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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 VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
CREAGH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. DBA SURMODICS, INC.
  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
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 2
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
QUALIMED USA, LLC.
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS
  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 1806 1806
2024 1914 1914
2025 144 144

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8164 8164
Burst Container or Vessel 1897 1897
Difficult to Remove 743 743
Leak/Splash 736 736
Detachment of Device or Device Component 711 711
Adverse Event Without Identified Device or Use Problem 437 437
Break 432 432
Deflation Problem 350 350
Inflation Problem 344 344
Material Separation 314 314
Material Deformation 280 280
Difficult to Advance 201 201
Failure to Advance 168 168
Improper or Incorrect Procedure or Method 145 145
Entrapment of Device 132 132
Material Puncture/Hole 122 122
Material Split, Cut or Torn 113 113
Material Twisted/Bent 98 98
Retraction Problem 89 89
Device-Device Incompatibility 88 88
Fluid/Blood Leak 86 86
Material Integrity Problem 81 81
Fracture 75 75
Off-Label Use 52 52
Material Frayed 51 51
Stretched 51 51
Difficult to Insert 49 49
Use of Device Problem 48 48
Device Dislodged or Dislocated 42 42
Difficult to Open or Remove Packaging Material 36 36
Failure to Deflate 33 33
Partial Blockage 30 30
Packaging Problem 27 27
Device Handling Problem 27 27
Device Contamination with Chemical or Other Material 26 26
Peeled/Delaminated 26 26
Device Damaged Prior to Use 24 24
Crack 24 24
Failure to Fold 24 24
Structural Problem 22 22
Device Markings/Labelling Problem 22 22
Device Damaged by Another Device 20 20
Deformation Due to Compressive Stress 19 19
Physical Resistance/Sticking 16 16
Component Missing 13 13
Device Contaminated During Manufacture or Shipping 13 13
Unraveled Material 12 12
Defective Component 12 12
Mechanical Jam 11 11
Tear, Rip or Hole in Device Packaging 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7969 7969
No Consequences Or Impact To Patient 4150 4151
Insufficient Information 184 184
Foreign Body In Patient 179 179
Vascular Dissection 165 165
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 111 111
Device Embedded In Tissue or Plaque 92 92
Stenosis 82 82
Injury 54 54
Perforation of Vessels 52 52
No Code Available 50 50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 49 49
Embolism/Embolus 48 48
Hematoma 47 47
Hemorrhage/Bleeding 45 45
Obstruction/Occlusion 40 40
Thrombosis/Thrombus 39 39
Patient Problem/Medical Problem 37 37
Pain 29 29
Restenosis 29 29
Unspecified Tissue Injury 22 22
Thrombus 20 20
Perforation 20 20
Death 18 18
Occlusion 17 17
Stroke/CVA 16 16
Embolism 14 14
Pseudoaneurysm 14 14
Unspecified Infection 13 13
Thrombosis 12 12
Fistula 11 11
Reocclusion 10 10
Rupture 10 10
Great Vessel Perforation 10 10
Extravasation 8 8
Low Blood Pressure/ Hypotension 8 8
Vasoconstriction 8 8
Myocardial Infarction 8 8
Arrhythmia 8 8
Calcium Deposits/Calcification 7 7
Swelling/ Edema 7 7
Blood Loss 6 6
Bradycardia 6 6
Ischemia 6 6
No Information 6 6
Needle Stick/Puncture 6 6
Sepsis 6 6
Aneurysm 6 6
Renal Failure 5 5

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 LP II Oct-29-2024
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 Jan-15-2025
11 ev3 Inc. II Sep-30-2020
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