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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
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 2
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 4
ORBUSNEICH MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRIREME MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2576 2576
2017 2752 2752
2018 2225 2225
2019 2102 2102
2020 1974 1974
2021 1252 1252

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5909 5909
Difficult to Remove 1567 1567
Break 1371 1371
Failure to Advance 884 884
Deflation Problem 803 803
Improper or Incorrect Procedure or Method 760 760
Inflation Problem 731 731
Detachment Of Device Component 642 642
Material Separation 508 508
Difficult to Advance 453 453
Adverse Event Without Identified Device or Use Problem 437 437
Leak/Splash 364 364
Burst Container or Vessel 363 363
Physical Resistance 302 302
Detachment of Device or Device Component 239 239
Material Deformation 211 211
Kinked 205 205
Entrapment of Device 191 191
Difficult To Position 132 132
Deformation Due to Compressive Stress 105 105
Nonstandard Device 103 103
Fracture 87 87
Stretched 83 83
Device Damaged Prior to Use 73 73
Material Split, Cut or Torn 56 56
Material Integrity Problem 48 48
Failure to Fold 47 47
Device Markings/Labelling Problem 43 43
Off-Label Use 40 40
Folded 40 40
Hole In Material 39 39
Torn Material 38 38
Physical Property Issue 36 36
Difficult to Open or Remove Packaging Material 35 35
Device Contamination with Chemical or Other Material 35 35
Material Puncture/Hole 32 32
Difficult to Insert 31 31
Physical Resistance/Sticking 29 29
Unsealed Device Packaging 27 27
Defective Device 23 23
Component Missing 22 22
Device Damaged by Another Device 19 19
Use of Device Problem 18 18
Product Quality Problem 18 18
Material Perforation 16 16
Device Dislodged or Dislocated 15 15
Device Operates Differently Than Expected 15 15
Loose or Intermittent Connection 13 13
Unintended System Motion 13 13
Contamination 12 12
Positioning Problem 12 12
Insufficient Information 12 12
Material Fragmentation 12 12
Tear, Rip or Hole in Device Packaging 11 11
Device Issue 10 10
Packaging Problem 9 9
Fluid Leak 9 9
Sticking 9 9
Peeled/Delaminated 9 9
Bent 8 8
Activation, Positioning or SeparationProblem 8 8
Failure to Deflate 8 8
Contamination /Decontamination Problem 7 7
Device-Device Incompatibility 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Difficult or Delayed Positioning 6 6
Device Handling Problem 6 6
Device Expiration Issue 6 6
Crack 6 6
Mechanical Problem 5 5
Material Twisted/Bent 5 5
Device Operational Issue 4 4
Collapse 4 4
Retraction Problem 4 4
Material Too Rigid or Stiff 3 3
Migration or Expulsion of Device 3 3
Positioning Failure 3 3
Incorrect Measurement 3 3
Device Slipped 3 3
Patient-Device Incompatibility 3 3
Mechanical Jam 3 3
Device Packaging Compromised 3 3
Material Too Soft/Flexible 3 3
Partial Blockage 3 3
Defective Component 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Distortion 3 3
Device Contamination with Body Fluid 2 2
Inadequacy of Device Shape and/or Size 2 2
Occlusion Within Device 2 2
Noise, Audible 2 2
Material Protrusion/Extrusion 2 2
Human Factors Issue 2 2
Failure to Form Staple 2 2
Device Difficult to Setup or Prepare 2 2
Separation Problem 2 2
Shelf Life Exceeded 1 1
Failure to Deliver 1 1
Wire(s), breakage of 1 1
Device Abrasion From Instrument Or Another Object 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9541 9541
No Clinical Signs, Symptoms or Conditions 1129 1129
No Patient Involvement 933 933
No Known Impact Or Consequence To Patient 417 417
Intimal Dissection 133 133
Death 125 125
Device Embedded In Tissue or Plaque 111 111
Vascular Dissection 91 91
Insufficient Information 85 85
Foreign Body In Patient 65 65
Myocardial Infarction 63 63
Occlusion 60 60
Patient Problem/Medical Problem 57 57
Low Blood Pressure/ Hypotension 50 50
Perforation of Vessels 49 49
Cardiac Arrest 49 49
Perforation 46 46
Chest Pain 40 40
Injury 40 40
No Code Available 36 36
Obstruction/Occlusion 35 35
Angina 32 32
Air Embolism 31 31
Non specific EKG/ECG Changes 26 26
Vessel Or Plaque, Device Embedded In 25 25
Bradycardia 24 24
No Information 22 22
Unspecified Tissue Injury 19 19
Ischemia 18 18
Thrombosis 17 17
Cardiogenic Shock 16 16
Stenosis 16 16
Embolism 14 14
Cardiac Tamponade 13 13
ST Segment Elevation 12 12
Hematoma 12 12
Thrombus 11 11
Ventricular Fibrillation 11 11
Stroke/CVA 10 10
Vasoconstriction 10 10
Calcium Deposits/Calcification 10 10
Pericardial Effusion 10 10
Arrhythmia 9 9
Pain 8 8
Respiratory Failure 7 7
Cardiac Enzyme Elevation 6 6
Shock 5 5
Blood Loss 5 5
High Blood Pressure/ Hypertension 5 5
Hemorrhage/Bleeding 4 4
Unspecified Infection 3 3
Heart Failure 3 3
Atrial Tachycardia 3 3
Cardiopulmonary Arrest 3 3
Dyspnea 3 3
Extravasation 3 3
Rupture 3 3
Ventricular Tachycardia 3 3
Transient Ischemic Attack 2 2
Renal Failure 2 2
Discharge 2 2
Aneurysm 2 2
Embolism/Embolus 2 2
Thrombosis/Thrombus 2 2
Multiple Organ Failure 2 2
Discomfort 2 2
Chest Tightness/Pressure 2 2
Tachycardia 2 2
Tissue Damage 2 2
Pulmonary Edema 2 2
Respiratory Distress 2 2
Seizures 2 2
Nausea 2 2
Restenosis 2 2
Liver Failure 1 1
Diminished Pulse Pressure 1 1
Test Result 1 1
Valvular Stenosis 1 1
Reocclusion 1 1
Pneumonia 1 1
Cardiac Perforation 1 1
Loss Of Pulse 1 1
Vascular System (Circulation), Impaired 1 1
Brain Injury 1 1
Fistula 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Electro-Mechanical Dissociation 1 1
Atherosclerosis 1 1
Atrial Fibrillation 1 1
Exposure to Body Fluids 1 1
Syncope 1 1
Anaphylactic Shock 1 1
Anemia 1 1
Fatigue 1 1
Fever 1 1
Gastritis 1 1
Hypersensitivity/Allergic reaction 1 1
Infiltration into Tissue 1 1
Coma 1 1
Ischemic Heart Disease 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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