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TPLC
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show TPLC since
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Device
stent, ureteral
Product Code
FAD
Regulation Number
876.4620
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
SUBSTANTIALLY EQUIVALENT - KIT
3
1. K163399
Tria Firm Ureteral Stent
2. K190603
Tria Firm Ureteral Stent
3. K191609
Tria Soft Ureteral Stent
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT - KIT
2
SUBSTANTIALLY EQUIVALENT
5
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT - KIT
4
SUBSTANTIALLY EQUIVALENT
7
DORNIER MEDTECH AMERICA INC.
SUBSTANTIALLY EQUIVALENT
1
PROMEPLA SAM
SUBSTANTIALLY EQUIVALENT
1
Q UROLOGICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ROCAMED SAM
SUBSTANTIALLY EQUIVALENT
1
URETERAL STENT COMPANY
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
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
688
688
Material Fragmentation
383
383
Calcified
286
286
Adverse Event Without Identified Device or Use Problem
229
229
Difficult to Remove
195
195
Material Split, Cut or Torn
154
154
Material Deformation
133
133
Migration
127
127
Material Separation
127
127
Detachment of Device or Device Component
99
99
Biocompatibility
98
98
Difficult to Advance
96
96
Patient Device Interaction Problem
95
95
Deformation Due to Compressive Stress
84
84
Fracture
67
67
Device Damaged Prior to Use
61
61
Wrong Label
43
43
Device Dislodged or Dislocated
37
37
Obstruction of Flow
37
37
Component Missing
35
35
Material Twisted/Bent
33
33
Partial Blockage
32
32
Use of Device Problem
30
30
Crack
27
27
Difficult to Insert
27
27
Tear, Rip or Hole in Device Packaging
26
26
Material Integrity Problem
24
24
Detachment Of Device Component
24
24
Unsealed Device Packaging
23
23
Off-Label Use
21
21
Torn Material
21
21
Device Contamination with Chemical or Other Material
21
21
Entrapment of Device
20
20
Improper or Incorrect Procedure or Method
19
19
Migration or Expulsion of Device
18
18
Inadequate Instructions for Healthcare Professional
18
18
Accessory Incompatible
18
18
Complete Blockage
17
17
Split
17
17
Appropriate Term/Code Not Available
16
16
Kinked
15
15
Material Too Rigid or Stiff
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
Device Operates Differently Than Expected
12
12
Packaging Problem
12
12
Component Misassembled
12
12
Out-Of-Box Failure
11
11
Stretched
10
10
Knotted
10
10
Flaked
10
10
Inaccurate Flow Rate
10
10
Device Handling Problem
10
10
Insufficient Information
10
10
Device Markings/Labelling Problem
9
9
Defective Device
9
9
Bent
9
9
Peeled/Delaminated
8
8
Activation, Positioning or Separation Problem
8
8
Device-Device Incompatibility
8
8
Positioning Problem
7
7
Physical Resistance/Sticking
7
7
Material Rupture
7
7
Defective Component
6
6
Positioning Failure
6
6
Fluid/Blood Leak
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Patient-Device Incompatibility
6
6
Expiration Date Error
6
6
No Flow
5
5
Activation Failure
5
5
Material Frayed
5
5
Delivered as Unsterile Product
5
5
Disconnection
4
4
Material Disintegration
4
4
Device Fell
4
4
Contamination /Decontamination Problem
4
4
Dent in Material
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Device Operational Issue
3
3
Device Damaged by Another Device
3
3
Device Packaging Compromised
3
3
Structural Problem
3
3
Separation Failure
3
3
Material Too Soft/Flexible
3
3
Missing Information
3
3
No Apparent Adverse Event
3
3
Leak/Splash
3
3
Occlusion Within Device
3
3
Incomplete or Missing Packaging
3
3
Product Quality Problem
3
3
Uncoiled
2
2
Failure to Unfold or Unwrap
2
2
Material Puncture/Hole
2
2
Shipping Damage or Problem
2
2
Material Erosion
2
2
Material Discolored
2
2
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
546
546
No Known Impact Or Consequence To Patient
354
354
No Patient Involvement
173
173
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
147
147
Pain
144
144
Foreign Body In Patient
92
92
No Code Available
73
73
Insufficient Information
67
67
Unspecified Infection
56
56
Urinary Tract Infection
56
56
Hematuria
53
53
Discomfort
47
47
Obstruction/Occlusion
33
33
No Information
30
30
Unspecified Kidney or Urinary Problem
29
29
Device Embedded In Tissue or Plaque
26
26
Hemorrhage/Bleeding
21
21
Micturition Urgency
21
21
Dysuria
20
20
Swelling/ Edema
19
19
Calcium Deposits/Calcification
17
17
Fever
15
15
Fistula
13
13
Sepsis
13
13
Patient Problem/Medical Problem
13
13
Urinary Retention
12
12
Abdominal Pain
12
12
Failure of Implant
11
11
Post Operative Wound Infection
11
11
Urinary Frequency
10
10
Inflammation
9
9
Perforation
9
9
Renal Failure
8
8
Incontinence
6
6
Internal Organ Perforation
6
6
Swelling
5
5
Injury
5
5
Bacterial Infection
5
5
Erosion
4
4
Occlusion
4
4
Nausea
3
3
Hypersensitivity/Allergic reaction
3
3
Irritation
3
3
Exposure to Body Fluids
3
3
Death
3
3
Edema
3
3
Irritability
3
3
Tachycardia
3
3
Urethral Stenosis/Stricture
3
3
Skin Inflammation/ Irritation
3
3
Urinary Incontinence
3
3
Kidney Infection
2
2
Skin Discoloration
2
2
Chills
2
2
Stenosis
2
2
Reaction
2
2
Extravasation
2
2
Dyspnea
2
2
Laceration(s)
2
2
Liver Damage/Dysfunction
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Distress
1
1
Pleural Effusion
1
1
Local Reaction
1
1
Headache
1
1
Hematoma
1
1
Vessel Or Plaque, Device Embedded In
1
1
Abrasion
1
1
Abscess
1
1
Adhesion(s)
1
1
Awareness during Anaesthesia
1
1
Fungal Infection
1
1
Impaired Healing
1
1
Sore Throat
1
1
Respiratory Failure
1
1
Skin Inflammation
1
1
Intraoperative Pain
1
1
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Concussion
1
1
Vomiting
1
1
Burning Sensation
1
1
Urticaria
1
1
Infection, Pyrogenic
1
1
Peritonitis
1
1
Skin Erosion
1
1
Septic Shock
1
1
Shock
1
1
Thrombosis/Thrombus
1
1
Renal Impairment
1
1
Vesicovaginal Fistula
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Skin Infection
1
1
Ascites
1
1
Blood Loss
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Dec-30-2020
2
Cook Inc.
II
Feb-05-2021
3
Cook Inc.
II
Sep-15-2020
4
Cook Inc.
II
Feb-04-2020
5
Hobbs Medical, Inc.
II
Oct-07-2022
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