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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
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 1291 1291

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5642 5642
Difficult to Remove 1193 1193
Break 1117 1117
Difficult to Advance 837 837
Material Separation 726 726
Failure to Advance 647 647
Deflation Problem 588 588
Improper or Incorrect Procedure or Method 545 545
Adverse Event Without Identified Device or Use Problem 460 460
Inflation Problem 372 372
Burst Container or Vessel 340 340
Material Deformation 310 310
Leak/Splash 306 306
Detachment of Device or Device Component 305 305
Entrapment of Device 235 235
Deformation Due to Compressive Stress 139 139
Failure to Deflate 127 127
Material Split, Cut or Torn 114 114
Fracture 99 99
Material Integrity Problem 89 89
Off-Label Use 88 88
Device Markings/Labelling Problem 77 77
Failure to Fold 70 70
Stretched 41 41
Material Puncture/Hole 36 36
Physical Resistance/Sticking 33 33
Defective Device 33 33
Contamination 27 27
Use of Device Problem 26 26
Difficult to Insert 22 22
Device-Device Incompatibility 21 21
Device Dislodged or Dislocated 21 21
Difficult to Open or Remove Packaging Material 20 20
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 11 11
Material Twisted/Bent 10 10
Loose or Intermittent Connection 9 9
Insufficient Information 9 9
Device Damaged by Another Device 8 8
Difficult or Delayed Positioning 8 8
Material Fragmentation 8 8
Patient-Device Incompatibility 8 8
Obstruction of Flow 6 6
Device Contaminated During Manufacture or Shipping 6 6
Positioning Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5854 5854
No Consequences Or Impact To Patient 3453 3453
Insufficient Information 256 256
No Patient Involvement 235 235
Vascular Dissection 191 191
No Known Impact Or Consequence To Patient 163 163
Myocardial Infarction 123 123
Device Embedded In Tissue or Plaque 113 113
Foreign Body In Patient 111 111
Obstruction/Occlusion 102 102
Perforation of Vessels 81 81
Low Blood Pressure/ Hypotension 78 78
Arrhythmia 54 54
Perforation 53 53
Cardiac Arrest 48 48
Angina 44 44
Air Embolism 40 40
Injury 39 39
Ischemia 39 39
Embolism/Embolus 39 39
Chest Pain 36 36
Hematoma 34 34
Non specific EKG/ECG Changes 32 32
Thrombosis/Thrombus 30 30
Occlusion 30 30
Death 28 28
Bradycardia 26 26
Hemorrhage/Bleeding 25 25
No Code Available 23 23
Intimal Dissection 21 21
Unspecified Heart Problem 20 20
High Blood Pressure/ Hypertension 19 19
Unspecified Tissue Injury 19 19
Stenosis 19 19
Cardiogenic Shock 17 17
Vessel Or Plaque, Device Embedded In 16 16
Pericardial Effusion 16 16
Pain 14 14
Ventricular Fibrillation 14 14
Tachycardia 13 13
Vasoconstriction 11 11
Atrial Fibrillation 10 10
Embolism 9 9
Stroke/CVA 9 9
Unspecified Infection 9 9
Heart Failure/Congestive Heart Failure 8 8
Cardiac Tamponade 8 8
Shock 7 7
Pulmonary Edema 7 7
Dyspnea 6 6

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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