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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
  1.  K250558  SelectSite C304 Deflectable Catheter System (C304) ...
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K250558  SelectSite C304 Deflectable Catheter System (C304) ...
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
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
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 1137 1137

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3169 3169
Adverse Event Without Identified Device or Use Problem 2596 2659
Break 1256 1256
Material Deformation 1076 1076
Detachment of Device or Device Component 899 899
Physical Resistance/Sticking 848 848
Deformation Due to Compressive Stress 766 766
Material Separation 715 715
Leak/Splash 635 635
Material Twisted/Bent 557 557
Difficult to Remove 535 535
Fracture 450 450
Fluid/Blood Leak 445 445
Material Integrity Problem 388 388
Difficult to Advance 364 364
Deflation Problem 353 353
Unraveled Material 333 333
Material Split, Cut or Torn 326 326
Crack 312 312
Failure to Advance 251 251
Inflation Problem 234 234
Entrapment of Device 195 195
Burst Container or Vessel 181 181
Peeled/Delaminated 176 176
Material Frayed 156 156
Material Puncture/Hole 144 144
Insufficient Information 138 138
Obstruction of Flow 138 138
Accessory Incompatible 132 132
Retraction Problem 130 130
Difficult to Insert 115 115
Device Dislodged or Dislocated 109 109
Use of Device Problem 103 103
Incorrect, Inadequate or Imprecise Result or Readings 91 91
Device Damaged by Another Device 88 88
Packaging Problem 88 88
Mechanical Problem 85 85
Air/Gas in Device 79 79
Stretched 79 79
Improper or Incorrect Procedure or Method 78 78
Device-Device Incompatibility 71 71
No Apparent Adverse Event 58 58
Appropriate Term/Code Not Available 55 55
Patient Device Interaction Problem 55 55
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 48 48
Positioning Problem 46 46
Gas/Air Leak 42 42

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9363 9363
No Consequences Or Impact To Patient 1912 1912
Insufficient Information 782 782
Vascular Dissection 454 454
Foreign Body In Patient 448 448
Thrombosis/Thrombus 414 414
Pericardial Effusion 397 397
Hemorrhage/Bleeding 272 335
No Known Impact Or Consequence To Patient 257 257
Intracranial Hemorrhage 249 312
Hematoma 243 306
Low Blood Pressure/ Hypotension 243 243
Cardiac Perforation 206 206
Perforation of Vessels 194 194
Cardiac Tamponade 181 181
Stroke/CVA 174 174
Obstruction/Occlusion 155 155
Device Embedded In Tissue or Plaque 140 140
Vasoconstriction 138 138
Air Embolism 131 131
Embolism/Embolus 130 130
Perforation 114 114
Ischemia Stroke 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 106 106
Non specific EKG/ECG Changes 99 99
No Patient Involvement 93 93
Cardiac Arrest 83 83
Rupture 82 82
Thromboembolism 80 80
Unspecified Nervous System Problem 74 74
Pseudoaneurysm 73 73
Swelling/ Edema 71 71
Ischemia 66 66
Myocardial Infarction 59 59
Pain 58 58
Stenosis 51 51
Bradycardia 49 49
Arrhythmia 48 48
Ruptured Aneurysm 41 41
Death 40 40
Unspecified Tissue Injury 39 39
Aneurysm 34 34
No Code Available 34 34
Transient Ischemic Attack 33 33
Headache 30 30
Injury 29 29
Hemorrhagic Stroke 29 29
Muscle Weakness 28 28
Unspecified Infection 28 28
Heart Block 27 27

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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