TPLC - Total Product Life Cycle

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Device	dislodger, stone, biliary
Regulation Description	Biliary catheter and accessories.
Product Code	LQR
Regulation Number	876.5010
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	118	118
Difficult to Fold, Unfold or Collapse	68	68
Fracture	62	62
Adverse Event Without Identified Device or Use Problem	49	49
Material Separation	46	46
Detachment of Device or Device Component	23	23
Difficult to Open or Close	22	22
Material Deformation	19	19
Difficult to Remove	16	16
Material Split, Cut or Torn	15	15
Material Rupture	15	15
Entrapment of Device	13	13
Positioning Problem	11	11
Defective Device	8	8
Deformation Due to Compressive Stress	7	7
Mechanical Jam	6	6
Failure to Fold	6	6
Failure to Deflate	5	5
Material Twisted/Bent	5	5
Mechanical Problem	5	5
Difficult to Advance	4	4
Failure to Advance	4	4
Deflation Problem	3	3
Retraction Problem	3	3
Use of Device Problem	2	2
Obstruction of Flow	2	2
Difficult or Delayed Activation	2	2
Failure to Conduct	2	2
Burst Container or Vessel	2	2
Failure to Deliver	1	1
Component Missing	1	1
Failure to Align	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Unintended Movement	1	1
Misassembled	1	1
Separation Failure	1	1
Product Quality Problem	1	1
Collapse	1	1
Tear, Rip or Hole in Device Packaging	1	1
Activation Problem	1	1
Physical Resistance/Sticking	1	1
Device Dislodged or Dislocated	1	1
Off-Label Use	1	1
Firing Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	361	361
Foreign Body In Patient	20	20
Pancreatitis	9	9
Perforation	5	5
Insufficient Information	5	5
No Consequences Or Impact To Patient	4	4
Peritonitis	3	3
Unspecified Hepatic or Biliary Problem	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Hypoxia	2	2
Device Embedded In Tissue or Plaque	2	2
Gastrointestinal Hemorrhage	2	2
Perforation of Esophagus	2	2
No Patient Involvement	2	2
Bowel Perforation	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Cholangitis	1	1
Intraoperative Pain	1	1
Inflammation	1	1
Necrosis	1	1
Jaundice	1	1
Abdominal Pain	1	1
Erosion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Incorporated	II	Apr-06-2026