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	478	478

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	320	320
Fracture	233	233
Fluid/Blood Leak	176	176
Adverse Event Without Identified Device or Use Problem	106	106
Leak/Splash	66	66
Crack	61	61
Material Separation	57	57
Infusion or Flow Problem	52	52
Device Contamination with Chemical or Other Material	51	51
Material Fragmentation	49	49
Dull, Blunt	46	46
Defective Component	45	45
Suction Problem	38	38
Appropriate Term/Code Not Available	37	37
Detachment of Device or Device Component	31	31
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	11	11
Obstruction of Flow	10	10
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
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
Tear, Rip or Hole in Device Packaging	6	6
Material Twisted/Bent	6	6
Suction Failure	6	6
Defective Device	5	5
Device Operates Differently Than Expected	5	5
Kinked	5	5
Failure to Read Input Signal	5	5
Material Rupture	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
Flaked	4	4
Device Dislodged or Dislocated	4	4
Material Protrusion/Extrusion	4	4
Insufficient Information	4	4
No Flow	3	3
Packaging Problem	3	3
Material Too Soft/Flexible	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
Difficult to Insert	3	3
Disassembly	3	3
Component Missing	3	3
Sticking	3	3
Device Slipped	2	2
Material Perforation	2	2
Failure to Infuse	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
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
Patient Device Interaction Problem	2	2
Migration	2	2
Positioning Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Torn Material	2	2
Device Fell	2	2
Unclear Information	2	2
Missing Information	1	1
Air/Gas in Device	1	1
Incomplete or Inadequate Connection	1	1
Separation Problem	1	1
Illegible Information	1	1
Physical Property Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	683	683
No Consequences Or Impact To Patient	310	310
No Known Impact Or Consequence To Patient	184	184
Foreign Body In Patient	143	143
No Patient Involvement	73	73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	47	47
Not Applicable	44	44
No Code Available	41	41
Insufficient Information	30	30
Unspecified Infection	25	25
Device Embedded In Tissue or Plaque	23	23
Pneumothorax	19	19
Fistula	18	18
Failure to Anastomose	17	17
Hematoma	16	16
Pain	16	16
Hemorrhage/Bleeding	15	15
Seroma	15	15
No Information	14	14
Patient Problem/Medical Problem	11	11
Injury	9	9
Post Operative Wound Infection	9	9
Wound Dehiscence	9	9
Endophthalmitis	9	9
Inflammation	8	8
Pleural Effusion	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Bacterial Infection	7	7
Abscess	6	6
Pneumonia	6	6
Failure of Implant	6	6
Obstruction/Occlusion	6	6
Capsular Bag Tear	6	6
Blood Loss	6	6
Sepsis	5	5
Death	5	5
Necrosis	5	5
Erythema	4	4
Uveitis	4	4
Impaired Healing	3	3
Cardiac Tamponade	3	3
Conjunctivitis	3	3
Atrial Fibrillation	3	3
Low Blood Pressure/ Hypotension	3	3
Hypoxia	3	3
Fever	2	2
Hemothorax	2	2
Hypopyon	2	2
Nerve Damage	2	2
Corneal Edema	2	2
Cellulitis	2	2
Chest Pain	2	2
Dehydration	2	2
Dyspnea	2	2
Tachycardia	2	2
Vomiting	2	2
Discomfort	2	2
Blurred Vision	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
Pseudoaneurysm	1	1
Tissue Breakdown	1	1
Angioedema	1	1
Swelling/ Edema	1	1
Rash	1	1
Renal Failure	1	1
Respiratory Distress	1	1
Scar Tissue	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Vitreous Loss	1	1
Septic Shock	1	1
Skin Irritation	1	1
Tissue Damage	1	1
Urinary Tract Infection	1	1
Hernia	1	1
Wheal(s)	1	1
Infection, Pyrogenic	1	1
Ulcer	1	1
Pressure Sores	1	1
Fasciitis	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
Extravasation	1	1
Crushing Injury	1	1
Adhesion(s)	1	1
Cardiac Arrest	1	1
Cardiopulmonary Arrest	1	1
Abdominal Pain	1	1
Abnormal Blood Gases	1	1
Internal Organ Perforation	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