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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 5
ACCESS SCIENTIFIC, 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 2
C.R. BARD, INC
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CATHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
CREGANNA MEDICAL ALSO DOING BUSINESS AS CEGANNA TACTX MEDICA
  SUBSTANTIALLY EQUIVALENT 1
CRUZAR MEDSYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 4
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
INARI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO INC.
  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 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2
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
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
ORBUSNEICH MEDICAL TRADING INC.
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL
  SUBSTANTIALLY EQUIVALENT 2
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 3
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
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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRACTUS VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
TRANSIT SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 2
TRAVERSE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD
  SUBSTANTIALLY EQUIVALENT 1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 5
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE AND ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
XABLECATH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2854 2854
2019 2902 2902
2020 2891 2891
2021 3009 3009
2022 2645 2645
2023 419 419

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3031 3031
Adverse Event Without Identified Device or Use Problem 1793 1793
Break 1419 1419
Material Deformation 1383 1383
Detachment of Device or Device Component 960 960
Physical Resistance/Sticking 780 780
Leak/Splash 677 677
Failure to Advance 507 507
Deformation Due to Compressive Stress 477 477
Material Separation 461 461
Difficult to Remove 413 413
Deflation Problem 389 389
Fluid/Blood Leak 378 378
Device Damaged Prior to Use 371 371
Material Integrity Problem 348 348
Unraveled Material 333 333
Peeled/Delaminated 305 305
Fracture 295 295
Crack 274 274
Difficult to Advance 270 270
Retraction Problem 227 227
Inflation Problem 212 212
Burst Container or Vessel 194 194
Material Split, Cut or Torn 190 190
Entrapment of Device 189 189
Material Frayed 186 186
Kinked 184 184
Material Twisted/Bent 142 142
Difficult to Insert 137 137
Material Puncture/Hole 125 125
Device Damaged by Another Device 107 107
Mechanical Problem 106 106
Insufficient Information 102 102
Detachment Of Device Component 97 97
Obstruction of Flow 86 86
Use of Device Problem 83 83
Device Dislodged or Dislocated 81 81
Material Fragmentation 75 75
Complete Blockage 72 72
Physical Resistance 68 68
Device Contamination with Chemical or Other Material 65 65
Accessory Incompatible 63 63
Device-Device Incompatibility 59 59
Stretched 54 54
Out-Of-Box Failure 51 51
Separation Problem 50 50
Gas/Air Leak 48 48
Improper or Incorrect Procedure or Method 47 47
Appropriate Term/Code Not Available 43 43
Unsealed Device Packaging 40 40
Packaging Problem 38 38
Device Markings/Labelling Problem 37 37
Biocompatibility 34 34
Defective Device 34 34
Migration or Expulsion of Device 32 32
Migration 31 31
Unable to Obtain Readings 30 30
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Connection Problem 28 28
No Apparent Adverse Event 28 28
Hole In Material 27 27
Component Missing 26 26
Device Operates Differently Than Expected 26 26
Manufacturing, Packaging or Shipping Problem 26 26
Positioning Problem 26 26
Fitting Problem 24 24
Patient Device Interaction Problem 23 23
Air/Gas in Device 22 22
Tear, Rip or Hole in Device Packaging 22 22
Bent 22 22
Partial Blockage 22 22
Loose or Intermittent Connection 21 21
Device Sensing Problem 21 21
Activation, Positioning or Separation Problem 21 21
Contamination 20 20
Defective Component 19 19
Device Handling Problem 19 19
Material Perforation 17 17
Patient-Device Incompatibility 16 16
Torn Material 16 16
Unintended Movement 16 16
Mechanical Jam 15 15
Device Contaminated During Manufacture or Shipping 15 15
Collapse 14 14
