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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT (ST. JUDE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BALT USA LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERPOINT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 2
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CORDIS US CORP.
  SUBSTANTIALLY EQUIVALENT 1
CRUZAR MEDSYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
EOSOLUTIONS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEXACATH
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 6
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO INC.
  SUBSTANTIALLY EQUIVALENT 1
MARVAO MEDICAL DEVICES LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, LNC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICRO VENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROVENTION, INC., A TERUMO GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEIGLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS. INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRACTUS VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
TRAVERSE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRISALUS LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 5
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2902 2902
2020 2889 2889
2021 3009 3009
2022 2646 2646
2023 3072 3135
2024 2176 2176

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3329 3329
Adverse Event Without Identified Device or Use Problem 2475 2538
Break 1426 1426
Material Deformation 1408 1408
Detachment of Device or Device Component 1044 1044
Physical Resistance/Sticking 935 935
Leak/Splash 735 735
Deformation Due to Compressive Stress 731 731
Material Separation 694 694
Difficult to Remove 524 524
Fluid/Blood Leak 447 447
Material Twisted/Bent 428 428
Fracture 423 423
Material Integrity Problem 404 404
Deflation Problem 382 382
Failure to Advance 380 380
Difficult to Advance 357 357
Unraveled Material 354 354
Crack 332 332
Material Split, Cut or Torn 300 300
Inflation Problem 236 236
Entrapment of Device 221 221
Peeled/Delaminated 199 199
Burst Container or Vessel 197 197
Retraction Problem 182 182
Device Damaged Prior to Use 168 168
Material Frayed 162 162
Material Puncture/Hole 154 154
Insufficient Information 146 146
Obstruction of Flow 127 127
Difficult to Insert 125 125
Accessory Incompatible 113 113
Use of Device Problem 110 110
Device Dislodged or Dislocated 108 108
Device Damaged by Another Device 106 106
Packaging Problem 79 79
Device-Device Incompatibility 77 77
Improper or Incorrect Procedure or Method 76 76
Complete Blockage 76 76
Stretched 71 71
Incorrect, Inadequate or Imprecise Result or Readings 70 70
Air/Gas in Device 69 69
Mechanical Problem 68 68
Material Fragmentation 61 61
Gas/Air Leak 60 60
No Apparent Adverse Event 60 60
Device Contamination with Chemical or Other Material 56 56
Patient Device Interaction Problem 50 50
Appropriate Term/Code Not Available 46 46
Unsealed Device Packaging 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7882 7882
No Consequences Or Impact To Patient 3671 3671
No Known Impact Or Consequence To Patient 766 766
Insufficient Information 653 653
Vascular Dissection 474 474
Foreign Body In Patient 400 400
Pericardial Effusion 336 336
Thrombosis/Thrombus 333 333
No Patient Involvement 299 299
Hemorrhage/Bleeding 238 301
Hematoma 220 283
Intracranial Hemorrhage 219 282
Low Blood Pressure/ Hypotension 208 208
Device Embedded In Tissue or Plaque 202 202
Perforation of Vessels 182 182
Cardiac Perforation 174 174
Stroke/CVA 161 161
Cardiac Tamponade 149 149
Obstruction/Occlusion 133 133
Vasoconstriction 130 130
Perforation 120 120
Embolism/Embolus 113 113
Air Embolism 107 107
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 93 93
Rupture 92 92
Death 76 76
No Information 75 75
Ischemia Stroke 74 74
No Code Available 73 73
Cardiac Arrest 72 72
Thromboembolism 71 71
Pseudoaneurysm 70 70
Non specific EKG/ECG Changes 69 69
Unspecified Nervous System Problem 69 69
Swelling/ Edema 66 66
Ischemia 60 60
Pain 53 53
Myocardial Infarction 52 52
Injury 50 50
Stenosis 49 49
Embolism 42 42
Bradycardia 40 40
Aneurysm 39 39
Unspecified Tissue Injury 38 38
Ruptured Aneurysm 37 37
Arrhythmia 37 37
Thrombosis 34 34
Unspecified Infection 34 34
Transient Ischemic Attack 30 30
Vessel Or Plaque, Device Embedded In 29 29

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I Jul-11-2023
2 Abbott II Apr-07-2022
3 Arrow International Inc II Feb-14-2020
4 Arrow International Inc II Apr-10-2019
5 Arrow International Inc II Jan-11-2019
6 Bard Peripheral Vascular Inc II Oct-08-2020
7 Boston Scientific Corporation II Oct-03-2023
8 Boston Scientific Corporation II Aug-25-2022
9 Boston Scientific Corporation II Apr-15-2021
10 Boston Scientific Corporation II Jan-15-2021
11 Boston Scientific Corporation II Nov-26-2019
12 Cook Inc. II Jun-02-2020
13 Cook Incorporated II Jul-08-2022
14 Cordis Corporation III Apr-18-2019
15 MICROVENTION INC. III Jun-07-2021
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
18 Medtronic Vascular II Mar-11-2021
19 Medtronic Vascular I Oct-01-2019
20 Merit Medical Systems, Inc. II Jan-02-2024
21 Mivi Neuroscience Inc II Sep-09-2021
22 ROUTE 92 MEDICAL INC I Apr-24-2024
23 Scientia Vascular, Inc. II Mar-13-2023
24 Stryker Neurovascular II May-28-2024
25 Stryker Neurovascular II May-01-2024
26 Stryker Neurovascular II Oct-08-2019
27 Stryker Neurovascular II Jun-02-2019
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