TPLC - Total Product Life Cycle

• Device: stylet for catheter, gastro-urology
• Product Code: EZB
• Regulation Number: 876.5130
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	215	215
2015	53	53
2016	74	74
2017	58	58
2018	46	46
2019	65	65
2020	65	65
2021	69	69
2022	103	103
2023	179	179
2024	38	38

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment Of Device Component	247	247
Break	153	153
Flaked	136	136
Detachment of Device or Device Component	109	109
Adverse Event Without Identified Device or Use Problem	87	87
Device Damaged by Another Device	73	73
Material Integrity Problem	64	64
Material Fragmentation	44	44
Peeled/Delaminated	43	43
Unraveled Material	33	33
Material Deformation	33	33
Material Protrusion/Extrusion	29	29
Difficult to Advance	18	18
Material Twisted/Bent	17	17
Improper Chemical Reaction	16	16
Entrapment of Device	13	13
Difficult to Insert	12	12
Difficult to Remove	10	10
Device Damaged Prior to Use	9	9
Use of Device Problem	8	8
Tear, Rip or Hole in Device Packaging	8	8
Device Contamination with Chemical or Other Material	7	7
Material Too Rigid or Stiff	7	7
Material Separation	7	7
Inadequacy of Device Shape and/or Size	6	6
Bent	6	6
Device Handling Problem	5	5
Device-Device Incompatibility	4	4
Deformation Due to Compressive Stress	4	4
Fracture	4	4
Missing Information	4	4
Appropriate Term/Code Not Available	3	3
Sharp Edges	3	3
Accessory Incompatible	3	3
Material Frayed	3	3
Unsealed Device Packaging	3	3
Incorrect Measurement	3	3
Component Missing	3	3
Defective Device	3	3
Product Quality Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Patient Device Interaction Problem	2	2
Component Misassembled	2	2
Positioning Problem	2	2
Device Operates Differently Than Expected	2	2
Device Packaging Compromised	2	2
Contamination /Decontamination Problem	2	2
Activation, Positioning or Separation Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Off-Label Use	2	2
Problem with Sterilization	1	1
Shipping Damage or Problem	1	1
Fitting Problem	1	1
Out-Of-Box Failure	1	1
Metal Shedding Debris	1	1
Failure to Unfold or Unwrap	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1
Material Invagination	1	1
Burst Container or Vessel	1	1
Coiled	1	1
Component Falling	1	1
Difficult or Delayed Positioning	1	1
Malposition of Device	1	1
Biocompatibility	1	1
Structural Problem	1	1
Failure to Advance	1	1
Split	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Scratched Material	1	1
No Apparent Adverse Event	1	1
Physical Resistance/Sticking	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Mechanical Jam	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	402	402
No Clinical Signs, Symptoms or Conditions	335	335
No Known Impact Or Consequence To Patient	93	93
No Patient Involvement	34	34
Foreign Body In Patient	29	29
Device Embedded In Tissue or Plaque	23	23
Perforation	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
No Information	15	15
No Code Available	7	7
Hemorrhage/Bleeding	7	7
Death	6	6
Pain	6	6
Inflammation	5	5
Unspecified Infection	4	4
Insufficient Information	4	4
Septic Shock	3	3
Internal Organ Perforation	3	3
Hematuria	2	2
Chills	2	2
Nausea	2	2
Abdominal Pain	2	2
Exposure to Body Fluids	2	2
Low Blood Pressure/ Hypotension	2	2
Extravasation	2	2
Fever	2	2
Swelling/ Edema	2	2
Fistula	1	1
Hypoxia	1	1
Cardiac Arrest	1	1
Dyspnea	1	1
Edema	1	1
Laceration(s)	1	1
Swelling	1	1
Tissue Damage	1	1
Urinary Tract Infection	1	1
Test Result	1	1
Thrombosis/Thrombus	1	1
Unspecified Tissue Injury	1	1
Lethargy	1	1
Blood Loss	1	1
Dysuria	1	1
Injury	1	1
Disability	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific	II	Apr-01-2020