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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 1721 1721
2024 1808 1808
2025 1103 1103

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5500 5500
Difficult to Remove 1149 1149
Difficult to Advance 905 905
Break 885 885
Adverse Event Without Identified Device or Use Problem 802 802
Material Separation 573 573
Failure to Advance 553 553
Deflation Problem 538 538
Improper or Incorrect Procedure or Method 481 481
Inflation Problem 337 337
Burst Container or Vessel 322 322
Detachment of Device or Device Component 313 313
Material Deformation 309 309
Leak/Splash 269 269
Entrapment of Device 229 229
Failure to Deflate 152 152
Material Split, Cut or Torn 116 116
Deformation Due to Compressive Stress 109 109
Material Integrity Problem 100 100
Fracture 93 93
Off-Label Use 72 72
Device Markings/Labelling Problem 64 64
Failure to Fold 61 61
Defective Device 34 34
Stretched 31 31
Physical Resistance/Sticking 29 29
Material Puncture/Hole 28 28
Use of Device Problem 28 28
Contamination 24 24
Device Dislodged or Dislocated 21 21
Device-Device Incompatibility 21 21
Difficult to Open or Remove Packaging Material 19 19
Difficult to Insert 18 18
Device Contamination with Chemical or Other Material 17 17
Device Damaged by Another Device 15 15
Component Missing 14 14
Product Quality Problem 13 13
Packaging Problem 13 13
Unintended System Motion 12 12
Unsealed Device Packaging 11 11
Tear, Rip or Hole in Device Packaging 10 10
Positioning Problem 10 10
Insufficient Information 8 8
Obstruction of Flow 8 8
Difficult or Delayed Positioning 7 7
Material Fragmentation 7 7
Patient-Device Incompatibility 7 7
Material Twisted/Bent 6 6
Device Misassembled During Manufacturing /Shipping 5 5
Contamination /Decontamination Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6971 6971
No Consequences Or Impact To Patient 1720 1720
Insufficient Information 311 311
Vascular Dissection 220 220
Myocardial Infarction 179 179
Foreign Body In Patient 140 140
Cardiac Arrest 130 130
Cardiogenic Shock 115 115
Obstruction/Occlusion 112 112
Device Embedded In Tissue or Plaque 111 111
Perforation of Vessels 107 107
Hemorrhage/Bleeding 92 92
No Patient Involvement 91 91
Heart Failure/Congestive Heart Failure 90 90
Low Blood Pressure/ Hypotension 81 81
No Known Impact Or Consequence To Patient 74 74
Perforation 62 62
Hematoma 57 57
Arrhythmia 52 52
Chest Pain 45 45
Unspecified Kidney or Urinary Problem 45 45
Embolism/Embolus 44 44
Angina 42 42
Ischemia 41 41
Air Embolism 37 37
Non specific EKG/ECG Changes 37 37
Thrombosis/Thrombus 35 35
Bradycardia 24 24
Death 23 23
Unspecified Heart Problem 20 20
Injury 20 20
Unspecified Tissue Injury 19 19
Pericardial Effusion 16 16
Pain 16 16
Ventricular Fibrillation 15 15
Cardiac Tamponade 15 15
No Code Available 15 15
High Blood Pressure/ Hypertension 14 14
Stenosis 13 13
Tachycardia 13 13
Vasoconstriction 11 11
Atrial Fibrillation 9 9
Restenosis 9 9
Occlusion 7 7
Pulmonary Edema 7 7
Unspecified Infection 7 7
Dyspnea 6 6
Shock 6 6
Extravasation 6 6
Retroperitoneal Hemorrhage 6 6

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