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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 1
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 911 911

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5423 5423
Difficult to Remove 1162 1162
Break 1105 1105
Difficult to Advance 788 788
Material Separation 705 705
Failure to Advance 619 619
Deflation Problem 570 570
Improper or Incorrect Procedure or Method 524 524
Adverse Event Without Identified Device or Use Problem 432 432
Inflation Problem 349 349
Burst Container or Vessel 322 322
Leak/Splash 294 294
Detachment of Device or Device Component 294 294
Material Deformation 290 290
Entrapment of Device 220 220
Deformation Due to Compressive Stress 134 134
Material Split, Cut or Torn 108 108
Failure to Deflate 105 105
Fracture 98 98
Material Integrity Problem 88 88
Off-Label Use 84 84
Device Markings/Labelling Problem 74 74
Failure to Fold 70 70
Stretched 41 41
Material Puncture/Hole 36 36
Defective Device 33 33
Physical Resistance/Sticking 33 33
Contamination 26 26
Use of Device Problem 24 24
Device-Device Incompatibility 21 21
Device Dislodged or Dislocated 20 20
Difficult to Insert 19 19
Product Quality Problem 18 18
Unsealed Device Packaging 17 17
Device Contamination with Chemical or Other Material 17 17
Difficult to Open or Remove Packaging Material 16 16
Unintended System Motion 16 16
Packaging Problem 15 15
Component Missing 13 13
Tear, Rip or Hole in Device Packaging 11 11
Material Twisted/Bent 10 10
Insufficient Information 9 9
Loose or Intermittent Connection 9 9
Material Fragmentation 8 8
Difficult or Delayed Positioning 8 8
Device Damaged by Another Device 8 8
Patient-Device Incompatibility 8 8
Device Contaminated During Manufacture or Shipping 6 6
Positioning Problem 6 6
Fluid/Blood Leak 6 6
Material Perforation 5 5
Contamination /Decontamination Problem 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Peeled/Delaminated 4 4
Patient Device Interaction Problem 4 4
Material Too Soft/Flexible 3 3
Device Difficult to Setup or Prepare 3 3
Obstruction of Flow 3 3
Defective Component 3 3
Activation, Positioning or Separation Problem 3 3
Mechanical Jam 3 3
No Flow 2 2
No Apparent Adverse Event 2 2
Noise, Audible 2 2
Separation Problem 2 2
Gas/Air Leak 2 2
Retraction Problem 2 2
Material Too Rigid or Stiff 2 2
Mechanical Problem 2 2
Wrong Label 2 2
Component Misassembled 2 2
Explosion 1 1
Air/Gas in Device 1 1
Poor Visibility 1 1
Migration or Expulsion of Device 1 1
Flaked 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Damaged Prior to Use 1 1
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Illegible Information 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Pressure Problem 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5522 5522
No Consequences Or Impact To Patient 3453 3453
Insufficient Information 240 240
No Patient Involvement 235 235
Vascular Dissection 173 173
No Known Impact Or Consequence To Patient 163 163
Myocardial Infarction 113 113
Device Embedded In Tissue or Plaque 109 109
Foreign Body In Patient 109 109
Obstruction/Occlusion 90 90
Low Blood Pressure/ Hypotension 71 71
Perforation of Vessels 69 69
Perforation 52 52
Cardiac Arrest 47 47
Arrhythmia 44 44
Angina 39 39
Ischemia 39 39
Injury 39 39
Air Embolism 38 38
Hematoma 33 33
Chest Pain 32 32
Non specific EKG/ECG Changes 31 31
Occlusion 30 30
Death 28 28
Embolism/Embolus 28 28
Thrombosis/Thrombus 25 25
Hemorrhage/Bleeding 25 25
Bradycardia 24 24
No Code Available 23 23
Intimal Dissection 21 21
High Blood Pressure/ Hypertension 19 19
Unspecified Tissue Injury 19 19
Stenosis 18 18
Cardiogenic Shock 17 17
Vessel Or Plaque, Device Embedded In 16 16
Pericardial Effusion 16 16
Ventricular Fibrillation 14 14
Pain 14 14
Tachycardia 13 13
Vasoconstriction 11 11
Atrial Fibrillation 10 10
Unspecified Heart Problem 10 10
Stroke/CVA 9 9
Embolism 9 9
Unspecified Infection 9 9
Pulmonary Edema 7 7
Cardiac Tamponade 7 7
Heart Failure/Congestive Heart Failure 7 7
Restenosis 6 6
Thrombosis 6 6
Thrombus 6 6
Dyspnea 6 6
Cardiac Enzyme Elevation 5 5
Hypoxia 5 5
Shock 5 5
No Information 5 5
Patient Problem/Medical Problem 5 5
Extravasation 4 4
Calcium Deposits/Calcification 4 4
Aneurysm 4 4
Fatigue 3 3
Fever 3 3
Fistula 3 3
Hypersensitivity/Allergic reaction 3 3
Renal Failure 3 3
Blood Loss 3 3
Respiratory Failure 3 3
Multiple Organ Failure 3 3
Syncope/Fainting 2 2
Cardiac Perforation 2 2
Pseudoaneurysm 2 2
Diminished Pulse Pressure 2 2
Unintended Radiation Exposure 2 2
Heart Block 2 2
Arteriosclerosis/ Atherosclerosis 2 2
ST Segment Elevation 2 2
Seizures 2 2
Rupture 2 2
Ventricular Tachycardia 2 2
Anxiety 2 2
Discomfort 2 2
Chest Tightness/Pressure 2 2
Failure of Implant 2 2
Laceration(s) 1 1
Nausea 1 1
Intracranial Hemorrhage 1 1
Hemoptysis 1 1
Syncope 1 1
Anaphylactic Shock 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Prolapse 1 1
Post Operative Wound Infection 1 1
Great Vessel Perforation 1 1
Heart Failure 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Local Reaction 1 1
Pneumonia 1 1
Reocclusion 1 1
Foreign Body Embolism 1 1

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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