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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
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC. (FORMERLY D.B.A. EV3 INC, COVIDIEN LLC.)
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALIMED USA, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2188 2188
2019 2405 2405
2020 2444 2444
2021 2492 2492
2022 2154 2154
2023 1265 1265

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 7723 7723
Burst Container or Vessel 2001 2001
Leak/Splash 734 734
Detachment of Device or Device Component 703 703
Difficult to Remove 666 666
Adverse Event Without Identified Device or Use Problem 443 443
Break 369 369
Inflation Problem 330 330
Deflation Problem 325 325
Material Separation 300 300
Material Deformation 235 235
Difficult to Advance 167 167
Failure to Advance 165 165
Retraction Problem 161 161
Improper or Incorrect Procedure or Method 158 158
Entrapment of Device 121 121
Material Puncture/Hole 101 101
Material Twisted/Bent 92 92
Device-Device Incompatibility 80 80
Fluid/Blood Leak 73 73
Material Split, Cut or Torn 72 72
Material Integrity Problem 68 68
Off-Label Use 60 60
Material Frayed 53 53
Fracture 52 52
Use of Device Problem 51 51
Device Dislodged or Dislocated 49 49
Difficult to Insert 47 47
Detachment Of Device Component 44 44
Peeled/Delaminated 44 44
Stretched 39 39
Device Handling Problem 38 38
Packaging Problem 32 32
Structural Problem 27 27
Partial Blockage 26 26
Crack 26 26
Device Markings/Labelling Problem 26 26
Device Damaged by Another Device 24 24
Failure to Deflate 24 24
Failure to Fold 21 21
Physical Resistance/Sticking 19 19
Device Contamination with Chemical or Other Material 18 18
Difficult to Open or Remove Packaging Material 17 17
Unraveled Material 17 17
Deformation Due to Compressive Stress 16 16
Device Damaged Prior to Use 14 14
Defective Component 13 13
Component Missing 13 13
Hole In Material 13 13
Device Contaminated During Manufacture or Shipping 13 13
Torn Material 11 11
Difficult To Position 11 11
Unsealed Device Packaging 11 11
Mechanical Jam 10 10
Difficult to Open or Close 10 10
Component Misassembled 9 9
Decrease in Pressure 9 9
Defective Device 8 8
Material Fragmentation 8 8
Kinked 8 8
Positioning Problem 8 8
Patient-Device Incompatibility 7 7
Contamination /Decontamination Problem 6 6
Accessory Incompatible 6 6
Tear, Rip or Hole in Device Packaging 6 6
Product Quality Problem 6 6
Difficult to Flush 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Migration 4 4
Migration or Expulsion of Device 4 4
Device Difficult to Setup or Prepare 4 4
Physical Resistance 4 4
Obstruction of Flow 3 3
Mechanical Problem 3 3
Occlusion Within Device 3 3
Flaked 3 3
Contamination 3 3
Separation Problem 3 3
Pressure Problem 3 3
Physical Property Issue 2 2
Component or Accessory Incompatibility 2 2
Compatibility Problem 2 2
Patient Device Interaction Problem 2 2
Sharp Edges 2 2
Device Fell 2 2
No Display/Image 2 2
Degraded 2 2
Difficult or Delayed Positioning 2 2
Incomplete or Missing Packaging 2 2
Folded 2 2
Expiration Date Error 2 2
Separation Failure 1 1
Device Or Device Fragments Location Unknown 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Wire(s), breakage of 1 1
Device Issue 1 1
Reflux within Device 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5969 5970
No Clinical Signs, Symptoms or Conditions 5549 5549
No Known Impact Or Consequence To Patient 254 254
No Patient Involvement 177 177
Insufficient Information 153 153
Foreign Body In Patient 147 147
Vascular Dissection 135 135
Stenosis 127 127
Device Embedded In Tissue or Plaque 122 122
Patient Problem/Medical Problem 66 66
No Code Available 65 65
Injury 57 57
Perforation of Vessels 49 49
Hematoma 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Hemorrhage/Bleeding 41 41
Embolism/Embolus 38 38
Occlusion 37 37
Obstruction/Occlusion 31 31
Thrombosis/Thrombus 28 28
Restenosis 28 28
Death 28 28
Thrombus 26 26
Pain 23 23
Unspecified Tissue Injury 21 21
Perforation 19 19
Stroke/CVA 16 16
Embolism 15 15
Thrombosis 15 15
Pseudoaneurysm 15 15
Reocclusion 14 14
No Information 12 12
Rupture 12 12
Great Vessel Perforation 10 10
Unspecified Infection 9 9
Needle Stick/Puncture 9 9
Low Blood Pressure/ Hypotension 8 8
Calcium Deposits/Calcification 8 8
Intimal Dissection 8 8
Arrhythmia 8 8
Vessel Or Plaque, Device Embedded In 7 7
Aneurysm 7 7
Fistula 7 7
Myocardial Infarction 7 7
Blood Loss 7 7
Ischemia 6 6
Cardiac Arrest 6 6
Bradycardia 5 5
High Blood Pressure/ Hypertension 5 5
Renal Failure 5 5
Not Applicable 5 5
Thromboembolism 4 4
Transient Ischemic Attack 4 4
Vasoconstriction 4 4
Pulmonary Edema 4 4
Necrosis 3 3
Vomiting 3 3
Failure of Implant 3 3
Extravasation 3 3
Fever 3 3
Claudication 3 3
Swelling/ Edema 3 3
Arteriosclerosis/ Atherosclerosis 2 2
Numbness 2 2
Cardiac Perforation 2 2
Prolapse 2 2
Post Operative Wound Infection 2 2
Diarrhea 2 2
Infarction, Cerebral 2 2
Pulmonary Embolism 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Hemoptysis 2 2
Tissue Damage 2 2
Inflammation 2 2
Tachycardia 2 2
Nausea 2 2
Pneumonia 2 2
Sepsis 2 2
Seroma 1 1
Skin Irritation 1 1
Swelling 1 1
Rash 1 1
Internal Organ Perforation 1 1
Pneumothorax 1 1
Neuropathy 1 1
Seizures 1 1
Ventricular Fibrillation 1 1
Physical Entrapment 1 1
Anxiety 1 1
Discomfort 1 1
Hemorrhage, Cerebral 1 1
Infiltration into Tissue 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Mitral Valve Stenosis 1 1
Muscle Spasm(s) 1 1
Air Embolism 1 1
Anaphylactic Shock 1 1
Bruise/Contusion 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 Aug-09-2021
4 Cordis Corporation II Feb-28-2020
5 Cordis Corporation II Oct-30-2019
6 Cordis Corporation II Nov-06-2018
7 Covidien Llc II Feb-03-2022
8 Nucryo Vascular Inc. II Nov-21-2019
9 Ostial Corporation II Aug-17-2021
10 ev3 Inc. II Sep-30-2020
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