TPLC - Total Product Life Cycle

• Device: stent, ureteral
• Product Code: FAD
• Regulation Number: 876.4620
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALLWIN MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
	SUBSTANTIALLY EQUIVALENT - KIT	3
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT - KIT	2
	SUBSTANTIALLY EQUIVALENT	3
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT - KIT	3
	SUBSTANTIALLY EQUIVALENT	4
DORNIER MEDTECH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
PROMEPLA SAM
	SUBSTANTIALLY EQUIVALENT	1
ROCAMED SAM
	SUBSTANTIALLY EQUIVALENT	1
URETERAL STENT COMPANY
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	277	277
2019	261	261
2020	352	352
2021	531	531
2022	559	559
2023	560	560

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	564	564
Material Fragmentation	328	328
Calcified	208	208
Adverse Event Without Identified Device or Use Problem	206	206
Difficult to Remove	143	143
Material Split, Cut or Torn	142	142
Migration	113	113
Material Deformation	113	113
Material Separation	104	104
Biocompatibility	98	98
Detachment of Device or Device Component	88	88
Patient Device Interaction Problem	87	87
Difficult to Advance	84	84
Deformation Due to Compressive Stress	78	78
Fracture	52	52
Device Dislodged or Dislocated	36	36
Wrong Label	35	35
Device Damaged Prior to Use	35	35
Component Missing	33	33
Obstruction of Flow	32	32
Material Twisted/Bent	31	31
Partial Blockage	26	26
Crack	24	24
Tear, Rip or Hole in Device Packaging	24	24
Material Integrity Problem	23	23
Difficult to Insert	22	22
Use of Device Problem	20	20
Off-Label Use	20	20
Improper or Incorrect Procedure or Method	19	19
Unsealed Device Packaging	18	18
Inadequate Instructions for Healthcare Professional	18	18
Device Contamination with Chemical or Other Material	18	18
Torn Material	18	18
Entrapment of Device	17	17
Accessory Incompatible	16	16
Complete Blockage	15	15
Appropriate Term/Code Not Available	15	15
Unraveled Material	12	12
Failure to Advance	11	11
Incorrect Measurement	11	11
Inaccurate Flow Rate	10	10
Material Too Rigid or Stiff	10	10
Device Handling Problem	10	10
Packaging Problem	10	10
Device Contaminated During Manufacture or Shipping	10	10
Defective Device	9	9
Device Markings/Labelling Problem	9	9
Component Misassembled	9	9
Split	9	9
Flaked	9	9
Peeled/Delaminated	8	8
Insufficient Information	8	8
Activation, Positioning or Separation Problem	8	8
Device-Device Incompatibility	8	8
Nonstandard Device	7	7
Positioning Failure	6	6
Material Rupture	6	6
Out-Of-Box Failure	6	6
Expiration Date Error	6	6
Patient-Device Incompatibility	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Physical Resistance/Sticking	6	6
No Flow	5	5
Positioning Problem	5	5
Stretched	5	5
Bent	5	5
Detachment Of Device Component	5	5
Delivered as Unsterile Product	5	5
Migration or Expulsion of Device	5	5
Kinked	4	4
Material Disintegration	4	4
Fluid/Blood Leak	4	4
Material Frayed	4	4
Defective Component	4	4
Activation Failure	4	4
Device Fell	4	4
Contamination /Decontamination Problem	4	4
Device Misassembled During Manufacturing /Shipping	4	4
Device Damaged by Another Device	3	3
Missing Information	3	3
Structural Problem	3	3
Product Quality Problem	3	3
Knotted	3	3
Leak/Splash	3	3
Occlusion Within Device	3	3
Material Erosion	2	2
Disconnection	2	2
Component Incompatible	2	2
Contamination	2	2
Material Puncture/Hole	2	2
Failure to Unfold or Unwrap	2	2
Shipping Damage or Problem	2	2
Dent in Material	2	2
Therapeutic or Diagnostic Output Failure	2	2
Sharp Edges	2	2
Difficult or Delayed Separation	2	2
Premature Separation	2	2
Device Operates Differently Than Expected	2	2
Device Operational Issue	2	2
Malposition of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1260	1260
No Consequences Or Impact To Patient	448	448
No Known Impact Or Consequence To Patient	258	258
No Patient Involvement	141	141
Pain	127	127
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	127	127
Foreign Body In Patient	68	68
No Code Available	62	62
Insufficient Information	57	57
Urinary Tract Infection	52	52
Hematuria	47	47
Unspecified Infection	46	46
Discomfort	39	39
Unspecified Kidney or Urinary Problem	23	23
Obstruction/Occlusion	22	22
Micturition Urgency	21	21
Hemorrhage/Bleeding	21	21
Dysuria	20	20
Swelling/ Edema	19	19
Device Embedded In Tissue or Plaque	17	17
Calcium Deposits/Calcification	16	16
Fever	14	14
Patient Problem/Medical Problem	13	13
No Information	12	12
Urinary Retention	12	12
Fistula	12	12
Failure of Implant	11	11
Abdominal Pain	11	11
Post Operative Wound Infection	11	11
Urinary Frequency	10	10
Sepsis	10	10
Inflammation	9	9
Perforation	9	9
Renal Failure	8	8
Incontinence	6	6
Internal Organ Perforation	6	6
Swelling	5	5
Injury	5	5
Bacterial Infection	5	5
Erosion	4	4
Occlusion	4	4
Nausea	3	3
Irritation	3	3
Edema	3	3
Hypersensitivity/Allergic reaction	3	3
Tachycardia	3	3
Urinary Incontinence	3	3
Urethral Stenosis/Stricture	2	2
Kidney Infection	2	2
Chills	2	2
Stenosis	2	2
Reaction	2	2
Extravasation	2	2
Death	2	2
Dyspnea	2	2
Skin Discoloration	2	2
Skin Erosion	1	1
Shock	1	1
Respiratory Distress	1	1
Laceration(s)	1	1
Liver Damage/Dysfunction	1	1
Pleural Effusion	1	1
Local Reaction	1	1
Abrasion	1	1
Abscess	1	1
Low Blood Pressure/ Hypotension	1	1
Headache	1	1
Hematoma	1	1
Fungal Infection	1	1
Irritability	1	1
Skin Inflammation	1	1
Respiratory Failure	1	1
Ascites	1	1
Blood Loss	1	1
Intraoperative Pain	1	1
Tissue Breakdown	1	1
Alteration In Body Temperature	1	1
Urticaria	1	1
Impaired Healing	1	1
Sore Throat	1	1
Vomiting	1	1
Burning Sensation	1	1
Infection, Pyrogenic	1	1
Thrombosis/Thrombus	1	1
Renal Impairment	1	1
Vesicovaginal Fistula	1	1
Skin Infection	1	1
Skin Inflammation/ Irritation	1	1

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