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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 2
DONGGUAN TT MEDICAL, INC
  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
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINO MEDICAL SCIENCES TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SIS MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2225 2225
2019 2102 2102
2020 1974 1974
2021 1738 1738
2022 1816 1816
2023 1141 1141

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5500 5500
Break 1229 1229
Difficult to Remove 1199 1199
Failure to Advance 789 789
Difficult to Advance 734 734
Material Separation 711 711
Deflation Problem 610 610
Improper or Incorrect Procedure or Method 565 565
Adverse Event Without Identified Device or Use Problem 459 459
Inflation Problem 378 378
Burst Container or Vessel 372 372
Detachment of Device or Device Component 302 302
Leak/Splash 297 297
Material Deformation 274 274
Entrapment of Device 214 214
Deformation Due to Compressive Stress 139 139
Detachment Of Device Component 137 137
Fracture 98 98
Material Split, Cut or Torn 89 89
Device Markings/Labelling Problem 81 81
Material Integrity Problem 73 73
Failure to Fold 67 67
Off-Label Use 67 67
Failure to Deflate 64 64
Stretched 49 49
Physical Resistance 49 49
Material Puncture/Hole 42 42
Physical Resistance/Sticking 39 39
Kinked 38 38
Defective Device 32 32
Use of Device Problem 26 26
Difficult To Position 25 25
Contamination 25 25
Unsealed Device Packaging 24 24
Device Dislodged or Dislocated 23 23
Device Contamination with Chemical or Other Material 19 19
Device-Device Incompatibility 19 19
Device Damaged Prior to Use 19 19
Unintended System Motion 17 17
Product Quality Problem 17 17
Difficult to Insert 17 17
Packaging Problem 16 16
Difficult to Open or Remove Packaging Material 14 14
Folded 12 12
Material Fragmentation 11 11
Physical Property Issue 11 11
Positioning Problem 11 11
Insufficient Information 10 10
Device Damaged by Another Device 10 10
Tear, Rip or Hole in Device Packaging 9 9
Component Missing 9 9
Difficult or Delayed Positioning 9 9
Loose or Intermittent Connection 9 9
Device Issue 8 8
Sticking 8 8
Patient-Device Incompatibility 8 8
Hole In Material 7 7
Fluid/Blood Leak 7 7
Material Twisted/Bent 7 7
Contamination /Decontamination Problem 6 6
Material Perforation 6 6
Defective Component 6 6
Peeled/Delaminated 5 5
Device Contaminated During Manufacture or Shipping 5 5
Torn Material 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
Patient Device Interaction Problem 3 3
Material Too Soft/Flexible 3 3
Wrong Label 2 2
Component Misassembled 2 2
No Flow 2 2
Noise, Audible 2 2
Gas/Air Leak 2 2
Human Factors Issue 2 2
Device Difficult to Setup or Prepare 2 2
Migration or Expulsion of Device 2 2
Incorrect Measurement 2 2
Obstruction of Flow 2 2
Device Slipped 2 2
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1
Device Or Device Fragments Location Unknown 1 1
Connection Problem 1 1
Delamination 1 1
Decrease in Pressure 1 1
Inadequacy of Device Shape and/or Size 1 1
Air Leak 1 1
Filling Problem 1 1
Flaked 1 1
Human-Device Interface Problem 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 4193 4193
No Patient Involvement 380 380
No Known Impact Or Consequence To Patient 272 272
Insufficient Information 189 189
Vascular Dissection 161 161
Device Embedded In Tissue or Plaque 114 114
Myocardial Infarction 109 109
Foreign Body In Patient 94 94
Obstruction/Occlusion 69 69
Death 67 67
Low Blood Pressure/ Hypotension 62 62
Perforation of Vessels 59 59
Perforation 54 54
Cardiac Arrest 44 44
Intimal Dissection 43 43
Angina 42 42
Occlusion 40 40
Injury 40 40
Ischemia 39 39
Air Embolism 37 37
Arrhythmia 35 35
Chest Pain 31 31
Hematoma 30 30
Bradycardia 28 28
Non specific EKG/ECG Changes 27 27
Patient Problem/Medical Problem 27 27
No Code Available 27 27
Stenosis 21 21
Embolism/Embolus 20 20
Thrombosis/Thrombus 20 20
Unspecified Tissue Injury 19 19
Hemorrhage/Bleeding 18 18
Vessel Or Plaque, Device Embedded In 17 17
Cardiogenic Shock 17 17
High Blood Pressure/ Hypertension 16 16
Vasoconstriction 15 15
Ventricular Fibrillation 15 15
Pericardial Effusion 14 14
Thrombosis 13 13
Pain 12 12
No Information 12 12
Tachycardia 11 11
Embolism 11 11
Cardiac Tamponade 10 10
Thrombus 7 7
ST Segment Elevation 7 7
Pulmonary Edema 7 7
Atrial Fibrillation 7 7
Stroke/CVA 7 7
Calcium Deposits/Calcification 6 6
Unspecified Infection 6 6
Respiratory Failure 6 6
Restenosis 5 5
Dyspnea 5 5
Cardiac Enzyme Elevation 4 4
Shock 4 4
Blood Loss 4 4
Heart Failure/Congestive Heart Failure 4 4
Multiple Organ Failure 3 3
Ventricular Tachycardia 3 3
Rupture 3 3
Extravasation 3 3
Fistula 3 3
Aneurysm 3 3
Fatigue 2 2
Fever 2 2
Hypersensitivity/Allergic reaction 2 2
Heart Failure 2 2
Anxiety 2 2
Discomfort 2 2
Failure of Implant 2 2
Seizures 2 2
Renal Failure 2 2
Syncope/Fainting 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Heart Block 2 2
Unspecified Heart Problem 2 2
Pseudoaneurysm 2 2
Cardiac Perforation 2 2
Chest Tightness/Pressure 2 2
Unintended Radiation Exposure 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Prolapse 1 1
Post Operative Wound Infection 1 1
Loss Of Pulse 1 1
Vascular System (Circulation), Impaired 1 1
Low Cardiac Output 1 1
Diminished Pulse Pressure 1 1
Test Result 1 1
Respiratory Insufficiency 1 1
Liver Failure 1 1
Renal Impairment 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Foreign Body Embolism 1 1
Convulsion/Seizure 1 1
Local Reaction 1 1
Pneumonia 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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