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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 CodeLOX
Regulation Number 870.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN INTERVENTIONAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 4
SIS MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2752 2752
2018 2225 2225
2019 2102 2102
2020 1974 1974
2021 1741 1741
2022 1661 1661

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5867 5867
Difficult to Remove 1462 1462
Break 1378 1378
Failure to Advance 903 903
Deflation Problem 761 761
Improper or Incorrect Procedure or Method 658 658
Material Separation 626 626
Difficult to Advance 622 622
Inflation Problem 564 564
Adverse Event Without Identified Device or Use Problem 455 455
Detachment Of Device Component 410 410
Burst Container or Vessel 382 382
Leak/Splash 345 345
Detachment of Device or Device Component 287 287
Material Deformation 253 253
Entrapment of Device 216 216
Physical Resistance 183 183
Kinked 127 127
Deformation Due to Compressive Stress 121 121
Nonstandard Device 103 103
Fracture 97 97
Material Split, Cut or Torn 78 78
Difficult To Position 74 74
Stretched 73 73
Device Markings/Labelling Problem 69 69
Material Integrity Problem 65 65
Failure to Fold 62 62
Device Damaged Prior to Use 52 52
Off-Label Use 51 51
Material Puncture/Hole 42 42
Physical Resistance/Sticking 37 37
Device Contamination with Chemical or Other Material 34 34
Difficult to Open or Remove Packaging Material 34 34
Failure to Deflate 34 34
Defective Device 28 28
Folded 27 27
Hole In Material 26 26
Physical Property Issue 26 26
Difficult to Insert 26 26
Unsealed Device Packaging 25 25
Use of Device Problem 24 24
Torn Material 22 22
Device Dislodged or Dislocated 20 20
Contamination 19 19
Product Quality Problem 19 19
Unintended System Motion 17 17
Positioning Problem 15 15
Component Missing 15 15
Device-Device Incompatibility 15 15
Device Damaged by Another Device 15 15
Material Perforation 12 12
Insufficient Information 11 11
Loose or Intermittent Connection 11 11
Material Fragmentation 11 11
Tear, Rip or Hole in Device Packaging 11 11
Device Issue 10 10
Patient-Device Incompatibility 10 10
Packaging Problem 10 10
Difficult or Delayed Positioning 9 9
Fluid/Blood Leak 8 8
Sticking 8 8
Peeled/Delaminated 7 7
Device Operates Differently Than Expected 7 7
Material Twisted/Bent 7 7
Activation, Positioning or Separation Problem 7 7
Contamination /Decontamination Problem 6 6
Bent 6 6
Defective Component 6 6
Device Misassembled During Manufacturing /Shipping 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Handling Problem 5 5
Mechanical Problem 5 5
Device Expiration Issue 5 5
Crack 4 4
Mechanical Jam 4 4
Device Operational Issue 4 4
Migration or Expulsion of Device 3 3
Material Too Rigid or Stiff 3 3
Retraction Problem 3 3
Collapse 3 3
Incorrect Measurement 3 3
Separation Problem 3 3
Material Too Soft/Flexible 3 3
Noise, Audible 2 2
Device Slipped 2 2
No Flow 2 2
Obstruction of Flow 2 2
Positioning Failure 2 2
Device Packaging Compromised 2 2
Gas/Air Leak 2 2
Human Factors Issue 2 2
Material Protrusion/Extrusion 2 2
Device Contamination with Body Fluid 2 2
Partial Blockage 2 2
Inadequacy of Device Shape and/or Size 2 2
Unexpected Therapeutic Results 1 1
Decrease in Pressure 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Mushroomed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7471 7471
No Clinical Signs, Symptoms or Conditions 3044 3044
No Patient Involvement 671 671
No Known Impact Or Consequence To Patient 338 338
Insufficient Information 148 148
Vascular Dissection 142 142
Device Embedded In Tissue or Plaque 116 116
Death 106 106
Foreign Body In Patient 97 97
Intimal Dissection 93 93
Myocardial Infarction 87 87
Low Blood Pressure/ Hypotension 66 66
Perforation 56 56
Perforation of Vessels 52 52
Cardiac Arrest 52 52
Occlusion 51 51
Obstruction/Occlusion 51 51
Patient Problem/Medical Problem 44 44
Injury 40 40
Air Embolism 37 37
Angina 36 36
Bradycardia 35 35
Chest Pain 34 34
Non specific EKG/ECG Changes 31 31
Ischemia 31 31
No Code Available 31 31
Arrhythmia 28 28
Hematoma 26 26
Vessel Or Plaque, Device Embedded In 22 22
Cardiogenic Shock 20 20
Unspecified Tissue Injury 19 19
No Information 18 18
Stenosis 17 17
Thrombosis 16 16
Embolism/Embolus 15 15
Ventricular Fibrillation 15 15
High Blood Pressure/ Hypertension 15 15
Thrombosis/Thrombus 14 14
Hemorrhage/Bleeding 13 13
Pain 13 13
Embolism 12 12
Cardiac Tamponade 12 12
Pericardial Effusion 12 12
Vasoconstriction 11 11
Stroke/CVA 11 11
Tachycardia 10 10
Calcium Deposits/Calcification 8 8
Thrombus 8 8
Pulmonary Edema 8 8
ST Segment Elevation 8 8
Respiratory Failure 7 7
Dyspnea 5 5
Blood Loss 5 5
Unspecified Infection 5 5
Rupture 4 4
Shock 4 4
Cardiac Enzyme Elevation 4 4
Restenosis 4 4
Heart Failure 3 3
Multiple Organ Failure 3 3
Ventricular Tachycardia 3 3
Cardiopulmonary Arrest 3 3
Extravasation 3 3
Aneurysm 3 3
Fistula 3 3
Atrial Fibrillation 3 3
Discomfort 3 3
Anxiety 2 2
Chest Tightness/Pressure 2 2
Cardiac Perforation 2 2
Respiratory Distress 2 2
Seizures 2 2
Fatigue 2 2
Discharge 2 2
Unspecified Heart Problem 2 2
Unintended Radiation Exposure 2 2
Hypersensitivity/Allergic reaction 2 2
Renal Failure 2 2
Syncope/Fainting 2 2
Tissue Damage 2 2
Nausea 1 1
Reocclusion 1 1
Vascular System (Circulation), Impaired 1 1
Pseudoaneurysm 1 1
Diminished Pulse Pressure 1 1
Hypoxia 1 1
Anaphylactic Shock 1 1
Heart Block 1 1
Liver Failure 1 1
Brain Injury 1 1
Swelling/ Edema 1 1
Transient Ischemic Attack 1 1
Intracranial Hemorrhage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Prolapse 1 1
Convulsion/Seizure 1 1
Fever 1 1
Gastritis 1 1
Atrial Tachycardia 1 1
Anemia 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 Inc II Aug-01-2022
5 Medtronic Vascular Galway DBA Medtronic Ireland II Oct-11-2019
6 Medtronic Vascular Galway DBA Medtronic Ireland II Sep-20-2017
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