TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2017	176	176
2018	277	277
2019	196	196
2020	198	198
2021	383	383
2022	277	277

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	331	331
Fracture	217	217
Adverse Event Without Identified Device or Use Problem	104	104
Fluid Leak	94	94
Crack	85	85
Leak/Splash	64	64
Material Separation	63	63
Device Contamination with Chemical or Other Material	51	51
Material Fragmentation	46	46
Infusion or Flow Problem	46	46
Dull, Blunt	46	46
Suction Problem	40	40
Appropriate Term/Code Not Available	39	39
Disconnection	31	31
Detachment of Device or Device Component	30	30
No Apparent Adverse Event	25	25
Defective Component	25	25
Device Contaminated During Manufacture or Shipping	24	24
Unraveled Material	24	24
Difficult to Remove	23	23
Contamination /Decontamination Problem	22	22
Entrapment of Device	22	22
Material Split, Cut or Torn	16	16
Detachment Of Device Component	13	13
Material Deformation	12	12
Physical Resistance/Sticking	10	10
Obstruction of Flow	10	10
Kinked	10	10
Misassembled	10	10
Component Misassembled	10	10
Device Markings/Labelling Problem	9	9
Restricted Flow rate	9	9
Use of Device Problem	9	9
Material Puncture/Hole	9	9
Failure to Advance	9	9
Improper or Incorrect Procedure or Method	9	9
Device Operates Differently Than Expected	9	9
Fitting Problem	8	8
Material Integrity Problem	8	8
Particulates	8	8
Material Frayed	8	8
Device Damaged Prior to Use	7	7
Insufficient Information	7	7
Migration or Expulsion of Device	7	7
Material Twisted/Bent	7	7
Inadequacy of Device Shape and/or Size	6	6
Sticking	6	6
Partial Blockage	6	6
Suction Failure	6	6
No Flow	6	6
Packaging Problem	6	6
Mechanical Problem	6	6
Nonstandard Device	6	6
Deformation Due to Compressive Stress	6	6
Defective Device	6	6
Component Missing	5	5
Loose or Intermittent Connection	5	5
Failure to Read Input Signal	5	5
Tear, Rip or Hole in Device Packaging	5	5
Aspiration Issue	5	5
Physical Resistance	5	5
Material Protrusion/Extrusion	4	4
Complete Blockage	4	4
Incorrect Device Or Component Shipped	4	4
Contamination	4	4
Delivered as Unsterile Product	4	4
Occlusion Within Device	4	4
Material Rupture	4	4
Flaked	4	4
Decrease in Suction	4	4
Split	4	4
Incorrect Measurement	4	4
Disassembly	4	4
Collapse	4	4
Device Dislodged or Dislocated	4	4
Torn Material	3	3
Physical Property Issue	3	3
Material Too Soft/Flexible	3	3
Difficult to Insert	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Malposition of Device	3	3
Contamination of Device Ingredient or Reagent	3	3
Bent	3	3
Folded	3	3
Patient-Device Incompatibility	2	2
Patient Device Interaction Problem	2	2
Off-Label Use	2	2
Unclear Information	2	2
Air Leak	2	2
Device Operational Issue	2	2
Device Packaging Compromised	2	2
Material Too Rigid or Stiff	2	2
Separation Failure	2	2
Device Fell	2	2
Corroded	2	2
Difficult to Fold, Unfold or Collapse	2	2
Device Inoperable	2	2
Peeled/Delaminated	2	2
Product Quality Problem	2	2
Failure to Infuse	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	507	507
No Consequences Or Impact To Patient	326	326
No Known Impact Or Consequence To Patient	264	264
Foreign Body In Patient	146	146
No Patient Involvement	86	86
No Code Available	56	56
Not Applicable	48	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	41	41
Device Embedded In Tissue or Plaque	32	32
Unspecified Infection	29	29
Insufficient Information	27	27
No Information	25	25
Pain	21	21
Pneumothorax	19	19
Fistula	18	18
Hematoma	18	18
Failure to Anastomose	17	17
Seroma	15	15
Hemorrhage/Bleeding	14	14
Injury	11	11
Patient Problem/Medical Problem	11	11
Post Operative Wound Infection	9	9
Wound Dehiscence	9	9
Bacterial Infection	8	8
Death	8	8
Blood Loss	8	8
Pleural Effusion	8	8
Abscess	7	7
Inflammation	7	7
Pneumonia	6	6
Obstruction/Occlusion	6	6
Capsular Bag Tear	6	6
Toxic Anterior Segment Syndrome (TASS)	5	5
Sepsis	5	5
Necrosis	5	5
Endophthalmitis	5	5
Erythema	4	4
Fever	4	4
Low Blood Pressure/ Hypotension	4	4
Failure of Implant	4	4
Cardiac Tamponade	4	4
Discomfort	3	3
Impaired Healing	3	3
Hypoxia	3	3
Atrial Fibrillation	3	3
Pericardial Effusion	3	3
Fluid Discharge	2	2
Bowel Perforation	2	2
Dehydration	2	2
Dyspnea	2	2
Cellulitis	2	2
Chest Pain	2	2
Adhesion(s)	2	2
Abdominal Pain	2	2
Hemothorax	2	2
Nerve Damage	2	2
Paralysis	2	2
Paresis	2	2
Vomiting	2	2
Tachycardia	2	2
Tissue Damage	2	2
Urinary Tract Infection	2	2
Vitreous Loss	1	1
Skin Irritation	1	1
Discharge	1	1
Septic Shock	1	1
Rash	1	1
Renal Failure	1	1
Respiratory Distress	1	1
Scar Tissue	1	1
Fasciitis	1	1
Wheal(s)	1	1
Infection, Pyrogenic	1	1
Ulcer	1	1
Pressure Sores	1	1
Pseudoaneurysm	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
Internal Organ Perforation	1	1
Ischemia	1	1
Itching Sensation	1	1
Laceration(s)	1	1
Nausea	1	1
Incontinence	1	1
Abnormal Blood Gases	1	1
Cardiac Arrest	1	1
Cardiopulmonary Arrest	1	1
Crushing Injury	1	1
Extravasation	1	1
Tissue Breakdown	1	1
Nervous System Injury	1	1
Thrombosis/Thrombus	1	1
Respiratory Insufficiency	1	1
Intraocular Pressure Decreased	1	1
Angioedema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	II	Jul-18-2018
2	Cardinal Health 200, LLC	II	May-23-2017
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	Degania Silicone, Ltd.	II	Feb-22-2017
8	TELEFLEX MEDICAL INC	II	Mar-24-2021
9	TELEFLEX MEDICAL INC	II	Aug-28-2020