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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
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN INTERVENTIONAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 3
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIL LIFE SCIENCES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
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 532 532

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5524 5524
Difficult to Remove 1452 1452
Break 1289 1289
Failure to Advance 823 823
Deflation Problem 774 774
Improper or Incorrect Procedure or Method 724 724
Inflation Problem 709 709
Detachment Of Device Component 642 642
Material Separation 460 460
Adverse Event Without Identified Device or Use Problem 407 407
Difficult to Advance 376 376
Leak/Splash 352 352
Burst Container or Vessel 340 340
Physical Resistance 302 302
Detachment of Device or Device Component 221 221
Kinked 205 205
Material Deformation 186 186
Entrapment of Device 182 182
Difficult To Position 132 132
Nonstandard Device 103 103
Deformation Due to Compressive Stress 91 91
Stretched 82 82
Fracture 79 79
Device Damaged Prior to Use 73 73
Material Split, Cut or Torn 49 49
Device Markings/Labelling Problem 42 42
Material Integrity Problem 41 41
Failure to Fold 40 40
Folded 40 40
Hole In Material 39 39
Torn Material 38 38
Physical Property Issue 36 36
Off-Label Use 35 35
Device Contamination with Chemical or Other Material 35 35
Difficult to Open or Remove Packaging Material 34 34
Material Puncture/Hole 32 32
Difficult to Insert 29 29
Physical Resistance/Sticking 28 28
Unsealed Device Packaging 24 24
Defective Device 22 22
Component Missing 20 20
Device Damaged by Another Device 19 19
Use of Device Problem 18 18
Product Quality Problem 17 17
Material Perforation 16 16
Device Operates Differently Than Expected 15 15
Device Dislodged or Dislocated 14 14
Loose or Intermittent Connection 13 13
Unintended System Motion 12 12
Positioning Problem 12 12
Tear, Rip or Hole in Device Packaging 11 11
Insufficient Information 11 11
Material Fragmentation 11 11
Device Issue 10 10
Contamination 10 10
Peeled/Delaminated 9 9
Sticking 9 9
Fluid Leak 9 9
Bent 8 8
Packaging Problem 8 8
Activation, Positioning or SeparationProblem 7 7
Device-Device Incompatibility 7 7
Contamination /Decontamination Problem 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 Misassembled During Manufacturing /Shipping 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
Device Contaminated During Manufacture or Shipping 3 3
Material Distortion 3 3
Partial Blockage 3 3
Defective Component 3 3
Device Contamination with Body Fluid 2 2
Inadequacy of Device Shape and/or Size 2 2
Occlusion Within Device 2 2
Material Protrusion/Extrusion 2 2
Noise, Audible 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
Failure to Deflate 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 Patient Involvement 933 933
No Clinical Signs, Symptoms or Conditions 483 483
No Known Impact Or Consequence To Patient 417 417
Intimal Dissection 133 133
Death 125 125
Device Embedded In Tissue or Plaque 108 108
Vascular Dissection 83 83
Insufficient Information 63 63
Occlusion 60 60
Patient Problem/Medical Problem 57 57
Foreign Body In Patient 56 56
Myocardial Infarction 56 56
Low Blood Pressure/ Hypotension 49 49
Cardiac Arrest 48 48
Perforation of Vessels 43 43
Perforation 41 41
Injury 40 40
Chest Pain 37 37
No Code Available 36 36
Angina 31 31
Air Embolism 30 30
Obstruction/Occlusion 29 29
Vessel Or Plaque, Device Embedded In 25 25
Bradycardia 24 24
Non specific EKG/ECG Changes 23 23
No Information 22 22
Thrombosis 17 17
Ischemia 16 16
Cardiogenic Shock 16 16
Stenosis 16 16
Embolism 14 14
Cardiac Tamponade 13 13
ST Segment Elevation 12 12
Thrombus 11 11
Hematoma 11 11
Ventricular Fibrillation 11 11
Stroke/CVA 10 10
Calcium Deposits/Calcification 10 10
Vasoconstriction 8 8
Arrhythmia 8 8
Pain 7 7
Respiratory Failure 7 7
Pericardial Effusion 7 7
Cardiac Enzyme Elevation 6 6
Unspecified Tissue Injury 6 6
Blood Loss 5 5
Shock 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
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
Dyspnea 2 2
Multiple Organ Failure 2 2
Thrombosis/Thrombus 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
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
Diminished Pulse Pressure 1 1
Test Result 1 1
Valvular Stenosis 1 1
Restenosis 1 1
Liver Failure 1 1
Embolism/Embolus 1 1
Hypersensitivity/Allergic reaction 1 1
Infiltration into Tissue 1 1
Anemia 1 1
Fever 1 1
Gastritis 1 1
Coma 1 1
Ischemic Heart Disease 1 1
Low Cardiac Output 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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