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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 VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, IRELAND
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SINO MEDICAL SCIENCES TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIS MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VERGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1737 1740
2022 1816 1817
2023 1720 1721
2024 1804 1804
2025 1922 1922
2026 708 708

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5335 5335
Difficult to Remove 1080 1080
Difficult to Advance 1049 1049
Adverse Event Without Identified Device or Use Problem 854 854
Break 721 722
Failure to Advance 600 600
Material Separation 534 534
Deflation Problem 473 473
Improper or Incorrect Procedure or Method 451 451
Burst Container or Vessel 322 322
Material Deformation 314 314
Inflation Problem 311 311
Detachment of Device or Device Component 291 291
Leak/Splash 240 240
Entrapment of Device 230 230
Failure to Deflate 178 178
Nonstandard Device 149 149
Deformation Due to Compressive Stress 125 125
Material Split, Cut or Torn 106 106
Material Integrity Problem 103 103
Off-Label Use 68 68
Failure to Fold 64 64
Device Markings/Labelling Problem 56 56
Fracture 41 41
Defective Device 32 32
Material Puncture/Hole 30 30
Device-Device Incompatibility 26 26
Use of Device Problem 24 24
Difficult to Open or Remove Packaging Material 24 24
Physical Resistance/Sticking 24 24
Contamination 21 21
Stretched 20 20
Device Damaged by Another Device 19 19
Difficult to Insert 18 18
Device Contamination with Chemical or Other Material 18 18
Positioning Problem 17 17
Device Dislodged or Dislocated 15 15
Packaging Problem 15 15
Component Missing 13 13
Obstruction of Flow 13 13
Illegible Information 12 12
Insufficient Device Problem Information 10 10
Product Quality Problem 9 9
Unsealed Device Packaging 9 9
Fluid/Blood Leak 8 8
Patient-Device Incompatibility 7 7
Tear, Rip or Hole in Device Packaging 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Contamination /Decontamination Problem 5 5
Material Twisted/Bent 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8242 8243
Insufficient Information 317 318
Vascular Dissection 248 248
Myocardial Infarction 178 178
Foreign Body In Patient 162 163
Obstruction/Occlusion 138 138
Cardiac Arrest 136 136
Perforation of Vessels 123 123
Cardiogenic Shock 110 110
Device Embedded In Tissue or Plaque 101 101
Hemorrhage/Blood Loss/Bleeding 94 94
Heart Failure/Congestive Heart Failure 90 90
Low Blood Pressure/ Hypotension 82 82
No Consequences Or Impact To Patient 75 75
Arrhythmia 67 67
Chest Pain 62 62
Hematoma 58 59
Perforation 58 59
Embolism/Embolus 53 53
Ischemia 47 47
Unspecified Kidney or Urinary Problem 45 45
Thrombosis/Thrombus 39 39
Non specific EKG/ECG Changes 39 39
Angina 37 37
Unspecified Heart Problem 29 29
Bradycardia 26 26
Air Embolism 26 26
Pericardial Effusion 20 20
Cardiac Tamponade 18 18
Unspecified Tissue Injury 18 18
Ventricular Fibrillation 16 16
Tachycardia 15 15
High Blood Pressure/ Hypertension 15 15
Pain 15 15
Reduced Blood Flow 14 14
Stenosis 11 11
Vasoconstriction 11 11
Restenosis 10 10
Atrial Fibrillation 9 9
No Patient Involvement 9 9
Hypoxia 7 7
Unspecified Infection 7 7
Dyspnea 7 7
Extravasation 6 7
Pulmonary Edema 6 6
Retroperitoneal Hemorrhage 6 6
Stroke/CVA 5 5
Discomfort 5 5
Foreign Body Embolism 5 5
Pseudoaneurysm 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc II Aug-01-2022
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