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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
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 1229 1229

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5640 5640
Difficult to Remove 1402 1402
Break 1331 1331
Failure to Advance 872 872
Deflation Problem 739 739
Improper or Incorrect Procedure or Method 641 641
Material Separation 597 597
Difficult to Advance 586 586
Inflation Problem 551 551
Adverse Event Without Identified Device or Use Problem 443 443
Detachment Of Device Component 410 410
Burst Container or Vessel 370 370
Leak/Splash 330 330
Detachment of Device or Device Component 276 276
Material Deformation 245 245
Entrapment of Device 206 206
Physical Resistance 183 183
Kinked 127 127
Deformation Due to Compressive Stress 116 116
Nonstandard Device 103 103
Fracture 95 95
Difficult To Position 74 74
Stretched 72 72
Material Split, Cut or Torn 71 71
Material Integrity Problem 63 63
Failure to Fold 59 59
Device Markings/Labelling Problem 57 57
Device Damaged Prior to Use 52 52
Off-Label Use 49 49
Material Puncture/Hole 37 37
Physical Resistance/Sticking 35 35
Difficult to Open or Remove Packaging Material 34 34
Device Contamination with Chemical or Other Material 34 34
Failure to Deflate 29 29
Folded 27 27
Defective Device 27 27
Hole In Material 26 26
Physical Property Issue 26 26
Unsealed Device Packaging 25 25
Difficult to Insert 24 24
Use of Device Problem 23 23
Torn Material 22 22
Device Dislodged or Dislocated 20 20
Product Quality Problem 19 19
Contamination 18 18
Unintended System Motion 17 17
Component Missing 15 15
Device Damaged by Another Device 15 15
Device-Device Incompatibility 14 14
Positioning Problem 13 13
Material Perforation 12 12
Tear, Rip or Hole in Device Packaging 11 11
Material Fragmentation 11 11
Loose or Intermittent Connection 11 11
Insufficient Information 11 11
Device Issue 10 10
Difficult or Delayed Positioning 9 9
Packaging Problem 9 9
Fluid Leak 8 8
Sticking 8 8
Peeled/Delaminated 7 7
Material Twisted/Bent 7 7
Activation, Positioning or SeparationProblem 7 7
Device Operates Differently Than Expected 7 7
Patient-Device Incompatibility 7 7
Contamination /Decontamination Problem 6 6
Defective Component 6 6
Bent 6 6
Device Expiration Issue 5 5
Mechanical Problem 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Handling Problem 5 5
Mechanical Jam 4 4
Device Operational Issue 4 4
Crack 4 4
Collapse 3 3
Incorrect Measurement 3 3
Migration or Expulsion of Device 3 3
Retraction Problem 3 3
Material Too Rigid or Stiff 3 3
Material Too Soft/Flexible 3 3
Separation Problem 3 3
Noise, Audible 2 2
Device Packaging Compromised 2 2
No Flow 2 2
Gas Leak 2 2
Human Factors Issue 2 2
Material Protrusion/Extrusion 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Device Contamination with Body Fluid 2 2
Partial Blockage 2 2
Positioning Failure 2 2
Air Leak 1 1
Filling Problem 1 1
Flaked 1 1
Decrease in Suction 1 1
Occlusion Within Device 1 1
Device Abrasion From Instrument Or Another Object 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 2657 2657
No Patient Involvement 671 671
No Known Impact Or Consequence To Patient 338 338
Insufficient Information 140 140
Vascular Dissection 135 135
Device Embedded In Tissue or Plaque 115 115
Death 106 106
Intimal Dissection 93 93
Foreign Body In Patient 86 86
Myocardial Infarction 84 84
Low Blood Pressure/ Hypotension 65 65
Perforation 55 55
Perforation of Vessels 52 52
Cardiac Arrest 52 52
Occlusion 51 51
Patient Problem/Medical Problem 44 44
Obstruction/Occlusion 43 43
Injury 40 40
Air Embolism 36 36
Angina 35 35
Chest Pain 33 33
Bradycardia 33 33
No Code Available 31 31
Ischemia 29 29
Arrhythmia 28 28
Non specific EKG/ECG Changes 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
Ventricular Fibrillation 15 15
High Blood Pressure/ Hypertension 14 14
Embolism/Embolus 14 14
Pain 13 13
Hemorrhage/Bleeding 12 12
Embolism 12 12
Pericardial Effusion 12 12
Cardiac Tamponade 12 12
Thrombosis/Thrombus 11 11
Stroke/CVA 11 11
Vasoconstriction 11 11
Tachycardia 10 10
Thrombus 8 8
ST Segment Elevation 8 8
Pulmonary Edema 8 8
Calcium Deposits/Calcification 7 7
Respiratory Failure 7 7
Blood Loss 5 5
Dyspnea 5 5
Unspecified Infection 5 5
Shock 4 4
Rupture 4 4
Cardiac Enzyme Elevation 4 4
Extravasation 3 3
Fistula 3 3
Cardiopulmonary Arrest 3 3
Aneurysm 3 3
Heart Failure 3 3
Ventricular Tachycardia 3 3
Discomfort 3 3
Restenosis 3 3
Multiple Organ Failure 3 3
Syncope/Fainting 2 2
Cardiac Perforation 2 2
Chest Tightness/Pressure 2 2
Tissue Damage 2 2
Anxiety 2 2
Discharge 2 2
Seizures 2 2
Renal Failure 2 2
Respiratory Distress 2 2
Atrial Fibrillation 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 1 1
Failure of Implant 1 1
Gastritis 1 1
Intracranial Hemorrhage 1 1
Fatigue 1 1
Fever 1 1
Electro-Mechanical Dissociation 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Atrial Tachycardia 1 1
Exposure to Body Fluids 1 1
Atherosclerosis 1 1
Anaphylactic Shock 1 1
Anemia 1 1
Syncope 1 1
Pneumonia 1 1
Infiltration into Tissue 1 1
Reocclusion 1 1
Nausea 1 1
Brain Injury 1 1
Transient Ischemic Attack 1 1
Prolapse 1 1
Pseudoaneurysm 1 1
Diminished Pulse Pressure 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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