TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	3
CATHEGENIX (XIAMEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT - KIT	1
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT - KIT	2
	SUBSTANTIALLY EQUIVALENT	1
ROCAMED SAM
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN TRIOUS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
URETERAL STENT COMPANY
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	773	773
Material Fragmentation	575	577
Adverse Event Without Identified Device or Use Problem	328	328
Calcified	302	302
Material Split, Cut or Torn	203	203
Difficult to Advance	200	200
Detachment of Device or Device Component	162	162
Material Deformation	160	160
Migration	156	156
Difficult to Remove	155	155
Deformation Due to Compressive Stress	152	152
Patient Device Interaction Problem	128	128
Material Separation	109	109
Biocompatibility	93	93
Fracture	61	61
Material Twisted/Bent	57	57
Wrong Label	54	54
Nonstandard Device	53	53
Unsealed Device Packaging	42	42
Device Dislodged or Dislocated	38	38
Material Too Rigid or Stiff	38	38
Accessory Incompatible	36	37
Difficult to Insert	35	35
Use of Device Problem	33	33
Material Integrity Problem	32	32
Complete Blockage	31	31
Component Missing	29	29
Partial Blockage	28	28
Premature Separation	28	28
Improper or Incorrect Procedure or Method	27	28
Obstruction of Flow	24	24
Off-Label Use	24	24
Tear, Rip or Hole in Device Packaging	24	24
Device Contamination with Chemical or Other Material	23	23
Component Misassembled	22	22
Device Contaminated During Manufacture or Shipping	22	22
Entrapment of Device	21	21
Device-Device Incompatibility	19	19
Flaked	17	18
Defective Device	17	17
Inadequate Instructions for Healthcare Professional	17	17
Packaging Problem	15	15
Crack	15	16
Separation Failure	14	14
Device Handling Problem	12	12
Device Markings/Labelling Problem	11	11
Peeled/Delaminated	11	11
Migration or Expulsion of Device	11	11
Positioning Problem	11	11
Incorrect Measurement	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2557	2562
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	230	230
No Consequences Or Impact To Patient	189	189
Pain	162	162
Foreign Body In Patient	118	119
Insufficient Information	96	96
No Known Impact Or Consequence To Patient	83	83
Urinary Tract Infection	73	73
Hematuria	69	69
Discomfort	63	63
Unspecified Infection	59	59
No Patient Involvement	46	46
Obstruction/Occlusion	45	45
Unspecified Kidney or Urinary Problem	39	39
Hemorrhage/Bleeding	27	27
Calcium Deposits/Calcification	27	27
Micturition Urgency	27	27
Sepsis	25	25
Dysuria	25	25
No Code Available	24	24
Swelling/ Edema	21	21
Fever	19	19
Abdominal Pain	15	15
Urinary Frequency	15	15
Exposure to Body Fluids	15	15
Urinary Incontinence	14	14
Device Embedded In Tissue or Plaque	12	12
Fistula	12	12
Urinary Retention	11	11
Post Operative Wound Infection	11	11
Perforation	10	10
Vomiting	9	9
Patient Problem/Medical Problem	8	8
Laceration(s)	8	8
Inflammation	8	8
Incontinence	7	7
Skin Inflammation/ Irritation	7	7
Hypersensitivity/Allergic reaction	6	6
Renal Failure	6	6
Internal Organ Perforation	5	5
Erosion	4	4
Abrasion	4	4
Failure of Implant	4	4
Irritability	3	3
Irritation	3	3
Injury	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Bacterial Infection	3	3
Tachycardia	3	3
Urethral Stenosis/Stricture	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Dec-30-2020
2	C.R. Bard Inc	II	Dec-11-2025
3	Cook Inc.	II	Feb-05-2021
4	Cook Inc.	II	Sep-15-2020
5	Cook Inc.	II	Feb-04-2020
6	Hobbs Medical, Inc.	II	Oct-07-2022