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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 9
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 3
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 7
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
  1.  K201811  coraForce and coraFlex Support Catheters
  2.  K233350  SINC Support Catheter
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K201811  coraForce and coraFlex Support Catheters
  2.  K233350  SINC Support Catheter
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
SHOCKWAVE MEDICAL, INC.
  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
W. L. GORE & ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3203 3203
2025 1385 1385

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3212 3212
Adverse Event Without Identified Device or Use Problem 2640 2703
Break 1265 1265
Material Deformation 1089 1089
Detachment of Device or Device Component 906 906
Physical Resistance/Sticking 854 854
Deformation Due to Compressive Stress 768 768
Material Separation 731 731
Leak/Splash 644 644
Material Twisted/Bent 575 575
Difficult to Remove 547 547
Fracture 459 459
Fluid/Blood Leak 454 454
Material Integrity Problem 395 395
Difficult to Advance 370 370
Deflation Problem 357 357
Unraveled Material 335 335
Material Split, Cut or Torn 333 333
Crack 313 313
Failure to Advance 252 252
Inflation Problem 237 237
Entrapment of Device 199 199
Burst Container or Vessel 181 181
Peeled/Delaminated 178 178
Material Frayed 157 157
Material Puncture/Hole 146 146
Obstruction of Flow 143 143
Insufficient Information 140 140
Accessory Incompatible 138 138
Retraction Problem 133 133
Difficult to Insert 118 118
Device Dislodged or Dislocated 112 112
Use of Device Problem 110 110
Incorrect, Inadequate or Imprecise Result or Readings 91 91
Packaging Problem 89 89
Device Damaged by Another Device 89 89
Mechanical Problem 87 87
Improper or Incorrect Procedure or Method 80 80
Stretched 79 79
Air/Gas in Device 79 79
Device-Device Incompatibility 76 76
Appropriate Term/Code Not Available 59 59
No Apparent Adverse Event 58 58
Patient Device Interaction Problem 56 56
Unable to Obtain Readings 54 54
Device Contamination with Chemical or Other Material 54 54
Device Damaged Prior to Use 49 49
Failure to Deflate 49 49
Positioning Problem 47 47
Material Fragmentation 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9539 9539
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 790 790
Vascular Dissection 458 458
Foreign Body In Patient 456 456
Thrombosis/Thrombus 423 423
Pericardial Effusion 406 406
Hemorrhage/Bleeding 279 342
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 252 315
Hematoma 251 314
Low Blood Pressure/ Hypotension 249 249
Cardiac Perforation 211 211
Perforation of Vessels 199 199
Cardiac Tamponade 187 187
Stroke/CVA 178 178
Obstruction/Occlusion 156 156
Device Embedded In Tissue or Plaque 142 142
Vasoconstriction 139 139
Air Embolism 136 136
Embolism/Embolus 132 132
Perforation 116 116
Ischemia Stroke 112 112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 108 108
Non specific EKG/ECG Changes 102 102
No Patient Involvement 93 93
Cardiac Arrest 86 86
Rupture 82 82
Thromboembolism 80 80
Unspecified Nervous System Problem 74 74
Pseudoaneurysm 73 73
Swelling/ Edema 71 71
Ischemia 66 66
Myocardial Infarction 60 60
Pain 59 59
Stenosis 51 51
Bradycardia 51 51
Arrhythmia 49 49
Ruptured Aneurysm 41 41
Death 40 40
Unspecified Tissue Injury 40 40
No Code Available 34 34
Aneurysm 34 34
Transient Ischemic Attack 33 33
Hemorrhagic Stroke 31 31
Headache 30 30
Injury 29 29
Heart Block 28 28
Unspecified Infection 28 28
High Blood Pressure/ Hypertension 28 28

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