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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 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
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 1396 1396

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 3201 3201
Adverse Event Without Identified Device or Use Problem 2335 2398
Break 1381 1381
Material Deformation 1358 1358
Detachment of Device or Device Component 1016 1016
Physical Resistance/Sticking 912 912
Deformation Due to Compressive Stress 727 727
Leak/Splash 708 708
Material Separation 653 653
Difficult to Remove 497 497
Fluid/Blood Leak 428 428
Fracture 393 393
Failure to Advance 377 377
Material Integrity Problem 374 374
Deflation Problem 374 374
Material Twisted/Bent 344 344
Unraveled Material 340 340
Difficult to Advance 332 332
Crack 309 309
Material Split, Cut or Torn 269 269
Inflation Problem 226 226
Entrapment of Device 215 215
Burst Container or Vessel 192 192
Peeled/Delaminated 189 189
Retraction Problem 180 180
Device Damaged Prior to Use 165 165
Material Frayed 158 158
Material Puncture/Hole 144 144
Insufficient Information 126 126
Obstruction of Flow 124 124
Difficult to Insert 114 114
Device Dislodged or Dislocated 104 104
Device Damaged by Another Device 103 103
Accessory Incompatible 103 103
Use of Device Problem 103 103
Packaging Problem 75 75
Complete Blockage 74 74
Improper or Incorrect Procedure or Method 73 73
Device-Device Incompatibility 73 73
Mechanical Problem 67 67
Incorrect, Inadequate or Imprecise Result or Readings 66 66
Stretched 65 65
Air/Gas in Device 63 63
Material Fragmentation 61 61
Gas/Air Leak 57 57
Device Contamination with Chemical or Other Material 54 54
Appropriate Term/Code Not Available 45 45
Unsealed Device Packaging 45 45
Separation Problem 42 42
Unable to Obtain Readings 41 41
No Apparent Adverse Event 41 41
Patient Device Interaction Problem 40 40
Tear, Rip or Hole in Device Packaging 39 39
Positioning Problem 37 37
Migration 36 36
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 29 29
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 21 21
Loose or Intermittent Connection 21 21
Device Contaminated During Manufacture or Shipping 18 18
Contamination /Decontamination Problem 16 16
Dull, Blunt 16 16
Difficult to Flush 16 16
Product Quality Problem 15 15
Off-Label Use 14 14
Material Perforation 14 14
Premature Separation 13 13
Defective Component 12 12
Infusion or Flow Problem 11 11
Difficult or Delayed Positioning 11 11
Collapse 11 11
Delivered as Unsterile Product 10 10
Improper Flow or Infusion 9 9
Difficult to Open or Remove Packaging Material 9 9
Device Handling Problem 9 9
Component Misassembled 9 9
Expulsion 8 8
No Flow 7 7
Material Too Rigid or Stiff 7 7
Material Too Soft/Flexible 7 7
Device Fell 7 7
Unclear Information 6 6
Suction Problem 6 6
Flaked 6 6
Separation Failure 6 6
Malposition of Device 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 7348 7348
No Consequences Or Impact To Patient 3671 3671
No Known Impact Or Consequence To Patient 766 766
Insufficient Information 589 589
Vascular Dissection 455 455
Foreign Body In Patient 370 370
Pericardial Effusion 311 311
Thrombosis/Thrombus 307 307
No Patient Involvement 299 299
Hemorrhage/Bleeding 229 292
Intracranial Hemorrhage 212 275
Hematoma 206 269
Device Embedded In Tissue or Plaque 201 201
Low Blood Pressure/ Hypotension 195 195
Perforation of Vessels 176 176
Stroke/CVA 156 156
Cardiac Perforation 155 155
Cardiac Tamponade 141 141
Obstruction/Occlusion 130 130
Vasoconstriction 128 128
Perforation 115 115
Embolism/Embolus 105 105
Air Embolism 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 91 91
Rupture 87 87
Death 76 76
No Information 75 75
No Code Available 73 73
Thromboembolism 69 69
Unspecified Nervous System Problem 69 69
Ischemia Stroke 67 67
Pseudoaneurysm 67 67
Non specific EKG/ECG Changes 65 65
Cardiac Arrest 63 63
Swelling/ Edema 61 61
Pain 52 52
Myocardial Infarction 52 52
Injury 50 50
Stenosis 49 49
Ischemia 48 48
Embolism 42 42
Aneurysm 39 39
Arrhythmia 36 36
Bradycardia 36 36
Ruptured Aneurysm 36 36
Thrombosis 34 34
Unspecified Infection 30 30
Vessel Or Plaque, Device Embedded In 29 29
Unspecified Tissue Injury 29 29
Blood Loss 27 27
Tachycardia 27 27
Transient Ischemic Attack 27 27
Restenosis 26 26
Occlusion 24 24
Extravasation 23 23
Patient Problem/Medical Problem 20 20
Discomfort 19 19
Fistula 19 19
High Blood Pressure/ Hypertension 19 19
Muscle Weakness 19 19
Thrombus 19 19
Dyspnea 18 18
Chest Pain 18 18
Headache 17 17
Needle Stick/Puncture 16 16
Foreign Body Embolism 15 15
Dysphasia 15 15
Great Vessel Perforation 15 15
Sepsis 15 15
Paralysis 14 14
Paresis 14 14
Ventricular Fibrillation 14 14
Fever 14 14
Cerebral Edema 14 14
Cognitive Changes 13 13
Asystole 13 13
Heart Block 13 13
Heart Failure/Congestive Heart Failure 13 13
Hemorrhagic Stroke 12 12
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
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
Failure of Implant 8 8
Visual Impairment 8 8
Renal Failure 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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