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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 4
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BALT USA LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CENTERPOINT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 2
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
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 INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
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
MICRO VENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROVENTION, INC., A TERUMO GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 1
OKAMI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
QXMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEIGLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
SURMODICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS. INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRACTUS VASCULAR LLC
  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
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VANTIS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 5
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2902 2902
2020 2889 2889
2021 3009 3009
2022 2646 2646
2023 3064 3127
2024 2439 2439

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3381 3381
Adverse Event Without Identified Device or Use Problem 2516 2579
Break 1432 1432
Material Deformation 1411 1411
Detachment of Device or Device Component 1048 1048
Physical Resistance/Sticking 949 949
Leak/Splash 751 751
Deformation Due to Compressive Stress 732 732
Material Separation 706 706
Difficult to Remove 534 534
Material Twisted/Bent 468 468
Fluid/Blood Leak 452 452
Fracture 429 429
Material Integrity Problem 413 413
Deflation Problem 390 390
Failure to Advance 383 383
Unraveled Material 359 359
Difficult to Advance 359 359
Crack 336 336
Material Split, Cut or Torn 306 306
Inflation Problem 240 240
Entrapment of Device 224 224
Peeled/Delaminated 202 202
Burst Container or Vessel 199 199
Retraction Problem 183 183
Device Damaged Prior to Use 168 168
Material Frayed 162 162
Material Puncture/Hole 154 154
Insufficient Information 146 146
Obstruction of Flow 127 127
Difficult to Insert 126 126
Accessory Incompatible 114 114
Use of Device Problem 114 114
Device Dislodged or Dislocated 109 109
Device Damaged by Another Device 107 107
Incorrect, Inadequate or Imprecise Result or Readings 84 84
Packaging Problem 80 80
Complete Blockage 77 77
Device-Device Incompatibility 77 77
Improper or Incorrect Procedure or Method 76 76
Stretched 73 73
Air/Gas in Device 70 70
Mechanical Problem 70 70
Material Fragmentation 62 62
Gas/Air Leak 61 61
No Apparent Adverse Event 60 60
Device Contamination with Chemical or Other Material 57 57
Patient Device Interaction Problem 50 50
Appropriate Term/Code Not Available 47 47
Migration 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3649 3649
No Known Impact Or Consequence To Patient 766 766
No Clinical Signs, Symptoms or Conditions 519 519
No Patient Involvement 298 298
Vascular Dissection 166 166
Device Embedded In Tissue or Plaque 132 132
Death 76 76
No Information 74 74
No Code Available 73 73
Pericardial Effusion 70 70
Foreign Body In Patient 70 70
Perforation of Vessels 70 70
Injury 50 50
Hematoma 48 48
Embolism 42 42
Cardiac Perforation 38 38
Cardiac Tamponade 36 36
Low Blood Pressure/ Hypotension 36 36
Perforation 36 36
Insufficient Information 34 34
Thrombosis 34 34
Rupture 30 30
Vasoconstriction 30 30
Vessel Or Plaque, Device Embedded In 29 29
Hemorrhage/Bleeding 28 28
Blood Loss 27 27
Stroke/CVA 24 24
Occlusion 24 24
Air Embolism 22 22
Patient Problem/Medical Problem 20 20
Aneurysm 20 20
Thrombus 19 19
Myocardial Infarction 17 17
Unspecified Infection 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Obstruction/Occlusion 16 16
Pseudoaneurysm 15 15
Embolism/Embolus 14 14
Cardiac Arrest 13 13
Intracranial Hemorrhage 11 11
Intimal Dissection 11 11
Needle Stick/Puncture 10 10
Infarction, Cerebral 10 10
Thromboembolism 10 10
Great Vessel Perforation 10 10
Fistula 9 9
Embolus 9 9
Reaction 9 9
Tachycardia 8 8
Pulmonary Embolism 8 8

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 Arrow International Inc II Apr-10-2019
5 Arrow International Inc II Jan-11-2019
6 Bard Peripheral Vascular Inc II Oct-08-2020
7 Boston Scientific Corporation II Oct-03-2023
8 Boston Scientific Corporation II Aug-25-2022
9 Boston Scientific Corporation II Apr-15-2021
10 Boston Scientific Corporation II Jan-15-2021
11 Boston Scientific Corporation II Nov-26-2019
12 Cook Inc. II Jun-02-2020
13 Cook Incorporated II Jul-08-2022
14 Cordis Corporation III Apr-18-2019
15 MICROVENTION INC. III Jun-07-2021
16 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
17 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
18 Medtronic Vascular II Mar-11-2021
19 Medtronic Vascular I Oct-01-2019
20 Merit Medical Systems, Inc. II Jan-02-2024
21 Mivi Neuroscience Inc II Sep-09-2021
22 ROUTE 92 MEDICAL INC I Apr-24-2024
23 Scientia Vascular, Inc. II Mar-13-2023
24 Stryker Neurovascular II May-28-2024
25 Stryker Neurovascular II May-01-2024
26 Stryker Neurovascular II Oct-08-2019
27 Stryker Neurovascular II Jun-02-2019
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