TPLC - Total Product Life Cycle

• Device: catheter, nephrostomy
• Product Code: LJE
• Device Class: Unclassified

Premarket Reviews
Manufacturer	Decision
COLOPLAST CORP
	SUBSTANTIALLY EQUIVALENT - KIT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	4
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	78	78
2020	50	50
2021	38	38
2022	42	42
2023	132	132
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	63	63
Adverse Event Without Identified Device or Use Problem	59	59
Fluid/Blood Leak	27	27
Break	23	23
Material Rupture	20	20
Difficult to Remove	18	18
Fracture	17	17
Material Separation	15	15
Leak/Splash	13	13
Material Deformation	13	13
Difficult to Advance	12	12
Material Split, Cut or Torn	11	11
Device Contamination with Chemical or Other Material	10	10
Inflation Problem	10	10
Material Puncture/Hole	10	10
Detachment of Device or Device Component	9	9
Use of Device Problem	7	7
Material Fragmentation	7	7
Nonstandard Device	5	5
Material Integrity Problem	5	5
Material Twisted/Bent	5	5
Obstruction of Flow	5	5
Defective Device	4	4
Stretched	4	4
Entrapment of Device	3	3
Crack	3	3
Deflation Problem	3	3
Appropriate Term/Code Not Available	3	3
Device Handling Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Deformation Due to Compressive Stress	2	2
Tear, Rip or Hole in Device Packaging	2	2
Separation Failure	2	2
Difficult to Open or Remove Packaging Material	2	2
Positioning Failure	2	2
Complete Blockage	2	2
Difficult to Insert	2	2
Component Missing	2	2
Unsealed Device Packaging	2	2
Product Quality Problem	2	2
Retraction Problem	1	1
Peeled/Delaminated	1	1
Decrease in Pressure	1	1
Failure to Infuse	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Unraveled Material	1	1
Inadequate Instructions for Healthcare Professional	1	1
Mechanical Problem	1	1
Unintended Ejection	1	1
Component Incompatible	1	1
Contamination	1	1
Accessory Incompatible	1	1
Failure to Capture	1	1
Device Dislodged or Dislocated	1	1
Gas/Air Leak	1	1
Compatibility Problem	1	1
Mechanical Jam	1	1
No Flow	1	1
Failure to Advance	1	1
Connection Problem	1	1
Difficult to Open or Close	1	1
Therapeutic or Diagnostic Output Failure	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	146	146
No Consequences Or Impact To Patient	69	69
No Known Impact Or Consequence To Patient	50	50
No Code Available	18	18
Hemorrhage/Bleeding	15	15
Sepsis	12	12
Obstruction/Occlusion	10	10
Insufficient Information	10	10
Renal Failure	7	7
Urinary Tract Infection	6	6
No Patient Involvement	6	6
Foreign Body In Patient	6	6
Septic Shock	5	5
Hematuria	4	4
Pain	4	4
Perforation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Device Embedded In Tissue or Plaque	3	3
Pseudoaneurysm	3	3
Post Operative Wound Infection	2	2
Respiratory Failure	2	2
Hematoma	2	2
Pleural Effusion	2	2
Pneumonia	2	2
Pneumothorax	2	2
Failure of Implant	2	2
Abscess	2	2
Cardiac Arrest	1	1
Deposits	1	1
Purulent Discharge	1	1
Fever	1	1
Fistula	1	1
Hemothorax	1	1
Hypovolemic Shock	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1
Unspecified Infection	1	1
Liver Damage/Dysfunction	1	1
Internal Organ Perforation	1	1
Perforation of Vessels	1	1
Transient Ischemic Attack	1	1
Urinary Retention	1	1
Anxiety	1	1
Bowel Perforation	1	1
Fluid Discharge	1	1
No Information	1	1
Respiratory Insufficiency	1	1
Unspecified Kidney or Urinary Problem	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Dec-22-2021
2	Cook Inc.	II	Oct-14-2020
3	Cook Inc.	II	Feb-04-2020