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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous
Regulation Description Percutaneous catheter.
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 2
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BASIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K212228  WATCHMAN FXD Curve Access System
  2.  K223633  Rubicon™ Control Support Catheter (H749394323506A1 ...
  3.  K240018  WATCHMAN TruSteer Access System (M635TU90050)
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  1.  K212228  WATCHMAN FXD Curve Access System
  2.  K223633  Rubicon™ Control Support Catheter (H749394323506A1 ...
  3.  K240018  WATCHMAN TruSteer Access System (M635TU90050)
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 3
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 VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEIGLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIMPSON INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS. INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  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
VANTIS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 4
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2889 2889
2021 3009 3009
2022 2646 2646
2023 3062 3125
2024 3202 3202
2025 811 811

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3119 3119
Adverse Event Without Identified Device or Use Problem 2531 2594
Break 1235 1235
Material Deformation 1049 1049
Detachment of Device or Device Component 889 889
Physical Resistance/Sticking 829 829
Deformation Due to Compressive Stress 762 762
Material Separation 700 700
Leak/Splash 625 625
Material Twisted/Bent 539 539
Difficult to Remove 518 518
Fluid/Blood Leak 438 438
Fracture 436 436
Material Integrity Problem 379 379
Difficult to Advance 356 356
Deflation Problem 351 351
Unraveled Material 323 323
Material Split, Cut or Torn 313 313
Crack 303 303
Failure to Advance 249 249
Inflation Problem 231 231
Entrapment of Device 193 193
Burst Container or Vessel 177 177
Peeled/Delaminated 173 173
Material Frayed 152 152
Material Puncture/Hole 142 142
Obstruction of Flow 138 138
Insufficient Information 135 135
Accessory Incompatible 130 130
Retraction Problem 130 130
Difficult to Insert 108 108
Device Dislodged or Dislocated 105 105
Use of Device Problem 102 102
Incorrect, Inadequate or Imprecise Result or Readings 89 89
Device Damaged by Another Device 87 87
Packaging Problem 85 85
Mechanical Problem 81 81
Air/Gas in Device 78 78
Stretched 76 76
Improper or Incorrect Procedure or Method 75 75
Device-Device Incompatibility 70 70
No Apparent Adverse Event 57 57
Device Contamination with Chemical or Other Material 54 54
Unable to Obtain Readings 54 54
Patient Device Interaction Problem 54 54
Appropriate Term/Code Not Available 54 54
Device Damaged Prior to Use 49 49
Failure to Deflate 48 48
Positioning Problem 46 46
Gas/Air Leak 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9147 9147
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 764 764
Vascular Dissection 448 448
Foreign Body In Patient 438 438
Thrombosis/Thrombus 400 400
Pericardial Effusion 384 384
Hemorrhage/Bleeding 266 329
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 240 303
Low Blood Pressure/ Hypotension 236 236
Hematoma 235 298
Cardiac Perforation 201 201
Perforation of Vessels 188 188
Cardiac Tamponade 174 174
Stroke/CVA 169 169
Obstruction/Occlusion 150 150
Device Embedded In Tissue or Plaque 137 137
Vasoconstriction 136 136
Embolism/Embolus 126 126
Air Embolism 123 123
Perforation 113 113
Ischemia Stroke 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Non specific EKG/ECG Changes 96 96
No Patient Involvement 93 93
Rupture 82 82
Thromboembolism 80 80
Cardiac Arrest 79 79
Unspecified Nervous System Problem 74 74
Pseudoaneurysm 73 73
Swelling/ Edema 70 70
Ischemia 66 66
Pain 58 58
Myocardial Infarction 56 56
Stenosis 50 50
Arrhythmia 48 48
Bradycardia 47 47
Death 40 40
Ruptured Aneurysm 40 40
Unspecified Tissue Injury 38 38
No Code Available 34 34
Aneurysm 33 33
Transient Ischemic Attack 33 33
Injury 29 29
Headache 29 29
Unspecified Infection 28 28
Muscle Weakness 27 27
No Information 27 27
Restenosis 26 26

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 Bard Peripheral Vascular Inc II Oct-08-2020
5 Boston Scientific Corporation II Oct-03-2023
6 Boston Scientific Corporation II Aug-25-2022
7 Boston Scientific Corporation II Apr-15-2021
8 Boston Scientific Corporation II Jan-15-2021
9 Cook Inc. II Jun-02-2020
10 Cook Incorporated II Jul-08-2022
11 Cordis US Corp II Mar-13-2025
12 MICROVENTION INC. II Jan-17-2025
13 MICROVENTION INC. III Jun-07-2021
14 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
15 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
16 Medtronic Vascular II Mar-11-2021
17 Merit Medical Systems, Inc. II Jan-02-2024
18 Mivi Neuroscience Inc II Sep-09-2021
19 ROUTE 92 MEDICAL INC I Apr-24-2024
20 Scientia Vascular, Inc. II Mar-13-2023
21 Stryker Neurovascular II May-28-2024
22 Stryker Neurovascular II May-01-2024
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