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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
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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