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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 183 183

Device Problems MDRs with this Device Problem Events in those MDRs
Break 784 784
Material Fragmentation 399 399
Calcified 317 317
Adverse Event Without Identified Device or Use Problem 252 252
Difficult to Remove 248 248
Material Separation 161 161
Material Split, Cut or Torn 155 155
Material Deformation 140 140
Migration 129 129
Detachment of Device or Device Component 107 107
Difficult to Advance 102 102
Biocompatibility 98 98
Patient Device Interaction Problem 97 97
Deformation Due to Compressive Stress 89 89
Fracture 76 76
Device Damaged Prior to Use 64 64
Wrong Label 44 44
Migration or Expulsion of Device 41 41
Device Dislodged or Dislocated 39 39
Obstruction of Flow 37 37
Knotted 37 37
Partial Blockage 35 35
Component Missing 35 35
Material Twisted/Bent 34 34
Crack 33 33
Torn Material 33 33
Detachment Of Device Component 32 32
Kinked 30 30
Use of Device Problem 30 30
Difficult to Insert 29 29
Tear, Rip or Hole in Device Packaging 28 28
Unsealed Device Packaging 26 26
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
Device Operates Differently Than Expected 20 20
Split 20 20
Accessory Incompatible 19 19
Improper or Incorrect Procedure or Method 19 19
Inadequate Instructions for Healthcare Professional 18 18
Out-Of-Box Failure 18 18
Complete Blockage 18 18
Occlusion Within Device 17 17
Device Contaminated During Manufacture or Shipping 16 16
Material Too Rigid or Stiff 14 14
Insufficient Information 14 14
Packaging Problem 14 14
Component Misassembled 13 13
Incorrect Measurement 13 13
Failure to Advance 13 13
Unraveled Material 12 12
Nonstandard Device 12 12
Stretched 11 11
Defective Device 11 11
Device Handling Problem 11 11
Bent 11 11
Inaccurate Flow Rate 10 10
Positioning Problem 10 10
Flaked 10 10
Device Markings/Labelling Problem 9 9
Disconnection 9 9
Device Packaging Compromised 9 9
Device-Device Incompatibility 9 9
Peeled/Delaminated 9 9
Activation, Positioning or Separation Problem 9 9
Defective Component 8 8
Patient-Device Incompatibility 8 8
Expiration Date Error 7 7
Material Frayed 7 7
Physical Resistance/Sticking 7 7
Material Rupture 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Fluid/Blood Leak 6 6
Positioning Failure 6 6
No Flow 6 6
Activation Failure 5 5
Delivered as Unsterile Product 5 5
Material Disintegration 5 5
Contamination 4 4
Device Fell 4 4
Contamination /Decontamination Problem 4 4
Dent in Material 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Component(s), broken 4 4
Malfunction 4 4
Material Erosion 3 3
Material Too Soft/Flexible 3 3
Inadequacy of Device Shape and/or Size 3 3
Leak/Splash 3 3
Separation Failure 3 3
Incomplete or Missing Packaging 3 3
Device Damaged by Another Device 3 3
No Apparent Adverse Event 3 3
Therapeutic or Diagnostic Output Failure 3 3
Structural Problem 3 3
Material Puncture/Hole 3 3
Product Quality Problem 3 3
Missing Information 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1500 1500
No Consequences Or Impact To Patient 656 656
No Known Impact Or Consequence To Patient 464 464
No Patient Involvement 190 190
Pain 174 174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
No Code Available 131 131
Foreign Body In Patient 98 98
Insufficient Information 69 69
Hematuria 59 59
Unspecified Infection 59 59
Urinary Tract Infection 57 57
Discomfort 50 50
No Information 42 42
Obstruction/Occlusion 36 36
Device Embedded In Tissue or Plaque 33 33
Unspecified Kidney or Urinary Problem 29 29
Calcium Deposits/Calcification 25 25
Urinary Retention 24 24
Hemorrhage/Bleeding 23 23
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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