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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
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2020 1974 1974
2021 1738 1738
2022 1816 1816
2023 1723 1723
2024 1807 1807
2025 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5146 5146
Difficult to Remove 1067 1067
Break 842 842
Difficult to Advance 815 815
Material Separation 531 531
Failure to Advance 526 526
Deflation Problem 492 492
Improper or Incorrect Procedure or Method 443 443
Adverse Event Without Identified Device or Use Problem 403 403
Inflation Problem 312 312
Burst Container or Vessel 303 303
Detachment of Device or Device Component 286 286
Material Deformation 277 277
Leak/Splash 252 252
Entrapment of Device 216 216
Failure to Deflate 141 141
Material Split, Cut or Torn 107 107
Deformation Due to Compressive Stress 99 99
Fracture 90 90
Material Integrity Problem 87 87
Off-Label Use 71 71
Device Markings/Labelling Problem 64 64
Failure to Fold 57 57
Stretched 31 31
Defective Device 29 29
Material Puncture/Hole 25 25
Use of Device Problem 25 25
Contamination 23 23
Physical Resistance/Sticking 23 23
Device-Device Incompatibility 21 21
Device Dislodged or Dislocated 20 20
Difficult to Insert 17 17
Difficult to Open or Remove Packaging Material 17 17
Device Contamination with Chemical or Other Material 14 14
Component Missing 13 13
Product Quality Problem 13 13
Packaging Problem 13 13
Unintended System Motion 12 12
Unsealed Device Packaging 11 11
Positioning Problem 10 10
Tear, Rip or Hole in Device Packaging 10 10
Device Damaged by Another Device 9 9
Insufficient Information 8 8
Patient-Device Incompatibility 8 8
Difficult or Delayed Positioning 7 7
Material Fragmentation 7 7
Obstruction of Flow 7 7
Material Twisted/Bent 6 6
Contamination /Decontamination Problem 5 5
Device Misassembled During Manufacturing /Shipping 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6432 6432
No Consequences Or Impact To Patient 1720 1720
Insufficient Information 288 288
Vascular Dissection 170 170
Foreign Body In Patient 117 117
Myocardial Infarction 114 114
Obstruction/Occlusion 107 107
Device Embedded In Tissue or Plaque 104 104
No Patient Involvement 91 91
Perforation of Vessels 77 77
No Known Impact Or Consequence To Patient 74 74
Low Blood Pressure/ Hypotension 71 71
Arrhythmia 52 52
Cardiac Arrest 44 44
Perforation 44 44
Embolism/Embolus 41 41
Chest Pain 41 41
Angina 40 40
Ischemia 37 37
Air Embolism 35 35
Non specific EKG/ECG Changes 34 34
Thrombosis/Thrombus 32 32
Hematoma 28 28
Hemorrhage/Bleeding 24 24
Death 23 23
Bradycardia 23 23
Injury 20 20
Unspecified Heart Problem 20 20
Cardiogenic Shock 19 19
Unspecified Tissue Injury 19 19
Ventricular Fibrillation 15 15
No Code Available 15 15
High Blood Pressure/ Hypertension 14 14
Pain 14 14
Tachycardia 13 13
Pericardial Effusion 12 12
Vasoconstriction 11 11
Stenosis 10 10
Atrial Fibrillation 9 9
Heart Failure/Congestive Heart Failure 8 8
Occlusion 7 7
Unspecified Infection 7 7
Pulmonary Edema 7 7
Restenosis 7 7
Vessel Or Plaque, Device Embedded In 6 6
Dyspnea 6 6
Shock 6 6
Cardiac Tamponade 5 5
Intimal Dissection 5 5
Stroke/CVA 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Feb-14-2020
2 Medtronic Inc II Aug-01-2022
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