardiac Perforation 1 1
Loss Of Pulse 1 1
Vascular System (Circulation), Impaired 1 1
Fistula 1 1
Electro-Mechanical Dissociation 1 1
Atherosclerosis 1 1
Atrial Fibrillation 1 1
Exposure to Body Fluids 1 1
Syncope 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Feb-14-2020
2 Abbott Vascular I May-12-2017
3 Boston Scientific Corporation II Nov-26-2019
4 Medtronic Vascular Galway DBA Medtronic Ireland II Oct-11-2019
5 Medtronic Vascular Galway DBA Medtronic Ireland II Sep-20-2017
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