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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
B. BRAUN INTERVENTIONAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDCAPTAIN LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDINOL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2017 2752 2752
2018 2225 2225
2019 2102 2102
2020 1974 1974
2021 1741 1741

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 4943 4943
Difficult to Remove 1241 1241
Break 1203 1203
Failure to Advance 791 791
Deflation Problem 689 689
Improper or Incorrect Procedure or Method 586 586
Material Separation 537 537
Inflation Problem 528 528
Difficult to Advance 478 478
Detachment Of Device Component 410 410
Adverse Event Without Identified Device or Use Problem 406 406
Burst Container or Vessel 332 332
Leak/Splash 291 291
Detachment of Device or Device Component 238 238
Material Deformation 217 217
Physical Resistance 183 183
Entrapment of Device 172 172
Kinked 127 127
Deformation Due to Compressive Stress 108 108
Nonstandard Device 103 103
Fracture 86 86
Difficult To Position 74 74
Stretched 71 71
Material Split, Cut or Torn 65 65
Material Integrity Problem 53 53
Failure to Fold 53 53
Device Damaged Prior to Use 52 52
Off-Label Use 41 41
Device Markings/Labelling Problem 41 41
Material Puncture/Hole 34 34
Device Contamination with Chemical or Other Material 33 33
Physical Resistance/Sticking 32 32
Difficult to Open or Remove Packaging Material 31 31
Folded 27 27
Hole In Material 26 26
Physical Property Issue 26 26
Difficult to Insert 23 23
Unsealed Device Packaging 23 23
Torn Material 22 22
Use of Device Problem 20 20
Defective Device 20 20
Product Quality Problem 18 18
Unintended System Motion 15 15
Contamination 15 15
Device Damaged by Another Device 15 15
Device Dislodged or Dislocated 14 14
Component Missing 14 14
Material Perforation 12 12
Positioning Problem 12 12
Material Fragmentation 11 11
Loose or Intermittent Connection 11 11
Device Issue 10 10
Tear, Rip or Hole in Device Packaging 10 10
Insufficient Information 10 10
Failure to Deflate 10 10
Packaging Problem 8 8
Device-Device Incompatibility 8 8
Sticking 8 8
Fluid Leak 8 8
Difficult or Delayed Positioning 7 7
Peeled/Delaminated 7 7
Patient-Device Incompatibility 7 7
Device Operates Differently Than Expected 7 7
Activation, Positioning or SeparationProblem 7 7
Bent 6 6
Device Expiration Issue 5 5
Contamination /Decontamination Problem 5 5
Device Handling Problem 5 5
Device Operational Issue 4 4
Material Twisted/Bent 4 4
Mechanical Jam 4 4
Crack 4 4
Mechanical Problem 4 4
Incorrect Measurement 3 3
Collapse 3 3
Defective Component 3 3
Retraction Problem 3 3
Material Too Rigid or Stiff 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Material Too Soft/Flexible 3 3
No Flow 2 2
Noise, Audible 2 2
Separation Problem 2 2
Device Packaging Compromised 2 2
Human Factors Issue 2 2
Material Protrusion/Extrusion 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Device Contamination with Body Fluid 2 2
Partial Blockage 2 2
Positioning Failure 2 2
Migration or Expulsion of Device 2 2
Occlusion Within Device 1 1
Device Abrasion From Instrument Or Another Object 1 1
Material Frayed 1 1
Radiation Leak 1 1
Air Leak 1 1
Filling Problem 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7471 7471
No Clinical Signs, Symptoms or Conditions 1550 1550
No Patient Involvement 671 671
No Known Impact Or Consequence To Patient 338 338
Vascular Dissection 110 110
Death 106 106
Insufficient Information 103 103
Device Embedded In Tissue or Plaque 97 97
Intimal Dissection 93 93
Myocardial Infarction 81 81
Foreign Body In Patient 59 59
Low Blood Pressure/ Hypotension 52 52
Occlusion 51 51
Perforation of Vessels 50 50
Perforation 45 45
Cardiac Arrest 44 44
Patient Problem/Medical Problem 44 44
Injury 40 40
Angina 35 35
Air Embolism 32 32
No Code Available 31 31
Obstruction/Occlusion 31 31
Chest Pain 30 30
Bradycardia 27 27
Arrhythmia 27 27
Ischemia 27 27
Non specific EKG/ECG Changes 25 25
Hematoma 22 22
Vessel Or Plaque, Device Embedded In 22 22
Unspecified Tissue Injury 19 19
No Information 18 18
Stenosis 17 17
Cardiogenic Shock 16 16
Thrombosis 16 16
High Blood Pressure/ Hypertension 14 14
Ventricular Fibrillation 14 14
Hemorrhage/Bleeding 12 12
Embolism 12 12
Stroke/CVA 11 11
Vasoconstriction 11 11
Cardiac Tamponade 11 11
Pericardial Effusion 11 11
Tachycardia 9 9
Pulmonary Edema 8 8
Thrombus 8 8
ST Segment Elevation 8 8
Pain 8 8
Embolism/Embolus 8 8
Thrombosis/Thrombus 6 6
Calcium Deposits/Calcification 6 6
Unspecified Infection 5 5
Blood Loss 5 5
Respiratory Failure 5 5
Dyspnea 4 4
Cardiac Enzyme Elevation 4 4
Shock 4 4
Ventricular Tachycardia 3 3
Heart Failure 3 3
Rupture 3 3
Extravasation 3 3
Cardiopulmonary Arrest 3 3
Atrial Fibrillation 2 2
Aneurysm 2 2
Hypersensitivity/Allergic reaction 2 2
Fistula 2 2
Discharge 2 2
Discomfort 2 2
Seizures 2 2
Tissue Damage 2 2
Renal Failure 2 2
Respiratory Distress 2 2
Cardiac Perforation 2 2
Chest Tightness/Pressure 2 2
Multiple Organ Failure 2 2
Restenosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Liver Failure 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Test Result 1 1
Valvular Stenosis 1 1
Pseudoaneurysm 1 1
Diminished Pulse Pressure 1 1
Cognitive Changes 1 1
Loss Of Pulse 1 1
Vascular System (Circulation), Impaired 1 1
Pneumonia 1 1
Reocclusion 1 1
Transient Ischemic Attack 1 1
Coma 1 1
Brain Injury 1 1
Gastritis 1 1
Intracranial Hemorrhage 1 1
Infiltration into Tissue 1 1
Fatigue 1 1
Fever 1 1
Electro-Mechanical Dissociation 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Atherosclerosis 1 1
Anaphylactic Shock 1 1
Anemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Feb-14-2020
2 Abbott Vascular I May-12-2017
3 Boston Scientific Corporation II Nov-26-2019
4 Medtronic Vascular Galway DBA Medtronic Ireland II Oct-11-2019
5 Medtronic Vascular Galway DBA Medtronic Ireland II Sep-20-2017
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