TPLC - Total Product Life Cycle

show TPLC since

Device	stylet for catheter, gastro-urology
Regulation Description	Urological catheter and accessories.
Product Code	EZB
Regulation Number	876.5130
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Flaked	162	163
Adverse Event Without Identified Device or Use Problem	139	139
Detachment of Device or Device Component	126	126
Break	83	83
Material Fragmentation	58	59
Peeled/Delaminated	50	50
Material Protrusion/Extrusion	31	31
Difficult to Advance	27	27
Improper Chemical Reaction	24	24
Unraveled Material	24	24
Material Twisted/Bent	22	23
Material Deformation	13	13
Material Integrity Problem	13	13
Difficult to Insert	12	13
Entrapment of Device	11	11
Device-Device Incompatibility	9	9
Device Contamination with Chemical or Other Material	9	9
Accessory Incompatible	8	8
Use of Device Problem	8	8
Difficult to Remove	8	8
Deformation Due to Compressive Stress	6	7
Device Damaged by Another Device	6	6
Inadequacy of Device Shape and/or Size	6	6
Tear, Rip or Hole in Device Packaging	6	6
Defective Device	6	6
Device Handling Problem	5	5
Material Too Rigid or Stiff	5	5
Missing Information	5	5
Material Split, Cut or Torn	5	5
Material Separation	4	4
Nonstandard Device	4	4
Sharp Edges	4	4
Unsealed Device Packaging	3	3
Component Misassembled	3	3
Appropriate Term/Code Not Available	3	3
Incorrect Measurement	3	3
Patient Device Interaction Problem	2	2
Scratched Material	2	2
Contamination /Decontamination Problem	2	2
Failure to Advance	2	2
Device Contaminated During Manufacture or Shipping	2	2
Failure to Unfold or Unwrap	1	1
Material Too Soft/Flexible	1	1
Biocompatibility	1	1
Problem with Sterilization	1	1
Component Missing	1	1
Positioning Failure	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Shipping Damage or Problem	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	478	482
No Consequences Or Impact To Patient	41	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	40
Foreign Body In Patient	28	28
Fever	18	18
No Known Impact Or Consequence To Patient	17	17
Insufficient Information	17	17
Perforation	16	16
No Patient Involvement	16	16
Hemorrhage/Bleeding	14	14
Exposure to Body Fluids	14	14
Hematuria	13	13
Pain	12	12
Sepsis	9	9
Laceration(s)	9	9
Urinary Tract Infection	9	9
Unspecified Infection	8	8
Unspecified Tissue Injury	7	7
Hematoma	6	6
Device Embedded In Tissue or Plaque	5	5
Renal Failure	4	4
Low Blood Pressure/ Hypotension	4	4
Septic Shock	4	4
Thrombosis/Thrombus	3	3
Obstruction/Occlusion	3	3
Discomfort	3	3
Urinary Incontinence	3	3
Nausea	3	3
Chills	2	2
Cardiac Arrest	2	2
Multiple Organ Failure	2	2
Pleural Effusion	2	2
Anemia	2	2
Extravasation	2	2
Pancreatitis	2	2
Swelling/ Edema	2	2
Abdominal Pain	2	2
Ischemia Stroke	1	1
Deformity/ Disfigurement	1	1
Lethargy	1	1
Fistula	1	1
Myocardial Infarction	1	1
Tissue Damage	1	1
Asystole	1	1
Abscess	1	1
Prolapse	1	1
Vomiting	1	1
Urinary Retention	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Injury	1	1

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