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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
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 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 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 3204 3204
2025 546 546

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3072 3072
Adverse Event Without Identified Device or Use Problem 2477 2540
Break 1216 1216
Material Deformation 1034 1034
Detachment of Device or Device Component 883 883
Physical Resistance/Sticking 823 823
Deformation Due to Compressive Stress 758 758
Material Separation 692 692
Leak/Splash 619 619
Material Twisted/Bent 521 521
Difficult to Remove 510 510
Fluid/Blood Leak 431 431
Fracture 429 429
Material Integrity Problem 371 371
Deflation Problem 350 350
Difficult to Advance 340 340
Unraveled Material 319 319
Material Split, Cut or Torn 303 303
Crack 301 301
Failure to Advance 247 247
Inflation Problem 231 231
Entrapment of Device 190 190
Burst Container or Vessel 175 175
Peeled/Delaminated 170 170
Material Frayed 151 151
Material Puncture/Hole 141 141
Obstruction of Flow 135 135
Insufficient Information 132 132
Retraction Problem 128 128
Accessory Incompatible 124 124
Device Dislodged or Dislocated 105 105
Difficult to Insert 105 105
Use of Device Problem 100 100
Incorrect, Inadequate or Imprecise Result or Readings 89 89
Device Damaged by Another Device 83 83
Packaging Problem 82 82
Mechanical Problem 79 79
Air/Gas in Device 78 78
Stretched 76 76
Improper or Incorrect Procedure or Method 74 74
Device-Device Incompatibility 70 70
No Apparent Adverse Event 57 57
Device Contamination with Chemical or Other Material 54 54
Patient Device Interaction Problem 53 53
Appropriate Term/Code Not Available 52 52
Device Damaged Prior to Use 49 49
Failure to Deflate 47 47
Positioning Problem 46 46
Unable to Obtain Readings 46 46
Gas/Air Leak 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8954 8954
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 756 756
Vascular Dissection 441 441
Foreign Body In Patient 436 436
Thrombosis/Thrombus 390 390
Pericardial Effusion 372 372
No Known Impact Or Consequence To Patient 257 257
Hemorrhage/Bleeding 256 319
Intracranial Hemorrhage 233 296
Low Blood Pressure/ Hypotension 226 226
Hematoma 225 288
Cardiac Perforation 197 197
Perforation of Vessels 186 186
Cardiac Tamponade 169 169
Stroke/CVA 167 167
Obstruction/Occlusion 145 145
Device Embedded In Tissue or Plaque 136 136
Vasoconstriction 133 133
Embolism/Embolus 122 122
Air Embolism 119 119
Perforation 110 110
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Ischemia Stroke 96 96
No Patient Involvement 93 93
Non specific EKG/ECG Changes 92 92
Rupture 82 82
Thromboembolism 79 79
Cardiac Arrest 77 77
Unspecified Nervous System Problem 74 74
Pseudoaneurysm 72 72
Swelling/ Edema 68 68
Ischemia 65 65
Pain 57 57
Myocardial Infarction 55 55
Stenosis 46 46
Bradycardia 46 46
Arrhythmia 44 44
Death 40 40
Unspecified Tissue Injury 38 38
Ruptured Aneurysm 38 38
No Code Available 34 34
Aneurysm 33 33
Transient Ischemic Attack 32 32
Injury 29 29
Unspecified Infection 28 28
No Information 27 27
Restenosis 26 26
Heart Block 25 25
High Blood Pressure/ Hypertension 25 25

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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