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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 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
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINO MEDICAL SCIENCES TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SIS MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2102 2102
2020 1974 1974
2021 1738 1738
2022 1816 1816
2023 1723 1723
2024 1657 1657

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5862 5862
Difficult to Remove 1231 1231
Break 1137 1137
Difficult to Advance 878 878
Material Separation 741 741
Failure to Advance 660 660
Deflation Problem 616 616
Improper or Incorrect Procedure or Method 565 565
Adverse Event Without Identified Device or Use Problem 480 480
Inflation Problem 386 386
Burst Container or Vessel 360 360
Material Deformation 334 334
Detachment of Device or Device Component 320 320
Leak/Splash 318 318
Entrapment of Device 249 249
Deformation Due to Compressive Stress 146 146
Failure to Deflate 137 137
Material Split, Cut or Torn 120 120
Fracture 102 102
Material Integrity Problem 92 92
Off-Label Use 90 90
Device Markings/Labelling Problem 77 77
Failure to Fold 72 72
Stretched 43 43
Material Puncture/Hole 38 38
Physical Resistance/Sticking 35 35
Defective Device 34 34
Use of Device Problem 28 28
Contamination 27 27
Difficult to Insert 25 25
Difficult to Open or Remove Packaging Material 22 22
Device-Device Incompatibility 21 21
Device Dislodged or Dislocated 21 21
Product Quality Problem 19 19
Unsealed Device Packaging 17 17
Device Contamination with Chemical or Other Material 17 17
Unintended System Motion 16 16
Packaging Problem 16 16
Component Missing 13 13
Tear, Rip or Hole in Device Packaging 12 12
Device Damaged by Another Device 10 10
Insufficient Information 9 9
Loose or Intermittent Connection 9 9
Difficult or Delayed Positioning 8 8
Material Twisted/Bent 8 8
Material Fragmentation 8 8
Patient-Device Incompatibility 8 8
Positioning Problem 8 8
Obstruction of Flow 6 6
Fluid/Blood Leak 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6175 6175
No Consequences Or Impact To Patient 3453 3453
Insufficient Information 276 276
No Patient Involvement 235 235
Vascular Dissection 194 194
No Known Impact Or Consequence To Patient 163 163
Myocardial Infarction 126 126
Foreign Body In Patient 122 122
Device Embedded In Tissue or Plaque 119 119
Obstruction/Occlusion 107 107
Perforation of Vessels 83 83
Low Blood Pressure/ Hypotension 79 79
Arrhythmia 55 55
Perforation 53 53
Cardiac Arrest 51 51
Angina 44 44
Air Embolism 42 42
Ischemia 40 40
Embolism/Embolus 40 40
Chest Pain 39 39
Injury 39 39
Non specific EKG/ECG Changes 36 36
Hematoma 34 34
Thrombosis/Thrombus 31 31
Occlusion 30 30
Death 28 28
Bradycardia 26 26
Hemorrhage/Bleeding 25 25
No Code Available 23 23
Intimal Dissection 21 21
Cardiogenic Shock 21 21
Unspecified Heart Problem 20 20
Unspecified Tissue Injury 19 19
Stenosis 19 19
High Blood Pressure/ Hypertension 19 19
Pericardial Effusion 17 17
Vessel Or Plaque, Device Embedded In 16 16
Ventricular Fibrillation 15 15
Pain 14 14
Tachycardia 13 13
Vasoconstriction 11 11
Atrial Fibrillation 10 10
Unspecified Infection 9 9
Embolism 9 9
Stroke/CVA 9 9
Heart Failure/Congestive Heart Failure 8 8
Cardiac Tamponade 8 8
Restenosis 7 7
Pulmonary Edema 7 7
Shock 7 7

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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