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Device
stents, drains and dilators for the biliary ducts
Regulation Description
Biliary catheter and accessories.
Product Code
FGE
Regulation Number
876.5010
Device Class
2
Premarket Reviews
Manufacturer
Decision
ASAHI INTECC CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BIOTEQUE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC
SE - WITH LIMITATIONS
2
BOSTON SCIENTIFIC CORPORATION
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
2
COOK IRELAND LTD
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN TT MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDO GI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ENDOGI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ENDOGI MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
SE - WITH LIMITATIONS
1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
LEO MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
M.I.TECH CO., LTD.
SE - WITH LIMITATIONS
1
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
S&G BIOTECH INC.
SE - WITH LIMITATIONS
1
TAEWOONG MEDICAL CO., LTD
SE - WITH LIMITATIONS
2
MDR Year
MDR Reports
MDR Events
2020
2181
2181
2021
2297
2297
2022
1749
1749
2023
1622
1622
2024
1954
1954
2025
468
468
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
2250
2250
Break
1004
1004
Improper or Incorrect Procedure or Method
973
973
Adverse Event Without Identified Device or Use Problem
847
847
Material Puncture/Hole
616
616
Burst Container or Vessel
584
584
Off-Label Use
564
564
Material Deformation
544
544
Detachment of Device or Device Component
440
440
Difficult to Remove
410
410
Migration
370
370
Device Dislodged or Dislocated
343
343
Positioning Failure
300
300
Leak/Splash
286
286
Activation, Positioning or Separation Problem
279
279
Use of Device Problem
278
278
Difficult to Advance
278
278
Material Twisted/Bent
250
250
Activation Failure
230
230
Dent in Material
226
226
Premature Activation
172
172
Fracture
170
170
Inflation Problem
167
167
Failure to Advance
141
141
Difficult or Delayed Positioning
138
138
Entrapment of Device
123
123
Material Integrity Problem
108
108
Material Split, Cut or Torn
96
96
Material Separation
94
94
Obstruction of Flow
85
85
Physical Resistance/Sticking
85
85
Positioning Problem
79
79
Defective Device
72
72
Deformation Due to Compressive Stress
69
69
Deflation Problem
66
66
Crack
59
59
Fluid/Blood Leak
59
59
Mechanical Jam
56
56
Appropriate Term/Code Not Available
54
54
Stretched
54
54
Migration or Expulsion of Device
53
53
Device Damaged Prior to Use
50
50
Defective Component
44
44
Unsealed Device Packaging
43
43
Malposition of Device
43
43
Difficult or Delayed Activation
42
42
Failure to Deflate
41
41
Retraction Problem
38
38
Device-Device Incompatibility
36
36
Difficult to Insert
31
31
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7168
7168
No Consequences Or Impact To Patient
1569
1569
No Known Impact Or Consequence To Patient
442
442
Obstruction/Occlusion
308
308
Insufficient Information
266
266
Perforation
161
161
Foreign Body In Patient
159
159
Inflammation
135
135
Hemorrhage/Bleeding
127
127
Pancreatitis
96
96
Pain
73
73
Abdominal Pain
68
68
Thrombosis/Thrombus
59
59
No Code Available
52
52
Restenosis
49
49
Vascular Dissection
49
49
No Patient Involvement
43
43
Stenosis
42
42
Occlusion
39
39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
36
36
Device Embedded In Tissue or Plaque
35
35
Abscess
34
34
Fever
32
32
Sepsis
30
30
Unspecified Infection
29
29
Hematoma
28
28
Failure of Implant
25
25
Jaundice
24
24
Peritonitis
21
21
Pseudoaneurysm
21
21
Vomiting
20
20
No Information
19
19
Bowel Perforation
18
18
Unspecified Tissue Injury
16
16
Embolism/Embolus
16
16
Thrombosis
14
14
Cardiac Arrest
14
14
Unspecified Hepatic or Biliary Problem
14
14
Discomfort
13
13
Rupture
13
13
Nausea
13
13
Ischemia
12
12
Perforation of Vessels
12
12
Fistula
12
12
Septic Shock
11
11
Injury
11
11
Pneumonia
10
10
Stroke/CVA
10
10
Myocardial Infarction
10
10
Swelling/ Edema
9
9
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Boston Scientific Corporation
II
Dec-01-2021
3
Boston Scientific Corporation
II
Oct-23-2020
4
Boston Scientific Corporation
II
Sep-12-2020
5
Cook Incorporated
II
Jun-27-2024
6
Cook Incorporated
II
Apr-12-2024
7
Cordis Corporation
II
Nov-12-2021
8
Cordis US Corp
II
Jul-11-2022
9
Hobbs Medical, Inc.
II
Oct-07-2022
10
Olympus Corporation of the Americas
II
Oct-25-2024
11
Olympus Corporation of the Americas
II
Jan-31-2024
12
W.L. Gore & Associates, Inc.
II
Feb-22-2024
13
W.L. Gore & Associates, Inc.
II
May-14-2021
14
Wilson-Cook Medical Inc.
II
Dec-01-2023
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