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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 3
ACCESS SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ACROSTAK (SCHWEIZ) AG
  SUBSTANTIALLY EQUIVALENT 1
AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST. JUDE MEDICAL CO
  SUBSTANTIALLY EQUIVALENT 1
AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELELFLEX INC.)
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
ASHITAKA FACTORY OF TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BALT USA LLC
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCARDIA
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CATHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONCENTRIC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CREGANNA MEDICAL ALSO DOING BUSINESS AS CEGANNA TACTX MEDICA
  SUBSTANTIALLY EQUIVALENT 1
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CURATIA MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
HAOLANG MEDICAL USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL COMPONENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMDS OPERATIONS B.V.
  SUBSTANTIALLY EQUIVALENT 4
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
INNEUROCO, INC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.(FORMERLY EV3 INC.)
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
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
MICROTHERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC., A TERUMO GROUP COMPANY
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
MIVI NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
NITILOOP LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 2
REFLOW MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
REFLOW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROXWOOD MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ROXWOOD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIENTIA VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
SEQUENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 3
SUREFIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TEXAS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TNI MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRACTUS VASCULAR LLC
  SUBSTANTIALLY EQUIVALENT 2
TRANSIT SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
TRANSIT SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 5
VASCULAR SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE AND ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 1
XABLECATH, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 2249 2249
2017 2486 2486
2018 2854 2854
2019 2902 2902
2020 2890 2890
2021 2247 2247

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3049 3049
Break 1726 1726
Adverse Event Without Identified Device or Use Problem 1506 1506
Material Deformation 1283 1283
Detachment of Device or Device Component 909 909
Leak/Splash 730 730
Kinked 696 696
Failure to Advance 641 641
Physical Resistance/Sticking 604 604
Device Damaged Prior to Use 541 541
Material Separation 462 462
Deflation Problem 431 431
Retraction Problem 419 419
Difficult to Remove 376 376
Detachment Of Device Component 368 368
Physical Resistance 345 345
Material Integrity Problem 342 342
Unraveled Material 340 340
Peeled/Delaminated 325 325
Fluid Leak 324 324
Fracture 311 311
Burst Container or Vessel 294 294
Crack 277 277
Difficult to Advance 240 240
Material Frayed 229 229
Entrapment of Device 224 224
Inflation Problem 209 209
Out-Of-Box Failure 186 186
Deformation Due to Compressive Stress 179 179
Difficult to Insert 177 177
Mechanical Problem 170 170
Device Operates Differently Than Expected 156 156
Material Twisted/Bent 134 134
Material Split, Cut or Torn 133 133
Device Damaged by Another Device 125 125
Material Fragmentation 111 111
Material Puncture/Hole 100 100
Bent 94 94
Device Contamination with Chemical or Other Material 88 88
Hole In Material 87 87
Insufficient Information 86 86
Device-Device Incompatibility 86 86
Connection Problem 83 83
Complete Blockage 74 74
Stretched 62 62
Use of Device Problem 62 62
Device Dislodged or Dislocated 59 59
Device Markings/Labelling Problem 55 55
Torn Material 54 54
Obstruction of Flow 54 54
Migration or Expulsion of Device 53 53
Accessory Incompatible 49 49
Separation Problem 47 47
Appropriate Term/Code Not Available 45 45
Gas Leak 43 43
Device Handling Problem 41 41
Unsealed Device Packaging 38 38
Defective Device 38 38
Partial Blockage 36 36
Split 35 35
Improper or Incorrect Procedure or Method 34 34
Sticking 33 33
Packaging Problem 32 32
Mechanical Jam 29 29
Component Missing 28 28
Biocompatibility 28 28
Air Leak 27 27
Manufacturing, Packaging or Shipping Problem 25 25
Positioning Problem 23 23
Migration 22 22
Device Sensing Problem 22 22
