TPLC - Total Product Life Cycle

• Device: biliary catheter for stone removal that may also allow for irrigation and contrast injection
• Regulation Description: Biliary catheter and accessories.
• Product Code: GCA
• Regulation Number: 876.5010
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ANREI MEDICAL (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	8	8
2022	18	18
2023	11	11
2024	14	14
2025	24	24
2026	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	33	33
Deflation Problem	26	26
Adverse Event Without Identified Device or Use Problem	7	7
Improper or Incorrect Procedure or Method	6	6
Leak/Splash	5	5
Failure to Deflate	3	3
Positioning Failure	2	2
Obstruction of Flow	2	2
Material Twisted/Bent	2	2
Migration	2	2
Ejection Problem	1	1
Use of Device Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	60	60
Foreign Body In Patient	7	7
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pancreatitis	2	2
Gastrointestinal Hemorrhage	2	2
Hemorrhage/Bleeding	2	2
Hyperbilirubinemia	1	1
Inflammation	1	1
Pleural Empyema	1	1
Fever	1	1
No Patient Involvement	1	1
Tachycardia	1	1
Thrombocytopenia	1	1
No Consequences Or Impact To Patient	1	1
Fistula	1	1