Air Leak 13 13
Compatibility Problem 13 13
Split 12 12
Dull, Blunt 12 12
Difficult to Flush 12 12
Failure to Deflate 12 12
Delivered as Unsterile Product 11 11
Infusion or Flow Problem 10 10
Material Too Soft/Flexible 10 10
Device Fell 9 9
Contamination /Decontamination Problem 9 9
Sticking 9 9
Material Too Rigid or Stiff 9 9
Difficult or Delayed Positioning 8 8
Expulsion 8 8
Separation Failure 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5345 5345
No Clinical Signs, Symptoms or Conditions 4530 4530
No Known Impact Or Consequence To Patient 1288 1288
No Patient Involvement 579 579
Vascular Dissection 382 382
Insufficient Information 358 358
Foreign Body In Patient 295 295
Device Embedded In Tissue or Plaque 273 273
Pericardial Effusion 226 226
No Information 169 169
Thrombosis/Thrombus 161 161
Hematoma 150 150
Perforation of Vessels 148 148
Hemorrhage/Bleeding 140 140
Low Blood Pressure/ Hypotension 127 127
No Code Available 123 123
Cardiac Perforation 121 121
Intracranial Hemorrhage 121 121
Stroke/CVA 120 120
Perforation 107 107
Cardiac Tamponade 102 102
Death 100 100
Vasoconstriction 99 99
Obstruction/Occlusion 80 80
Rupture 69 69
Air Embolism 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
Embolism/Embolus 64 64
Thromboembolism 59 59
Injury 57 57
Pseudoaneurysm 49 49
Stenosis 45 45
Embolism 45 45
Thrombosis 41 41
Patient Problem/Medical Problem 41 41
Vessel Or Plaque, Device Embedded In 40 40
Cardiac Arrest 39 39
Swelling/ Edema 38 38
Unspecified Nervous System Problem 35 35
Myocardial Infarction 35 35
Occlusion 35 35
Blood Loss 33 33
Pain 31 31
Aneurysm 30 30
Non specific EKG/ECG Changes 28 28
Unspecified Infection 28 28
Ruptured Aneurysm 27 27
Thrombus 26 26
Arrhythmia 25 25
Bradycardia 25 25
Intimal Dissection 23 23
Chest Pain 23 23
Ischemia 23 23
Transient Ischemic Attack 23 23
Restenosis 23 23
Unspecified Tissue Injury 22 22
Ischemia Stroke 20 20
Extravasation 20 20
Fistula 20 20
Tachycardia 19 19
Paralysis 16 16
Needle Stick/Puncture 15 15
Ventricular Fibrillation 14 14
High Blood Pressure/ Hypertension 14 14
Calcium Deposits/Calcification 14 14
Infarction, Cerebral 13 13
Dyspnea 13 13
Discomfort 13 13
Great Vessel Perforation 13 13
Reaction 12 12
Foreign Body Embolism 12 12
Dysphasia 11 11
ST Segment Elevation 11 11
Muscle Weakness 10 10
Fever 10 10
Headache 10 10
Hemorrhage, Cerebral 9 9
Embolus 9 9
Pulmonary Embolism 9 9
Sepsis 9 9
Tissue Damage 9 9
Loss of consciousness 9 9
Cognitive Changes 8 8
Paresis 8 8
Pneumothorax 8 8
Atrial Fibrillation 8 8
Nausea 8 8
Renal Failure 7 7
Visual Impairment 7 7
Heart Failure 7 7
Low Oxygen Saturation 7 7
Convulsion/Seizure 7 7
Cramp(s) /Muscle Spasm(s) 7 7
Respiratory Failure 6 6
Iatrogenic Source 6 6
Aortic Dissection 6 6
Blurred Vision 6 6
Neurological Deficit/Dysfunction 6 6
Hemorrhage, Subarachnoid 6 6
Aspiration/Inhalation 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Apr-07-2022
2 Arrow International Inc II Feb-14-2020
3 Arrow International Inc II Apr-10-2019
4 Arrow International Inc II Jan-11-2019
5 Arrow International Inc II Jun-29-2018
6 Arrow International Inc II May-30-2018
7 Arrow International Inc II Apr-10-2018
8 Arrow International Inc II Feb-20-2018
9 Bard Peripheral Vascular Inc II Oct-08-2020
10 Bard Peripheral Vascular Inc II May-11-2018
11 Boston Scientific Corporation II Aug-25-2022
12 Boston Scientific Corporation II Apr-15-2021
13 Boston Scientific Corporation II Jan-15-2021
14 Boston Scientific Corporation II Nov-26-2019
15 Boston Scientific Corporation II Aug-08-2018
16 Cook Inc. II Jun-02-2020
17 Cook Inc. II Apr-25-2018
18 Cook Inc. II Mar-09-2018
19 Cook Incorporated II Jul-08-2022
20 Cordis Corporation III Apr-18-2019
21 MICROVENTION INC. III Jun-07-2021
22 Medtronic Inc I Mar-29-2018
23 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
24 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
25 Medtronic Vascular II Mar-11-2021
26 Medtronic Vascular I Oct-01-2019
27 Mivi Neuroscience Inc II Sep-09-2021
28 SPS Sterilization, Inc II Sep-13-2018
29 Scientia Vascular, Inc. II Mar-13-2023
30 Stryker Neurovascular II Oct-08-2019
31 Stryker Neurovascular II Jun-02-2019
32 Stryker Neurovascular II Sep-28-2018
33 Stryker Neurovascular II Jul-28-2018
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