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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 2
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
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
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 1
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 3063 3126
2024 3206 3206

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3000 3000
Adverse Event Without Identified Device or Use Problem 2388 2451
Break 1161 1161
Material Deformation 1003 1003
Detachment of Device or Device Component 861 861
Physical Resistance/Sticking 791 791
Deformation Due to Compressive Stress 731 731
Material Separation 659 659
Leak/Splash 609 609
Material Twisted/Bent 494 494
Difficult to Remove 492 492
Fluid/Blood Leak 419 419
Fracture 402 402
Material Integrity Problem 353 353
Deflation Problem 342 342
Difficult to Advance 319 319
Unraveled Material 307 307
Material Split, Cut or Torn 292 292
Crack 291 291
Failure to Advance 243 243
Inflation Problem 228 228
Entrapment of Device 186 186
Burst Container or Vessel 170 170
Peeled/Delaminated 160 160
Material Frayed 148 148
Material Puncture/Hole 139 139
Obstruction of Flow 127 127
Retraction Problem 127 127
Insufficient Information 116 116
Accessory Incompatible 113 113
Difficult to Insert 101 101
Device Dislodged or Dislocated 101 101
Use of Device Problem 98 98
Incorrect, Inadequate or Imprecise Result or Readings 87 87
Device Damaged by Another Device 79 79
Packaging Problem 79 79
Air/Gas in Device 76 76
Improper or Incorrect Procedure or Method 72 72
Stretched 72 72
Device-Device Incompatibility 70 70
Mechanical Problem 69 69
No Apparent Adverse Event 57 57
Device Contamination with Chemical or Other Material 52 52
Patient Device Interaction Problem 50 50
Device Damaged Prior to Use 49 49
Failure to Deflate 45 45
Appropriate Term/Code Not Available 42 42
Positioning Problem 42 42
Gas/Air Leak 40 40
Unsealed Device Packaging 40 40

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8586 8586
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 717 717
Vascular Dissection 428 428
Foreign Body In Patient 413 413
Thrombosis/Thrombus 370 370
Pericardial Effusion 357 357
No Known Impact Or Consequence To Patient 257 257
Hemorrhage/Bleeding 247 310
Intracranial Hemorrhage 227 290
Hematoma 222 285
Low Blood Pressure/ Hypotension 215 215
Cardiac Perforation 179 179
Perforation of Vessels 172 172
Stroke/CVA 161 161
Cardiac Tamponade 157 157
Obstruction/Occlusion 143 143
Device Embedded In Tissue or Plaque 133 133
Vasoconstriction 129 129
Embolism/Embolus 120 120
Air Embolism 114 114
Perforation 106 106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 95 95
No Patient Involvement 93 93
Non specific EKG/ECG Changes 86 86
Ischemia Stroke 85 85
Rupture 81 81
Cardiac Arrest 75 75
Thromboembolism 75 75
Unspecified Nervous System Problem 70 70
Swelling/ Edema 68 68
Pseudoaneurysm 68 68
Ischemia 60 60
Pain 56 56
Myocardial Infarction 47 47
Stenosis 46 46
Bradycardia 44 44
Arrhythmia 41 41
Death 40 40
Ruptured Aneurysm 38 38
Unspecified Tissue Injury 38 38
No Code Available 34 34
Aneurysm 33 33
Transient Ischemic Attack 30 30
Injury 29 29
Unspecified Infection 28 28
No Information 27 27
Restenosis 26 26
High Blood Pressure/ Hypertension 25 25
Extravasation 23 23

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 MICROVENTION INC. III Jun-07-2021
12 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
13 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
14 Medtronic Vascular II Mar-11-2021
15 Merit Medical Systems, Inc. II Jan-02-2024
16 Mivi Neuroscience Inc II Sep-09-2021
17 ROUTE 92 MEDICAL INC I Apr-24-2024
18 Scientia Vascular, Inc. II Mar-13-2023
19 Stryker Neurovascular II May-28-2024
20 Stryker Neurovascular II May-01-2024
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