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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 7
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 2
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 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
EOSOLUTIONS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEXACATH
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 5
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 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
OKAMI MEDICAL, INC.
  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
SURMODICS. INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL 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
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
  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 2889 2889
2021 3009 3009
2022 2646 2646
2023 2758 2821

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3424 3424
Adverse Event Without Identified Device or Use Problem 2188 2251
Break 1636 1636
Material Deformation 1487 1487
Detachment of Device or Device Component 1076 1076
Physical Resistance/Sticking 911 911
Leak/Splash 800 800
Deformation Due to Compressive Stress 727 727
Material Separation 627 627
Failure to Advance 523 523
Difficult to Remove 490 490
Fluid/Blood Leak 435 435
Deflation Problem 414 414
Unraveled Material 397 397
Material Integrity Problem 396 396
Fracture 375 375
Device Damaged Prior to Use 374 374
Difficult to Advance 331 331
Peeled/Delaminated 320 320
Crack 313 313
Material Split, Cut or Torn 240 240
Retraction Problem 236 236
Inflation Problem 234 234
Entrapment of Device 226 226
Burst Container or Vessel 206 206
Material Frayed 199 199
Kinked 184 184
Material Twisted/Bent 175 175
Difficult to Insert 148 148
Material Puncture/Hole 145 145
Obstruction of Flow 131 131
Insufficient Information 122 122
Device Damaged by Another Device 121 121
Mechanical Problem 115 115
Use of Device Problem 104 104
Device Dislodged or Dislocated 102 102
Detachment Of Device Component 97 97
Accessory Incompatible 80 80
Material Fragmentation 79 79
Complete Blockage 76 76
Device Contamination with Chemical or Other Material 71 71
Device-Device Incompatibility 70 70
Physical Resistance 68 68
Packaging Problem 66 66
Improper or Incorrect Procedure or Method 64 64
Stretched 64 64
Incorrect, Inadequate or Imprecise Result or Readings 62 62
Gas/Air Leak 52 52
Air/Gas in Device 52 52
Out-Of-Box Failure 51 51
Separation Problem 50 50
Appropriate Term/Code Not Available 49 49
Unsealed Device Packaging 45 45
Tear, Rip or Hole in Device Packaging 43 43
No Apparent Adverse Event 41 41
Migration or Expulsion of Device 40 40
Unable to Obtain Readings 39 39
Defective Device 38 38
Device Markings/Labelling Problem 37 37
Migration 36 36
Biocompatibility 34 34
Positioning Problem 31 31
Patient Device Interaction Problem 29 29
Failure to Deflate 29 29
Connection Problem 29 29
Fitting Problem 28 28
Component Missing 27 27
Manufacturing, Packaging or Shipping Problem 27 27
Hole In Material 27 27
Device Operates Differently Than Expected 26 26
Activation, Positioning or Separation Problem 23 23
Bent 22 22
Partial Blockage 22 22
Loose or Intermittent Connection 22 22
Contamination 21 21
Device Sensing Problem 21 21
Defective Component 20 20
Device Handling Problem 20 20
Unintended Movement 19 19
Material Perforation 19 19
Patient-Device Incompatibility 18 18
Device Contaminated During Manufacture or Shipping 16 16
Dull, Blunt 16 16
Torn Material 16 16
Off-Label Use 15 15
Collapse 14 14
Air Leak 13 13
Difficult to Flush 13 13
Compatibility Problem 13 13
Contamination /Decontamination Problem 13 13
Mechanical Jam 13 13
Infusion or Flow Problem 12 12
Split 12 12
Difficult or Delayed Positioning 12 12
Delivered as Unsterile Product 11 11
Material Too Rigid or Stiff 10 10
Material Too Soft/Flexible 10 10
