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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
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
  1.  K210230  Phenom Catheters
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 270 270

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3038 3038
Adverse Event Without Identified Device or Use Problem 2428 2491
Break 1194 1194
Material Deformation 1017 1017
Detachment of Device or Device Component 873 873
Physical Resistance/Sticking 811 811
Deformation Due to Compressive Stress 754 754
Material Separation 675 675
Leak/Splash 616 616
Material Twisted/Bent 512 512
Difficult to Remove 501 501
Fluid/Blood Leak 425 425
Fracture 415 415
Material Integrity Problem 361 361
Deflation Problem 348 348
Difficult to Advance 324 324
Unraveled Material 312 312
Material Split, Cut or Torn 298 298
Crack 296 296
Failure to Advance 246 246
Inflation Problem 229 229
Entrapment of Device 188 188
Burst Container or Vessel 172 172
Peeled/Delaminated 167 167
Material Frayed 149 149
Material Puncture/Hole 140 140
Obstruction of Flow 130 130
Retraction Problem 127 127
Insufficient Information 123 123
Accessory Incompatible 116 116
Difficult to Insert 104 104
Device Dislodged or Dislocated 102 102
Use of Device Problem 99 99
Incorrect, Inadequate or Imprecise Result or Readings 87 87
Device Damaged by Another Device 80 80
Packaging Problem 80 80
Air/Gas in Device 77 77
Stretched 75 75
Improper or Incorrect Procedure or Method 74 74
Mechanical Problem 73 73
Device-Device Incompatibility 70 70
No Apparent Adverse Event 57 57
Patient Device Interaction Problem 52 52
Device Contamination with Chemical or Other Material 52 52
Device Damaged Prior to Use 49 49
Failure to Deflate 46 46
Positioning Problem 45 45
Appropriate Term/Code Not Available 45 45
Unable to Obtain Readings 42 42
Gas/Air Leak 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8774 8774
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 735 735
Vascular Dissection 438 438
Foreign Body In Patient 424 424
Thrombosis/Thrombus 382 382
Pericardial Effusion 365 365
No Known Impact Or Consequence To Patient 257 257
Hemorrhage/Bleeding 249 312
Intracranial Hemorrhage 232 295
Hematoma 223 286
Low Blood Pressure/ Hypotension 218 218
Cardiac Perforation 186 186
Perforation of Vessels 179 179
Stroke/CVA 164 164
Cardiac Tamponade 164 164
Obstruction/Occlusion 144 144
Device Embedded In Tissue or Plaque 134 134
Vasoconstriction 130 130
Embolism/Embolus 122 122
Air Embolism 116 116
Perforation 105 105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 96 96
No Patient Involvement 93 93
Ischemia Stroke 93 93
Non specific EKG/ECG Changes 88 88
Rupture 82 82
Cardiac Arrest 77 77
Thromboembolism 76 76
Unspecified Nervous System Problem 74 74
Pseudoaneurysm 69 69
Swelling/ Edema 68 68
Ischemia 62 62
Pain 59 59
Myocardial Infarction 51 51
Stenosis 46 46
Bradycardia 45 45
Arrhythmia 44 44
Death 40 40
Ruptured Aneurysm 38 38
Unspecified Tissue Injury 38 38
No Code Available 34 34
Aneurysm 33 33
Transient Ischemic Attack 31 31
Injury 29 29
Unspecified Infection 28 28
No Information 27 27
Restenosis 26 26
High Blood Pressure/ Hypertension 25 25
Headache 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 MICROVENTION INC. II Jan-17-2025
12 MICROVENTION INC. III Jun-07-2021
13 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
14 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
15 Medtronic Vascular II Mar-11-2021
16 Merit Medical Systems, Inc. II Jan-02-2024
17 Mivi Neuroscience Inc II Sep-09-2021
18 ROUTE 92 MEDICAL INC I Apr-24-2024
19 Scientia Vascular, Inc. II Mar-13-2023
20 Stryker Neurovascular II May-28-2024
21 Stryker Neurovascular II May-01-2024
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