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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 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
2021 1738 1741
2022 1816 1817
2023 1720 1721
2024 1804 1804
2025 1922 1922
2026 247 247

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5083 5084
Difficult to Remove 1048 1048
Difficult to Advance 965 965
Adverse Event Without Identified Device or Use Problem 846 846
Break 717 718
Failure to Advance 571 571
Material Separation 505 505
Deflation Problem 450 450
Improper or Incorrect Procedure or Method 439 439
Inflation Problem 307 308
Burst Container or Vessel 307 307
Material Deformation 293 293
Detachment of Device or Device Component 287 289
Leak/Splash 233 233
Entrapment of Device 228 228
Failure to Deflate 174 174
Deformation Due to Compressive Stress 116 116
Material Split, Cut or Torn 106 106
Material Integrity Problem 102 102
Nonstandard Device 71 71
Off-Label Use 67 67
Failure to Fold 62 62
Device Markings/Labelling Problem 56 56
Fracture 48 48
Defective Device 36 36
Physical Resistance/Sticking 33 33
Material Puncture/Hole 30 30
Device-Device Incompatibility 24 24
Difficult to Open or Remove Packaging Material 23 23
Use of Device Problem 23 23
Contamination 22 22
Device Dislodged or Dislocated 19 19
Stretched 19 19
Difficult to Insert 18 18
Device Damaged by Another Device 18 18
Positioning Problem 16 16
Device Contamination with Chemical or Other Material 15 15
Packaging Problem 13 13
Component Missing 13 13
Illegible Information 12 12
Insufficient Information 10 10
Unsealed Device Packaging 10 10
Product Quality Problem 9 9
Obstruction of Flow 9 9
Tear, Rip or Hole in Device Packaging 7 7
Material Twisted/Bent 7 7
Patient-Device Incompatibility 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Contamination /Decontamination Problem 5 5
No Apparent Adverse Event 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7834 7835
Insufficient Information 311 312
Vascular Dissection 243 243
Myocardial Infarction 176 176
Foreign Body In Patient 142 143
Obstruction/Occlusion 132 132
Cardiac Arrest 132 132
Perforation of Vessels 115 115
Cardiogenic Shock 110 110
Device Embedded In Tissue or Plaque 95 95
Hemorrhage/Bleeding 92 92
Heart Failure/Congestive Heart Failure 90 90
Low Blood Pressure/ Hypotension 80 80
No Consequences Or Impact To Patient 75 75
Arrhythmia 66 66
Chest Pain 58 58
Hematoma 58 59
Perforation 57 58
Embolism/Embolus 52 52
Ischemia 46 46
Unspecified Kidney or Urinary Problem 45 45
Thrombosis/Thrombus 38 38
Non specific EKG/ECG Changes 38 38
Angina 36 36
Unspecified Heart Problem 29 29
Bradycardia 25 25
Air Embolism 25 25
Pericardial Effusion 19 19
Cardiac Tamponade 18 18
Unspecified Tissue Injury 17 17
Tachycardia 15 15
Ventricular Fibrillation 14 14
Pain 14 14
High Blood Pressure/ Hypertension 14 14
Vasoconstriction 11 11
Stenosis 11 11
Restenosis 10 10
No Patient Involvement 9 9
Atrial Fibrillation 9 9
Dyspnea 7 7
Unspecified Infection 7 7
Pulmonary Edema 6 6
Hypoxia 6 6
Extravasation 6 7
Retroperitoneal Hemorrhage 6 6
Shock 5 5
Pseudoaneurysm 5 5
Discomfort 4 4
Nausea 4 4
Stroke/CVA 4 4

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