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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 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 1808 1808
2024 1914 1914
2025 631 631

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8438 8438
Burst Container or Vessel 1968 1968
Leak/Splash 774 774
Difficult to Remove 764 764
Detachment of Device or Device Component 744 744
Adverse Event Without Identified Device or Use Problem 452 452
Break 448 448
Inflation Problem 370 370
Deflation Problem 370 370
Material Separation 322 322
Material Deformation 300 300
Difficult to Advance 216 216
Failure to Advance 177 177
Improper or Incorrect Procedure or Method 151 151
Entrapment of Device 139 139
Material Puncture/Hole 126 126
Material Split, Cut or Torn 125 125
Material Twisted/Bent 103 103
Device-Device Incompatibility 93 93
Retraction Problem 89 89
Fluid/Blood Leak 88 88
Fracture 87 87
Material Integrity Problem 84 84
Stretched 61 61
Material Frayed 54 54
Off-Label Use 52 52
Difficult to Insert 52 52
Use of Device Problem 48 48
Difficult to Open or Remove Packaging Material 43 43
Device Dislodged or Dislocated 43 43
Failure to Deflate 35 35
Partial Blockage 30 30
Device Handling Problem 28 28
Packaging Problem 27 27
Peeled/Delaminated 26 26
Device Contamination with Chemical or Other Material 26 26
Crack 25 25
Device Damaged Prior to Use 24 24
Device Markings/Labelling Problem 24 24
Failure to Fold 24 24
Device Damaged by Another Device 23 23
Structural Problem 22 22
Deformation Due to Compressive Stress 19 19
Physical Resistance/Sticking 16 16
Component Missing 14 14
Device Contaminated During Manufacture or Shipping 13 13
Defective Component 12 12
Unraveled Material 12 12
Material Fragmentation 12 12
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 8427 8427
No Consequences Or Impact To Patient 4150 4151
Foreign Body In Patient 193 193
Insufficient Information 190 190
Vascular Dissection 174 174
No Known Impact Or Consequence To Patient 141 141
No Patient Involvement 111 111
Device Embedded In Tissue or Plaque 92 92
Stenosis 84 84
Injury 54 54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Perforation of Vessels 53 53
No Code Available 50 50
Hematoma 50 50
Embolism/Embolus 49 49
Hemorrhage/Bleeding 48 48
Obstruction/Occlusion 41 41
Thrombosis/Thrombus 39 39
Patient Problem/Medical Problem 37 37
Restenosis 30 30
Pain 29 29
Unspecified Tissue Injury 22 22
Thrombus 20 20
Perforation 20 20
Death 18 18
Occlusion 17 17
Stroke/CVA 16 16
Pseudoaneurysm 15 15
Embolism 14 14
Unspecified Infection 13 13
Thrombosis 12 12
Fistula 11 11
Great Vessel Perforation 10 10
Reocclusion 10 10
Rupture 10 10
Extravasation 8 8
Vasoconstriction 8 8
Myocardial Infarction 8 8
Low Blood Pressure/ Hypotension 8 8
Arrhythmia 8 8
Swelling/ Edema 7 7
Calcium Deposits/Calcification 7 7
Blood Loss 6 6
Ischemia 6 6
Bradycardia 6 6
Aneurysm 6 6
Needle Stick/Puncture 6 6
No Information 6 6
Sepsis 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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