Premature Separation 10 10
Device Fell 9 9
Component Misassembled 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6170 6170
No Consequences Or Impact To Patient 5345 5345
No Known Impact Or Consequence To Patient 1286 1286
No Patient Involvement 579 579
Insufficient Information 506 506
Vascular Dissection 455 455
Foreign Body In Patient 364 364
Device Embedded In Tissue or Plaque 288 288
Pericardial Effusion 285 285
Thrombosis/Thrombus 242 242
Hemorrhage/Bleeding 195 258
Hematoma 189 252
Perforation of Vessels 171 171
No Information 169 169
Low Blood Pressure/ Hypotension 165 165
Intracranial Hemorrhage 164 227
Stroke/CVA 149 149
Cardiac Perforation 143 143
Cardiac Tamponade 128 128
Vasoconstriction 126 126
No Code Available 123 123
Perforation 122 122
Death 100 100
Obstruction/Occlusion 100 100
Air Embolism 96 96
Embolism/Embolus 89 89
Rupture 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Thromboembolism 65 65
Pseudoaneurysm 60 60
Injury 57 57
Cardiac Arrest 56 56
Non specific EKG/ECG Changes 53 53
Swelling/ Edema 52 52
Stenosis 51 51
Pain 47 47
Myocardial Infarction 46 46
Unspecified Nervous System Problem 46 46
Embolism 45 45
Thrombosis 41 41
Patient Problem/Medical Problem 41 41
Vessel Or Plaque, Device Embedded In 40 40
Ischemia 40 40
Aneurysm 36 36
Arrhythmia 35 35
Occlusion 35 35
Bradycardia 34 34
Blood Loss 33 33
Ruptured Aneurysm 33 33
Unspecified Infection 31 31
Ischemia Stroke 29 29
Transient Ischemic Attack 28 28
Unspecified Tissue Injury 27 27
Thrombus 26 26
Tachycardia 26 26
Chest Pain 24 24
Restenosis 24 24
Intimal Dissection 23 23
Extravasation 22 22
Fistula 22 22
High Blood Pressure/ Hypertension 20 20
Discomfort 20 20
Dyspnea 17 17
Headache 16 16
Sepsis 16 16
Paralysis 16 16
Ventricular Fibrillation 16 16
Needle Stick/Puncture 16 16
Muscle Weakness 14 14
Calcium Deposits/Calcification 14 14
Infarction, Cerebral 13 13
Great Vessel Perforation 13 13
Dysphasia 13 13
Foreign Body Embolism 13 13
Reaction 12 12
Atrial Fibrillation 12 12
Fever 12 12
Inflammation 11 11
ST Segment Elevation 11 11
Low Oxygen Saturation 11 11
Loss of consciousness 10 10
Convulsion/Seizure 10 10
Asystole 10 10
Heart Block 10 10
Paresis 10 10
Nausea 10 10
Pulmonary Embolism 10 10
Embolus 9 9
Hemorrhage, Cerebral 9 9
Tissue Damage 9 9
Heart Failure/Congestive Heart Failure 9 9
Cognitive Changes 9 9
Respiratory Failure 8 8
Retroperitoneal Hemorrhage 8 8
Renal Failure 8 8
Pneumothorax 8 8
Visual Impairment 8 8
Heart Failure 7 7
Hypoxia 7 7
Aspiration/Inhalation 7 7

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 Arrow International Inc II Jun-29-2018
7 Arrow International Inc II May-30-2018
8 Arrow International Inc II Apr-10-2018
9 Arrow International Inc II Feb-20-2018
10 Bard Peripheral Vascular Inc II Oct-08-2020
11 Bard Peripheral Vascular Inc II May-11-2018
12 Boston Scientific Corporation II Oct-03-2023
13 Boston Scientific Corporation II Aug-25-2022
14 Boston Scientific Corporation II Apr-15-2021
15 Boston Scientific Corporation II Jan-15-2021
16 Boston Scientific Corporation II Nov-26-2019
17 Boston Scientific Corporation II Aug-08-2018
18 Cook Inc. II Jun-02-2020
19 Cook Inc. II Apr-25-2018
20 Cook Inc. II Mar-09-2018
21 Cook Incorporated II Jul-08-2022
22 Cordis Corporation III Apr-18-2019
23 MICROVENTION INC. III Jun-07-2021
24 Medtronic Inc I Mar-29-2018
25 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II May-27-2022
26 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) II Oct-22-2021
27 Medtronic Vascular II Mar-11-2021
28 Medtronic Vascular I Oct-01-2019
29 Mivi Neuroscience Inc II Sep-09-2021
30 SPS Sterilization, Inc II Sep-13-2018
31 Scientia Vascular, Inc. II Mar-13-2023
32 Stryker Neurovascular II Oct-08-2019
33 Stryker Neurovascular II Jun-02-2019
34 Stryker Neurovascular II Sep-28-2018
35 Stryker Neurovascular II Jul-28-2018
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