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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, ureteral
Product CodeFAD
Regulation Number 876.4620
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - KIT 3
BRIGHTWATER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 5
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 4
  SUBSTANTIALLY EQUIVALENT 9
DORNIER MEDTECH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEPLA SAM
  SUBSTANTIALLY EQUIVALENT 1
Q UROLOGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ROCAMED SAM
  SUBSTANTIALLY EQUIVALENT 1
URETERAL STENT COMPANY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 78 78
2015 130 130
2016 182 182
2017 265 265
2018 277 277
2019 261 261
2020 352 352
2021 531 531
2022 559 559
2023 691 691
2024 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Break 777 777
Material Fragmentation 387 387
Calcified 311 311
Adverse Event Without Identified Device or Use Problem 252 252
Difficult to Remove 248 248
Material Separation 161 161
Material Split, Cut or Torn 154 154
Material Deformation 139 139
Migration 127 127
Detachment of Device or Device Component 105 105
Biocompatibility 98 98
Difficult to Advance 97 97
Patient Device Interaction Problem 95 95
Deformation Due to Compressive Stress 85 85
Fracture 76 76
Device Damaged Prior to Use 64 64
Wrong Label 43 43
Migration or Expulsion of Device 41 41
Device Dislodged or Dislocated 39 39
Obstruction of Flow 37 37
Knotted 37 37
Component Missing 35 35
Partial Blockage 34 34
Crack 33 33
Material Twisted/Bent 33 33
Torn Material 33 33
Detachment Of Device Component 32 32
Kinked 30 30
Use of Device Problem 30 30
Difficult to Insert 28 28
Tear, Rip or Hole in Device Packaging 28 28
Unsealed Device Packaging 25 25
Material Integrity Problem 24 24
Device Contamination with Chemical or Other Material 23 23
Entrapment of Device 23 23
Off-Label Use 21 21
Appropriate Term/Code Not Available 21 21
Split 20 20
Device Operates Differently Than Expected 20 20
Improper or Incorrect Procedure or Method 19 19
Inadequate Instructions for Healthcare Professional 18 18
Accessory Incompatible 18 18
Complete Blockage 18 18
Out-Of-Box Failure 18 18
Occlusion Within Device 17 17
Material Too Rigid or Stiff 14 14
Insufficient Information 14 14
Packaging Problem 14 14
Device Contaminated During Manufacture or Shipping 14 14
Failure to Advance 13 13
Incorrect Measurement 13 13
Nonstandard Device 12 12
Unraveled Material 12 12
Component Misassembled 12 12
Defective Device 11 11
Stretched 11 11
Bent 11 11
Flaked 10 10
Inaccurate Flow Rate 10 10
Device Handling Problem 10 10
Positioning Problem 9 9
Device Packaging Compromised 9 9
Device Markings/Labelling Problem 9 9
Activation, Positioning or Separation Problem 9 9
Disconnection 9 9
Peeled/Delaminated 9 9
Defective Component 8 8
Patient-Device Incompatibility 8 8
Device-Device Incompatibility 8 8
Expiration Date Error 7 7
Physical Resistance/Sticking 7 7
Material Rupture 7 7
Material Frayed 7 7
Fluid/Blood Leak 6 6
Positioning Failure 6 6
Manufacturing, Packaging or Shipping Problem 6 6
No Flow 6 6
Activation Failure 5 5
Material Disintegration 5 5
Delivered as Unsterile Product 5 5
Contamination 4 4
Component(s), broken 4 4
Device Fell 4 4
Contamination /Decontamination Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Dent in Material 4 4
Malfunction 4 4
Incomplete or Missing Packaging 3 3
Structural Problem 3 3
Separation Failure 3 3
Device Operational Issue 3 3
Device Damaged by Another Device 3 3
Material Too Soft/Flexible 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Material Erosion 3 3
Leak/Splash 3 3
Product Quality Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Missing Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1465 1465
No Consequences Or Impact To Patient 656 656
No Known Impact Or Consequence To Patient 464 464
No Patient Involvement 190 190
Pain 170 170
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 147 147
No Code Available 131 131
Foreign Body In Patient 98 98
Insufficient Information 67 67
Unspecified Infection 59 59
Hematuria 58 58
Urinary Tract Infection 57 57
Discomfort 49 49
No Information 42 42
Obstruction/Occlusion 35 35
Device Embedded In Tissue or Plaque 33 33
Unspecified Kidney or Urinary Problem 29 29
Urinary Retention 24 24
Calcium Deposits/Calcification 23 23
Hemorrhage/Bleeding 22 22
Micturition Urgency 21 21
Dysuria 20 20
Swelling/ Edema 19 19
Fever 17 17
Abdominal Pain 14 14
Patient Problem/Medical Problem 14 14
Surgical procedure, additional 13 13
Fistula 13 13
Sepsis 13 13
Post Operative Wound Infection 11 11
Foreign body, removal of 11 11
Urinary Frequency 11 11
Failure of Implant 11 11
Perforation 10 10
Occlusion 9 9
Inflammation 9 9
Renal Failure 9 9
Swelling 8 8
Injury 7 7
Internal Organ Perforation 6 6
Incontinence 6 6
Erosion 5 5
Death 5 5
Bacterial Infection 5 5
Exposure to Body Fluids 3 3
Edema 3 3
Foreign Body Reaction 3 3
Hematoma 3 3
Hypersensitivity/Allergic reaction 3 3
Irritation 3 3
Tachycardia 3 3
Nausea 3 3
Other (for use when an appropriate patient code cannot be identified) 3 3
Irritability 3 3
Skin Inflammation/ Irritation 3 3
Urinary Incontinence 3 3
Urethral Stenosis/Stricture 3 3
Kidney Infection 2 2
Vomiting 2 2
Skin Discoloration 2 2
Stenosis 2 2
Chills 2 2
Reaction 2 2
Laceration(s) 2 2
Extravasation 2 2
Dyspnea 2 2
Vessel Or Plaque, Device Embedded In 2 2
Bleeding 1 1
Abrasion 1 1
Abscess 1 1
Adhesion(s) 1 1
Anemia 1 1
Awareness during Anaesthesia 1 1
Headache 1 1
Liver Damage/Dysfunction 1 1
Low Blood Pressure/ Hypotension 1 1
Pleural Effusion 1 1
Local Reaction 1 1
Fungal Infection 1 1
Impaired Healing 1 1
Sore Throat 1 1
Respiratory Failure 1 1
Skin Inflammation 1 1
Concussion 1 1
Nonresorbable materials, unretrieved in body 1 1
Urticaria 1 1
Blockage 1 1
Skin Erosion 1 1
Surgical procedure, repeated 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Shock 1 1
Burning Sensation 1 1
Unknown (for use when the patient's condition is not known) 1 1
Infection, Pyrogenic 1 1
Migration 1 1
Peritonitis 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Vesicovaginal Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-30-2020
2 Boston Scientific Corporation II May-21-2009
3 C.R. Bard, Inc. II Nov-14-2016
4 Cook Inc. II Feb-05-2021
5 Cook Inc. II Sep-15-2020
6 Cook Inc. II Feb-04-2020
7 Hobbs Medical, Inc. II Oct-07-2022
8 Vance Products Incorporated II Jun-25-2015
9 Vance Products Incorporated II Jan-05-2011
10 Vance Products Incorporated II Feb-10-2009
11 Vance Products Incorporated II Jan-23-2009
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