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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

MDR Year MDR Reports MDR Events
2019 2102 2102
2020 1974 1974
2021 1738 1738
2022 1816 1816
2023 1723 1723
2024 444 444

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5142 5142
Difficult to Remove 1113 1113
Break 1076 1076
Difficult to Advance 747 747
Material Separation 685 685
Failure to Advance 604 604
Deflation Problem 535 535
Improper or Incorrect Procedure or Method 503 503
Adverse Event Without Identified Device or Use Problem 409 409
Inflation Problem 337 337
Burst Container or Vessel 306 306
Leak/Splash 286 286
Detachment of Device or Device Component 277 277
Material Deformation 270 270
Entrapment of Device 206 206
Deformation Due to Compressive Stress 132 132
Material Split, Cut or Torn 98 98
Fracture 97 97
Failure to Deflate 94 94
Off-Label Use 80 80
Material Integrity Problem 80 80
Device Markings/Labelling Problem 74 74
Failure to Fold 61 61
Stretched 41 41
Material Puncture/Hole 36 36
Defective Device 32 32
Physical Resistance/Sticking 31 31
Contamination 25 25
Use of Device Problem 23 23
Device-Device Incompatibility 20 20
Device Dislodged or Dislocated 18 18
Difficult to Insert 18 18
Unintended System Motion 16 16
Unsealed Device Packaging 16 16
Device Contamination with Chemical or Other Material 16 16
Difficult to Open or Remove Packaging Material 15 15
Packaging Problem 15 15
Product Quality Problem 15 15
Tear, Rip or Hole in Device Packaging 11 11
Loose or Intermittent Connection 9 9
Material Fragmentation 8 8
Difficult or Delayed Positioning 8 8
Patient-Device Incompatibility 8 8
Material Twisted/Bent 8 8
Insufficient Information 7 7
Component Missing 7 7
Device Damaged by Another Device 7 7
Device Contaminated During Manufacture or Shipping 6 6
Fluid/Blood Leak 6 6
Material Perforation 5 5
Positioning Problem 5 5
Contamination /Decontamination Problem 5 5
Patient Device Interaction Problem 4 4
Peeled/Delaminated 4 4
Device Difficult to Setup or Prepare 3 3
Defective Component 3 3
Mechanical Jam 3 3
Activation, Positioning or Separation Problem 3 3
Obstruction of Flow 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Material Too Soft/Flexible 3 3
Wrong Label 2 2
Separation Problem 2 2
Gas/Air Leak 2 2
No Flow 2 2
No Apparent Adverse Event 2 2
Noise, Audible 2 2
Retraction Problem 2 2
Material Too Rigid or Stiff 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 1 1
Flaked 1 1
Device Damaged Prior to Use 1 1
Unexpected Therapeutic Results 1 1
Unraveled Material 1 1
Inadequacy of Device Shape and/or Size 1 1
Component Misassembled 1 1
Explosion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Pressure Problem 1 1
Misassembly by Users 1 1
Connection Problem 1 1
Illegible Information 1 1
Air/Gas in Device 1 1
Poor Visibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5098 5098
No Consequences Or Impact To Patient 3453 3453
No Patient Involvement 235 235
Insufficient Information 225 225
No Known Impact Or Consequence To Patient 163 163
Vascular Dissection 160 160
Myocardial Infarction 113 113
Device Embedded In Tissue or Plaque 105 105
Foreign Body In Patient 100 100
Obstruction/Occlusion 85 85
Low Blood Pressure/ Hypotension 68 68
Perforation of Vessels 66 66
Perforation 49 49
Cardiac Arrest 46 46
Arrhythmia 44 44
Angina 39 39
Injury 39 39
Air Embolism 38 38
Ischemia 37 37
Hematoma 33 33
Occlusion 30 30
Non specific EKG/ECG Changes 29 29
Chest Pain 29 29
Death 28 28
Embolism/Embolus 28 28
Thrombosis/Thrombus 24 24
Bradycardia 24 24
No Code Available 23 23
Hemorrhage/Bleeding 22 22
Intimal Dissection 21 21
High Blood Pressure/ Hypertension 19 19
Unspecified Tissue Injury 19 19
Cardiogenic Shock 17 17
Stenosis 17 17
Vessel Or Plaque, Device Embedded In 16 16
Ventricular Fibrillation 14 14
Pain 14 14
Pericardial Effusion 14 14
Tachycardia 12 12
Vasoconstriction 11 11
Unspecified Heart Problem 10 10
Atrial Fibrillation 9 9
Stroke/CVA 9 9
Unspecified Infection 9 9
Embolism 9 9
Cardiac Tamponade 7 7
Pulmonary Edema 7 7
Heart Failure/Congestive Heart Failure 7 7
Restenosis 6 6
Thrombosis 6 6
Thrombus 6 6
Dyspnea 6 6
Hypoxia 5 5
Shock 5 5
Patient Problem/Medical Problem 5 5
No Information 5 5
Cardiac Enzyme Elevation 4 4
Calcium Deposits/Calcification 4 4
Aneurysm 4 4
Extravasation 3 3
Fatigue 3 3
Fistula 3 3
Hypersensitivity/Allergic reaction 3 3
Renal Failure 3 3
Multiple Organ Failure 3 3
Respiratory Failure 3 3
Blood Loss 3 3
Pseudoaneurysm 2 2
Cardiac Perforation 2 2
Chest Tightness/Pressure 2 2
Unintended Radiation Exposure 2 2
Syncope/Fainting 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Heart Block 2 2
ST Segment Elevation 2 2
Seizures 2 2
Anxiety 2 2
Discomfort 2 2
Rupture 2 2
Ventricular Tachycardia 2 2
Failure of Implant 2 2
Fever 2 2
Intracranial Hemorrhage 1 1
Hemoptysis 1 1
Laceration(s) 1 1
Syncope 1 1
Anaphylactic Shock 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Great Vessel Perforation 1 1
Heart Failure 1 1
Post Operative Wound Infection 1 1
Tissue Damage 1 1
Transient Ischemic Attack 1 1
Local Reaction 1 1
Pneumonia 1 1
Reocclusion 1 1
Nausea 1 1
Foreign Body Embolism 1 1
Convulsion/Seizure 1 1
Mitral Valve Insufficiency/ Regurgitation 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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