TPLC - Total Product Life Cycle

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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
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	33	33
Deflation Problem	28	28
Difficult to Remove	27	27
Leak/Splash	11	11
Material Separation	10	10
Difficult to Advance	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Improper or Incorrect Procedure or Method	6	6
Material Fragmentation	4	4
Failure to Deflate	3	3
Device Contaminated During Manufacture or Shipping	2	2
Break	2	2
Positioning Failure	2	2
Obstruction of Flow	2	2
Material Twisted/Bent	2	2
Detachment of Device or Device Component	2	2
Migration	2	2
Fracture	2	2
Burst Container or Vessel	1	1
Physical Resistance/Sticking	1	1
Ejection Problem	1	1
Use of Device Problem	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
No Known Impact Or Consequence To Patient	35	35
No Consequences Or Impact To Patient	16	16
Foreign Body In Patient	9	9
Insufficient Information	5	5
No Patient Involvement	4	4
No Code Available	3	3
Inflammation	3	3
Hemorrhage/Bleeding	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pancreatitis	2	2
Gastrointestinal Hemorrhage	2	2
Hyperbilirubinemia	1	1
Pleural Empyema	1	1
Fever	1	1
Tachycardia	1	1
Thrombocytopenia	1	1
Fistula	1	1