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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
CONTEGO MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211044  Sublime Radial Access 018 RX Dilatation Catheter
CREAGH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211044  Sublime Radial Access 018 RX Dilatation Catheter
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211044  Sublime Radial Access 018 RX Dilatation Catheter
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO.,LTD.
  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
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
2019 2405 2405
2020 2443 2443
2021 2492 2492
2022 2155 2155
2023 1803 1803
2024 416 416

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 7227 7227
Burst Container or Vessel 1685 1685
Difficult to Remove 636 636
Detachment of Device or Device Component 629 629
Leak/Splash 614 614
Break 366 366
Adverse Event Without Identified Device or Use Problem 362 362
Inflation Problem 280 280
Deflation Problem 277 277
Material Separation 268 268
Material Deformation 230 230
Difficult to Advance 161 161
Failure to Advance 145 145
Improper or Incorrect Procedure or Method 129 129
Entrapment of Device 118 118
Material Puncture/Hole 103 103
Retraction Problem 89 89
Material Twisted/Bent 88 88
Device-Device Incompatibility 82 82
Material Split, Cut or Torn 78 78
Material Integrity Problem 73 73
Fluid/Blood Leak 71 71
Fracture 58 58
Off-Label Use 48 48
Difficult to Insert 46 46
Use of Device Problem 45 45
Stretched 43 43
Device Dislodged or Dislocated 40 40
Material Frayed 38 38
Partial Blockage 28 28
Device Handling Problem 27 27
Failure to Deflate 27 27
Difficult to Open or Remove Packaging Material 27 27
Peeled/Delaminated 26 26
Failure to Fold 23 23
Structural Problem 21 21
Packaging Problem 21 21
Crack 20 20
Device Contamination with Chemical or Other Material 20 20
Device Damaged by Another Device 20 20
Device Damaged Prior to Use 17 17
Device Markings/Labelling Problem 16 16
Physical Resistance/Sticking 16 16
Device Contaminated During Manufacture or Shipping 13 13
Deformation Due to Compressive Stress 13 13
Unraveled Material 12 12
Defective Component 12 12
Component Missing 11 11
Mechanical Jam 10 10
Decrease in Pressure 9 9
Defective Device 9 9
Difficult to Open or Close 9 9
Component Misassembled 9 9
Positioning Problem 8 8
Material Fragmentation 8 8
Patient-Device Incompatibility 7 7
Tear, Rip or Hole in Device Packaging 6 6
Contamination /Decontamination Problem 6 6
Difficult to Flush 6 6
Accessory Incompatible 6 6
Suction Problem 4 4
Appropriate Term/Code Not Available 4 4
Product Quality Problem 4 4
Migration 4 4
Migration or Expulsion of Device 4 4
Device Difficult to Setup or Prepare 3 3
Delivered as Unsterile Product 3 3
Unsealed Device Packaging 3 3
Flaked 3 3
Separation Problem 3 3
Mechanical Problem 3 3
Incomplete or Missing Packaging 2 2
Component or Accessory Incompatibility 2 2
Patient Device Interaction Problem 2 2
Difficult or Delayed Positioning 2 2
No Display/Image 2 2
Degraded 2 2
Obstruction of Flow 2 2
Expiration Date Error 2 2
Compatibility Problem 2 2
Contamination 2 2
Device Fell 2 2
Material Discolored 1 1
Activation, Positioning or Separation Problem 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Explosion 1 1
Poor Visibility 1 1
Separation Failure 1 1
Material Too Rigid or Stiff 1 1
Complete Blockage 1 1
Unintended Movement 1 1
Pressure Problem 1 1
Air/Gas in Device 1 1
Difficult to Fold, Unfold or Collapse 1 1
Failure to Back-Up 1 1
Material Too Soft/Flexible 1 1
Failure to Unfold or Unwrap 1 1
Insufficient Information 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6451 6451
No Consequences Or Impact To Patient 4150 4151
Insufficient Information 158 158
No Known Impact Or Consequence To Patient 141 141
Foreign Body In Patient 138 138
Vascular Dissection 137 137
No Patient Involvement 111 111
Device Embedded In Tissue or Plaque 89 89
Stenosis 74 74
Injury 54 54
No Code Available 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Perforation of Vessels 46 46
Embolism/Embolus 41 41
Hematoma 41 41
Hemorrhage/Bleeding 40 40
Patient Problem/Medical Problem 37 37
Thrombosis/Thrombus 34 34
Obstruction/Occlusion 33 33
Restenosis 29 29
Pain 25 25
Unspecified Tissue Injury 21 21
Thrombus 20 20
Perforation 18 18
Death 18 18
Occlusion 17 17
Stroke/CVA 15 15
Pseudoaneurysm 14 14
Embolism 14 14
Thrombosis 12 12
Reocclusion 10 10
Great Vessel Perforation 10 10
Unspecified Infection 9 9
Rupture 9 9
Myocardial Infarction 8 8
Low Blood Pressure/ Hypotension 8 8
Arrhythmia 8 8
Calcium Deposits/Calcification 7 7
Fistula 7 7
Blood Loss 6 6
Needle Stick/Puncture 6 6
Aneurysm 6 6
No Information 6 6
Swelling/ Edema 5 5
Intimal Dissection 5 5
Renal Failure 5 5
Vasoconstriction 5 5
Vessel Or Plaque, Device Embedded In 5 5
Bradycardia 5 5
Ischemia 4 4
Extravasation 4 4
High Blood Pressure/ Hypertension 4 4
Cardiac Arrest 4 4
Transient Ischemic Attack 4 4
Thromboembolism 4 4
Necrosis 3 3
Vomiting 3 3
Fever 3 3
Failure of Implant 3 3
Sepsis 2 2
Post Operative Wound Infection 2 2
Cardiac Perforation 2 2
Tachycardia 2 2
Nausea 2 2
Inflammation 2 2
Pulmonary Embolism 2 2
Numbness 2 2
Arteriosclerosis/ Atherosclerosis 2 2
Diarrhea 2 2
Pneumonia 2 2
Infarction, Cerebral 2 2
Pulmonary Edema 2 2
Hypoxia 2 2
Prolapse 2 2
Hypersensitivity/Allergic reaction 2 2
Atrial Perforation 1 1
Dyspnea 1 1
Ecchymosis 1 1
Bruise/Contusion 1 1
Cardiovascular Insufficiency 1 1
Seroma 1 1
Anaphylactic Shock 1 1
Discomfort 1 1
Pneumothorax 1 1
Itching Sensation 1 1
Ventricular Fibrillation 1 1
Cardiogenic Shock 1 1
Neuropathy 1 1
Unspecified Vascular Problem 1 1
Rash 1 1
Skin Irritation 1 1
Swelling 1 1
Physical Entrapment 1 1
Hemorrhage, Cerebral 1 1
Internal Organ Perforation 1 1
Cellulitis 1 1
Asystole 1 1
Laceration(s) 1 1
Ruptured Aneurysm 1 1
Hemorrhagic Stroke 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 Covidien Llc II Feb-03-2022
7 Nucryo Vascular Inc. II Nov-21-2019
8 Ostial Corporation II Aug-17-2021
9 ev3 Inc. II Sep-30-2020
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