TPLC - Total Product Life Cycle

• Device: catheter, irrigation
• Product Code: GBX
• Regulation Number: 878.4200
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	277	277
2019	196	196
2020	198	198
2021	383	383
2022	480	480
2023	42	42

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	330	330
Fracture	242	242
Fluid/Blood Leak	182	182
Adverse Event Without Identified Device or Use Problem	108	108
Leak/Splash	68	68
Crack	61	61
Material Separation	59	59
Infusion or Flow Problem	55	55
Device Contamination with Chemical or Other Material	52	52
Material Fragmentation	51	51
Defective Component	47	47
Dull, Blunt	46	46
Suction Problem	38	38
Appropriate Term/Code Not Available	37	37
Detachment of Device or Device Component	33	33
Disconnection	30	30
Device Contaminated During Manufacture or Shipping	25	25
No Apparent Adverse Event	25	25
Contamination /Decontamination Problem	22	22
Entrapment of Device	21	21
Unraveled Material	21	21
Difficult to Remove	20	20
Material Split, Cut or Torn	16	16
Material Deformation	12	12
Use of Device Problem	12	12
Obstruction of Flow	12	12
Misassembled	10	10
Material Integrity Problem	10	10
Physical Resistance/Sticking	10	10
Component Misassembled	10	10
Restricted Flow rate	9	9
Improper or Incorrect Procedure or Method	9	9
Material Puncture/Hole	9	9
Particulates	8	8
Fitting Problem	8	8
Deformation Due to Compressive Stress	8	8
Failure to Advance	7	7
Material Twisted/Bent	7	7
Suction Failure	7	7
Migration or Expulsion of Device	7	7
Material Frayed	6	6
Nonstandard Device	6	6
Loose or Intermittent Connection	6	6
Mechanical Problem	6	6
Partial Blockage	6	6
Defective Device	6	6
Tear, Rip or Hole in Device Packaging	6	6
Device Operates Differently Than Expected	5	5
Kinked	5	5
Failure to Read Input Signal	5	5
Material Rupture	4	4
Component Missing	4	4
Device Damaged Prior to Use	4	4
Complete Blockage	4	4
Decrease in Suction	4	4
Detachment Of Device Component	4	4
Contamination	4	4
Difficult to Insert	4	4
Flaked	4	4
Device Dislodged or Dislocated	4	4
Material Protrusion/Extrusion	4	4
Insufficient Information	4	4
Material Too Soft/Flexible	3	3
No Flow	3	3
Packaging Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Difficult to Advance	3	3
Malposition of Device	3	3
Device Markings/Labelling Problem	3	3
Aspiration Issue	3	3
Collapse	3	3
Disassembly	3	3
Sticking	3	3
Device Slipped	2	2
Failure to Infuse	2	2
Material Perforation	2	2
Unsealed Device Packaging	2	2
Material Too Rigid or Stiff	2	2
Peeled/Delaminated	2	2
Off-Label Use	2	2
Product Quality Problem	2	2
Corroded	2	2
Difficult or Delayed Positioning	2	2
Loss of or Failure to Bond	2	2
Difficult to Fold, Unfold or Collapse	2	2
Delivered as Unsterile Product	2	2
Patient-Device Incompatibility	2	2
Physical Resistance	2	2
Positioning Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Torn Material	2	2
Device Handling Problem	2	2
Patient Device Interaction Problem	2	2
Migration	2	2
Separation Problem	2	2
Illegible Information	2	2
Unclear Information	2	2
Device Fell	2	2
Incomplete or Inadequate Connection	1	1
Sharp Edges	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	716	716
No Consequences Or Impact To Patient	310	310
No Known Impact Or Consequence To Patient	184	184
Foreign Body In Patient	148	148
No Patient Involvement	73	73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	48	48
Not Applicable	44	44
No Code Available	41	41
Insufficient Information	30	30
Unspecified Infection	26	26
Device Embedded In Tissue or Plaque	23	23
Pneumothorax	19	19
Fistula	18	18
Hematoma	18	18
Failure to Anastomose	17	17
Pain	16	16
Seroma	16	16
Hemorrhage/Bleeding	15	15
No Information	14	14
Patient Problem/Medical Problem	11	11
Post Operative Wound Infection	9	9
Endophthalmitis	9	9
Wound Dehiscence	9	9
Injury	9	9
Pleural Effusion	8	8
Bacterial Infection	8	8
Inflammation	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Blood Loss	6	6
Capsular Bag Tear	6	6
Abscess	6	6
Pneumonia	6	6
Failure of Implant	6	6
Obstruction/Occlusion	6	6
Sepsis	5	5
Death	5	5
Necrosis	5	5
Erythema	4	4
Uveitis	4	4
Cardiac Tamponade	3	3
Impaired Healing	3	3
Atrial Fibrillation	3	3
Low Blood Pressure/ Hypotension	3	3
Hypoxia	3	3
Conjunctivitis	3	3
Corneal Edema	2	2
Dehydration	2	2
Dyspnea	2	2
Cellulitis	2	2
Chest Pain	2	2
Nerve Damage	2	2
Internal Organ Perforation	2	2
Fever	2	2
Hemothorax	2	2
Hypopyon	2	2
Vomiting	2	2
Discomfort	2	2
Blurred Vision	2	2
Tachycardia	2	2
Paresis	2	2
Fluid Discharge	2	2
Pericardial Effusion	2	2
Thrombosis/Thrombus	1	1
Respiratory Insufficiency	1	1
Eye Pain	1	1
Intraocular Pressure Decreased	1	1
Stenosis of the esophagus	1	1
Angioedema	1	1
Swelling/ Edema	1	1
Pseudoaneurysm	1	1
Tissue Breakdown	1	1
Post Traumatic Wound Infection	1	1
Low Oxygen Saturation	1	1
Cardiac Perforation	1	1
Eye Burn	1	1
Confusion/ Disorientation	1	1
Vascular System (Circulation), Impaired	1	1
Paralysis	1	1
Rash	1	1
Renal Failure	1	1
Respiratory Distress	1	1
Scar Tissue	1	1
Tissue Damage	1	1
Urinary Tract Infection	1	1
Skin Irritation	1	1
Septic Shock	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Vitreous Loss	1	1
Hernia	1	1
Wheal(s)	1	1
Infection, Pyrogenic	1	1
Ulcer	1	1
Pressure Sores	1	1
Anxiety	1	1
Rupture	1	1
Fasciitis	1	1
Extravasation	1	1
Ischemia	1	1
Itching Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	II	Jan-18-2023
2	Cardinal Health 200, LLC	II	Jul-18-2018
3	Centese Inc.	II	Oct-13-2021
4	Cook Inc.	II	Mar-24-2020
5	Degania Silicone, Ltd.	II	Aug-12-2019
6	Degania Silicone, Ltd.	III	Feb-20-2018
7	Maquet Cardiovascular, LLC	II	Jan-19-2023
8	TELEFLEX MEDICAL INC	II	Mar-24-2021
9	TELEFLEX MEDICAL INC	II	Aug-28-2020