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	29	29

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment Of Device Component	247	247
Break	151	151
Flaked	136	136
Detachment of Device or Device Component	104	104
Adverse Event Without Identified Device or Use Problem	85	85
Device Damaged by Another Device	73	73
Material Integrity Problem	64	64
Material Fragmentation	44	44
Peeled/Delaminated	41	41
Material Deformation	33	33
Unraveled Material	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
Tear, Rip or Hole in Device Packaging	8	8
Use of Device Problem	8	8
Material Separation	7	7
Material Too Rigid or Stiff	7	7
Device Contamination with Chemical or Other Material	7	7
Inadequacy of Device Shape and/or Size	6	6
Bent	6	6
Device Handling Problem	5	5
Device-Device Incompatibility	4	4
Fracture	4	4
Missing Information	4	4
Deformation Due to Compressive Stress	4	4
Incorrect Measurement	3	3
Component Missing	3	3
Appropriate Term/Code Not Available	3	3
Material Frayed	3	3
Product Quality Problem	3	3
Accessory Incompatible	3	3
Device Contaminated During Manufacture or Shipping	3	3
Unsealed Device Packaging	3	3
Sharp Edges	3	3
Defective Device	3	3
Positioning Problem	2	2
Device Packaging Compromised	2	2
Patient Device Interaction Problem	2	2
Off-Label Use	2	2
Improper or Incorrect Procedure or Method	2	2
Device Operates Differently Than Expected	2	2
Component Misassembled	2	2
Contamination /Decontamination Problem	2	2
Activation, Positioning or Separation Problem	2	2
Metal Shedding Debris	1	1
No Apparent Adverse Event	1	1
Structural Problem	1	1
Shipping Damage or Problem	1	1
Material Invagination	1	1
Coiled	1	1
Difficult or Delayed Positioning	1	1
Problem with Sterilization	1	1
Burst Container or Vessel	1	1
Failure to Advance	1	1
Device Fell	1	1
Mechanical Jam	1	1
Out-Of-Box Failure	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Fitting Problem	1	1
Physical Resistance/Sticking	1	1
Biocompatibility	1	1
Component Falling	1	1
Scratched Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Malposition of Device	1	1
Split	1	1
Nonstandard Device	1	1
Failure to Unfold or Unwrap	1	1
Mechanical Problem	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	327	327
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
Death	6	6
Hemorrhage/Bleeding	6	6
Pain	6	6
Inflammation	5	5
Insufficient Information	4	4
Unspecified Infection	3	3
Septic Shock	3	3
Internal Organ Perforation	3	3
Nausea	2	2
Abdominal Pain	2	2
Chills	2	2
Exposure to Body Fluids	2	2
Extravasation	2	2
Fever	2	2
Swelling/ Edema	2	2
Low Blood Pressure/ Hypotension	2	2
Dysuria	1	1
Dyspnea	1	1
Edema	1	1
Disability	1	1
Urinary Tract Infection	1	1
Hypoxia	1	1
Hematuria	1	1
Injury	1	1
Fistula	1	1
Blood Loss	1	1
Cardiac Arrest	1	1
Lethargy	1	1
Test Result	1	1
Laceration(s)	1	1
Swelling	1	1
Thrombosis/Thrombus	1	1
Tissue Damage	1	1
Unspecified Tissue Injury	1	1

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