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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 1
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
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 5
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, 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
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 3072 3135
2024 1097 1097

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3150 3150
Adverse Event Without Identified Device or Use Problem 2285 2348
Break 1373 1373
Material Deformation 1339 1339
Detachment of Device or Device Component 1001 1001
Physical Resistance/Sticking 896 896
Deformation Due to Compressive Stress 726 726
Leak/Splash 694 694
Material Separation 627 627
Difficult to Remove 489 489
Fluid/Blood Leak 417 417
Fracture 382 382
Failure to Advance 374 374
Deflation Problem 370 370
Material Integrity Problem 366 366
Unraveled Material 328 328
Difficult to Advance 320 320
Material Twisted/Bent 306 306
Crack 303 303
Material Split, Cut or Torn 262 262
Inflation Problem 221 221
Entrapment of Device 209 209
Burst Container or Vessel 191 191
Peeled/Delaminated 187 187
Retraction Problem 180 180
Device Damaged Prior to Use 165 165
Material Frayed 157 157
Material Puncture/Hole 140 140
Obstruction of Flow 121 121
Insufficient Information 119 119
Difficult to Insert 114 114
Device Dislodged or Dislocated 103 103
Use of Device Problem 100 100
Accessory Incompatible 99 99
Device Damaged by Another Device 99 99
Complete Blockage 74 74
Improper or Incorrect Procedure or Method 72 72
Device-Device Incompatibility 72 72
Packaging Problem 68 68
Mechanical Problem 66 66
Incorrect, Inadequate or Imprecise Result or Readings 65 65
Stretched 64 64
Material Fragmentation 61 61
Air/Gas in Device 60 60
Gas/Air Leak 56 56
Device Contamination with Chemical or Other Material 54 54
Appropriate Term/Code Not Available 45 45
Unsealed Device Packaging 44 44
Separation Problem 42 42
No Apparent Adverse Event 40 40
Unable to Obtain Readings 40 40
Patient Device Interaction Problem 40 40
Tear, Rip or Hole in Device Packaging 39 39
Positioning Problem 37 37
Migration 35 35
Failure to Deflate 35 35
Device Markings/Labelling Problem 34 34
Biocompatibility 34 34
Defective Device 31 31
Migration or Expulsion of Device 31 31
Fitting Problem 28 28
Component Missing 27 27
Contamination 26 26
Manufacturing, Packaging or Shipping Problem 25 25
Activation, Positioning or Separation Problem 24 24
Connection Problem 22 22
Unintended Movement 22 22
Device Sensing Problem 21 21
Patient-Device Incompatibility 20 20
Loose or Intermittent Connection 20 20
Device Contaminated During Manufacture or Shipping 18 18
Contamination /Decontamination Problem 16 16
Dull, Blunt 16 16
Difficult to Flush 16 16
Material Perforation 14 14
Off-Label Use 14 14
Product Quality Problem 13 13
Defective Component 12 12
Premature Separation 12 12
Difficult or Delayed Positioning 11 11
Collapse 11 11
Infusion or Flow Problem 11 11
Delivered as Unsterile Product 10 10
Improper Flow or Infusion 9 9
Component Misassembled 9 9
Device Handling Problem 9 9
Difficult to Open or Remove Packaging Material 9 9
Expulsion 8 8
Material Too Soft/Flexible 7 7
Material Too Rigid or Stiff 7 7
Device Fell 7 7
Unclear Information 6 6
Suction Problem 6 6
Flaked 6 6
No Flow 6 6
Malposition of Device 6 6
Separation Failure 6 6
Disconnection 5 5
Device Difficult to Setup or Prepare 5 5
Suction Failure 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7136 7136
No Consequences Or Impact To Patient 3671 3671
No Known Impact Or Consequence To Patient 766 766
Insufficient Information 577 577
Vascular Dissection 446 446
Foreign Body In Patient 363 363
Pericardial Effusion 302 302
No Patient Involvement 299 299
Thrombosis/Thrombus 293 293
Hemorrhage/Bleeding 223 286
Intracranial Hemorrhage 205 268
Hematoma 202 265
Device Embedded In Tissue or Plaque 200 200
Low Blood Pressure/ Hypotension 189 189
Perforation of Vessels 174 174
Stroke/CVA 155 155
Cardiac Perforation 151 151
Cardiac Tamponade 137 137
Vasoconstriction 126 126
Obstruction/Occlusion 126 126
Perforation 115 115
Embolism/Embolus 101 101
Air Embolism 99 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 89 89
Rupture 86 86
Death 76 76
No Information 75 75
No Code Available 73 73
Thromboembolism 69 69
Unspecified Nervous System Problem 68 68
Pseudoaneurysm 66 66
Ischemia Stroke 65 65
Cardiac Arrest 62 62
Non specific EKG/ECG Changes 62 62
Swelling/ Edema 60 60
Myocardial Infarction 52 52
Injury 50 50
Stenosis 49 49
Pain 47 47
Ischemia 45 45
Embolism 42 42
Aneurysm 38 38
Ruptured Aneurysm 36 36
Arrhythmia 35 35
Bradycardia 35 35
Thrombosis 34 34
Vessel Or Plaque, Device Embedded In 29 29
Unspecified Infection 29 29
Unspecified Tissue Injury 28 28
Blood Loss 27 27
Transient Ischemic Attack 27 27
Tachycardia 26 26
Restenosis 26 26
Occlusion 24 24
Extravasation 23 23
Patient Problem/Medical Problem 20 20
Fistula 19 19
Discomfort 19 19
Thrombus 19 19
Muscle Weakness 18 18
High Blood Pressure/ Hypertension 18 18
Chest Pain 18 18
Headache 17 17
Dyspnea 16 16
Needle Stick/Puncture 16 16
Foreign Body Embolism 15 15
Sepsis 15 15
Dysphasia 15 15
Great Vessel Perforation 15 15
Paralysis 14 14
Paresis 13 13
Ventricular Fibrillation 13 13
Fever 13 13
Cerebral Edema 13 13
Cognitive Changes 13 13
Asystole 13 13
Heart Block 13 13
Heart Failure/Congestive Heart Failure 13 13
Convulsion/Seizure 12 12
Inflammation 12 12
Atrial Fibrillation 12 12
Intimal Dissection 11 11
Low Oxygen Saturation 11 11
Loss of consciousness 11 11
Hemorrhagic Stroke 10 10
Retroperitoneal Hemorrhage 10 10
Pulmonary Embolism 10 10
Infarction, Cerebral 10 10
Nausea 10 10
Pneumothorax 9 9
Visual Disturbances 9 9
Embolus 9 9
Reaction 9 9
Confusion/ Disorientation 8 8
Calcium Deposits/Calcification 8 8
Aspiration/Inhalation 8 8
Hypoxia 8 8
Visual Impairment 8 8
Failure of Implant 8 8
Pneumonia 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 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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