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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ARRAVASC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTEGO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CREAGH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 6
KANEKA CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NATEC MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 3
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
O'CONNELL REGULATORY CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL COMPANY LIMITED (A COMPANY INCORPORATED IN HONG KONG)
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OSTIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K150946  FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH ...

MDR Year MDR Reports MDR Events
2015 1277 1277
2016 1526 1526
2017 2081 2081
2018 2188 2188
2019 2405 2405
2020 2448 2448

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 5905 5905
Balloon 4027 4027
Burst Container or Vessel 2135 2135
Leak/Splash 991 991
Difficult to Remove 658 658
Detachment of Device or Device Component 534 534
Deflation Problem 511 511
Adverse Event Without Identified Device or Use Problem 500 500
Inflation Problem 406 406
Catheter 392 392
Break 363 363
Detachment Of Device Component 300 300
Retraction Problem 239 239
Material Separation 213 213
Improper or Incorrect Procedure or Method 171 171
Material Deformation 165 165
Failure to Advance 152 152
Entrapment of Device 140 140
Shaft 124 124
Difficult to Advance 97 97
Material Puncture/Hole 68 68
Tip 64 64
Cutter/Blade 61 61
Material Frayed 61 61
Material Twisted/Bent 59 59
Hole In Material 53 53
Peeled/Delaminated 53 53
Difficult To Position 51 51
Physical Resistance 51 51
Device Handling Problem 51 51
Crack 49 49
Fluid Leak 48 48
Torn Material 47 47
Use of Device Problem 43 43
Device Dislodged or Dislocated 41 41
Kinked 40 40
Fracture 39 39
Defective Device 36 36
Off-Label Use 34 34
Packaging Problem 33 33
Device-Device Incompatibility 33 33
Difficult to Insert 30 30
Device Damaged by Another Device 30 30
Material Split, Cut or Torn 30 30
Device Markings/Labelling Problem 29 29
Unraveled Material 25 25
Folded 24 24
Device Contamination with Chemical or Other Material 23 23
Material Integrity Problem 23 23
Device Damaged Prior to Use 22 22
Structural Problem 22 22
Stretched 22 22
Device Operates Differently Than Expected 21 21
Component Missing 20 20
Material Fragmentation 15 15
Partial Blockage 14 14
Indicator 13 13
Sticking 13 13
Physical Resistance/Sticking 13 13
Hub 12 12
Device Expiration Issue 12 12
Insufficient Information 12 12
Unsealed Device Packaging 10 10
Bent 10 10
Failure to Fold 10 10
Physical Property Issue 9 9
Occlusion Within Device 8 8
Contamination /Decontamination Problem 8 8
Positioning Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Product Quality Problem 6 6
Device Fell 6 6
Deformation Due to Compressive Stress 6 6
Device Difficult to Setup or Prepare 6 6
Appropriate Term/Code Not Available 6 6
Device Packaging Compromised 5 5
Difficult to Open or Close 5 5
Wire 5 5
Defective Component 5 5
Loose or Intermittent Connection 4 4
Component Misassembled 4 4
Display 4 4
Difficult to Open or Remove Packaging Material 3 3
Shelf Life Exceeded 3 3
Obstruction of Flow 3 3
Migration 3 3
Delivered as Unsterile Product 3 3
Decrease in Pressure 3 3
Contamination 3 3
Pressure Problem 3 3
Scratched Material 2 2
Unintended Movement 2 2
Activation Failure 2 2
No Pressure 2 2
Fitting Problem 2 2
Connection Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Device Displays Incorrect Message 2 2
Difficult or Delayed Positioning 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9785 9786
No Known Impact Or Consequence To Patient 606 606
No Patient Involvement 367 367
Stenosis 161 161
Device Embedded In Tissue or Plaque 152 152
No Clinical Signs, Symptoms or Conditions 125 125
Patient Problem/Medical Problem 124 124
Occlusion 106 106
Foreign Body In Patient 90 90
No Code Available 88 88
Vascular Dissection 62 62
Injury 58 58
Death 49 49
Thrombus 43 43
Embolism 37 37
No Information 36 36
Reocclusion 33 33
Intimal Dissection 31 31
Hematoma 30 30
Perforation 26 26
Thrombosis 23 23
Vessel Or Plaque, Device Embedded In 22 22
Perforation of Vessels 22 22
Hemorrhage/Bleeding 19 19
Pain 15 15
Blood Loss 11 11
Calcium Deposits/Calcification 11 11
Ischemia 11 11
Rupture 11 11
Pseudoaneurysm 10 10
Great Vessel Perforation 10 10
Stroke/CVA 10 10
Needle Stick/Puncture 9 9
Vasoconstriction 8 8
Obstruction/Occlusion 7 7
Peripheral Vascular Disease 7 7
Tissue Damage 6 6
Unspecified Infection 6 6
Fistula 6 6
Myocardial Infarction 5 5
Not Applicable 5 5
Claudication 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Extravasation 5 5
Low Blood Pressure/ Hypotension 5 5
Inflammation 4 4
Fever 4 4
Thrombosis/Thrombus 4 4
Insufficient Information 4 4
Bradycardia 4 4
Arrhythmia 4 4
Pulmonary Edema 4 4
Atherosclerosis 3 3
Thromboembolism 3 3
Cardiac Arrest 3 3
Transient Ischemic Attack 3 3
Aneurysm 3 3
Muscle Spasm(s) 3 3
Swelling 2 2
Cardiac Tamponade 2 2
Failure of Implant 2 2
Infarction, Cerebral 2 2
Hemoptysis 2 2
Pneumonia 2 2
Pneumothorax 1 1
Seizures 1 1
Seroma 1 1
Tachycardia 1 1
Weakness 1 1
Unknown (for use when the patient's condition is not known) 1 1
Therapeutic Response, Decreased 1 1
Anxiety 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Internal Organ Perforation 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Abdominal Pain 1 1
Anaphylactic Shock 1 1
Reaction 1 1
Cardiac Perforation 1 1
Vascular System (Circulation), Impaired 1 1
Diminished Pulse Pressure 1 1
Test Result 1 1
Hydrocephalus 1 1
Swelling/ Edema 1 1
Hemorrhage, Cerebral 1 1
Hemorrhage, Intraventricular 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hyperthermia 1 1
Dyspnea 1 1
Pulmonary Embolism 1 1
Abortion 1 1
Abscess 1 1
Air Embolism 1 1
Physical Entrapment 1 1
Foreign body, removal of 1 1
Coma 1 1
Prolapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jan-30-2020
2 BrosMed Medical Co.,Ltd. II Feb-27-2019
3 Cordis Corporation II Feb-28-2020
4 Cordis Corporation II Oct-30-2019
5 Cordis Corporation II Nov-06-2018
6 Cordis Corporation II Jan-16-2015
7 EXP Pharmaceutical Services Corp II Jul-24-2015
8 Medtronic Inc II Dec-22-2016
9 Nucryo Vascular Inc. II Nov-21-2019
10 Us Endovascular II Apr-11-2016
11 ev3 Inc. II Sep-30-2020
12 ev3, Inc. II Apr-22-2016
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