Contamination 22 22
Occlusion Within Device 22 22
Loose or Intermittent Connection 22 22
Material Perforation 22 22
Activation, Positioning or SeparationProblem 22 22
Unable to Obtain Readings 20 20
Tear, Rip or Hole in Device Packaging 20 20
Defective Component 19 19
Collapse 18 18
Human-Device Interface Problem 15 15
Compatibility Problem 15 15
Unintended Movement 15 15
Fitting Problem 14 14
Disconnection 14 14
No Apparent Adverse Event 14 14
No Flow 13 13
Patient Device Interaction Problem 13 13
Device Operational Issue 13 13
Patient-Device Incompatibility 13 13
Delivered as Unsterile Product 13 13
Folded 12 12
Cut In Material 11 11
Difficult to Flush 11 11
Product Quality Problem 11 11
Device Contaminated During Manufacture or Shipping 11 11
Material Distortion 11 11
Device Expiration Issue 10 10
Material Too Rigid or Stiff 10 10
Material Too Soft/Flexible 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8196 8196
No Known Impact Or Consequence To Patient 2022 2022
No Clinical Signs, Symptoms or Conditions 1937 1937
No Patient Involvement 937 937
Device Embedded In Tissue or Plaque 374 374
Vascular Dissection 366 366
Foreign Body In Patient 224 224
No Information 219 219
No Code Available 193 193
Pericardial Effusion 176 176
Death 169 169
Perforation of Vessels 160 160
Insufficient Information 123 123
Hematoma 108 108
Cardiac Perforation 104 104
Low Blood Pressure/ Hypotension 96 96
Perforation 94 94
Vasoconstriction 84 84
Cardiac Tamponade 80 80
Patient Problem/Medical Problem 76 76
Hemorrhage/Bleeding 76 76
Injury 75 75
Vessel Or Plaque, Device Embedded In 73 73
Rupture 66 66
Intimal Dissection 61 61
Embolism 60 60
Occlusion 56 56
Thrombosis 55 55
Blood Loss 47 47
Stenosis 46 46
Air Embolism 44 44
Thrombosis/Thrombus 43 43
Stroke/CVA 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Thrombus 39 39
Aneurysm 36 36
Obstruction/Occlusion 34 34
Headache 31 31
Cardiac Arrest 30 30
Intracranial Hemorrhage 30 30
Pseudoaneurysm 29 29
Myocardial Infarction 28 28
Pain 26 26
Unspecified Infection 25 25
Hemorrhage, Subarachnoid 23 23
Extravasation 23 23
Restenosis 22 22
Fistula 21 21
Infarction, Cerebral 21 21
Thromboembolism 19 19
Calcium Deposits/Calcification 19 19
Hemorrhage, Cerebral 19 19
Embolism/Embolus 18 18
Swelling/ Edema 18 18
Chest Pain 18 18
Tachycardia 16 16
Tissue Damage 16 16
Unspecified Tissue Injury 16 16
Reaction 15 15
Embolus 14 14
ST Segment Elevation 14 14
Neurological Deficit/Dysfunction 13 13
Pneumothorax 13 13
Needle Stick/Puncture 13 13
Great Vessel Perforation 12 12
Heart Failure 12 12
Transient Ischemic Attack 12 12
Dyspnea 11 11
Unspecified Nervous System Problem 11 11
Discomfort 10 10
Reocclusion 10 10
Arrhythmia 10 10
Pulmonary Embolism 10 10
Ischemia 10 10
Aortic Dissection 10 10
Paralysis 9 9
Ventricular Fibrillation 9 9
Ruptured Aneurysm 9 9
Bradycardia 8 8
Edema 8 8
Fever 8 8
High Blood Pressure/ Hypertension 7 7
Atrial Fibrillation 7 7
Peripheral Vascular Disease 7 7
Ischemia Stroke 6 6
Iatrogenic Source 6 6
Sepsis 6 6
Paresis 6 6
Ventricular Tachycardia 6 6
Low Oxygen Saturation 6 6
Muscle Spasm(s) 6 6
Hypovolemic Shock 5 5
Non specific EKG/ECG Changes 5 5
Renal Failure 5 5
Swelling 5 5
Vascular System (Circulation), Impaired 5 5
Shock 5 5
Syncope 5 5
Nausea 5 5
Foreign Body Reaction 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-14-2020
2 Arrow International Inc II Apr-10-2019
3 Arrow International Inc II Jan-11-2019
4 Arrow International Inc II Jun-29-2018
5 Arrow International Inc II May-30-2018
6 Arrow International Inc II Apr-10-2018
7 Arrow International Inc II Feb-20-2018
8 Arrow International Inc II Jun-12-2017
9 Bard Peripheral Vascular Inc II Oct-08-2020
10 Bard Peripheral Vascular Inc II May-11-2018
11 Boston Scientific Corporation II Apr-15-2021
12 Boston Scientific Corporation II Jan-15-2021
13 Boston Scientific Corporation II Nov-26-2019
14 Boston Scientific Corporation II Aug-08-2018
15 Boston Scientific Corporation II Jan-05-2016
16 Cook Inc. II Jun-02-2020
17 Cook Inc. II Apr-25-2018
18 Cook Inc. II Mar-09-2018
19 Cook Inc. II Aug-22-2016
20 Cook Inc. I Feb-24-2016
21 Cordis Corporation III Apr-18-2019
22 MICROVENTION INC. III Jun-07-2021
23 Medtronic Inc I Mar-29-2018
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 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
28 Mivi Neuroscience Inc II Sep-09-2021
29 ReFlow Medical I Mar-29-2017
30 SPS Sterilization, Inc II Sep-13-2018
31 Stryker Neurovascular II Oct-08-2019
32 Stryker Neurovascular II Jun-02-2019
33 Stryker Neurovascular II Sep-28-2018
34 Stryker Neurovascular II Jul-28-2018
35 Stryker Neurovascular II Nov-02-2016
36 Vascular Solutions, Inc. I May-22-2017
37 Vascular Solutions, Inc. I Oct-20-2016
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