TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2019	196	196
2020	198	198
2021	383	383
2022	477	477
2023	629	629
2024	390	390

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	652	652
Break	419	419
Fluid/Blood Leak	210	210
Defective Component	181	181
Material Separation	173	173
Adverse Event Without Identified Device or Use Problem	111	111
Leak/Splash	97	97
Material Fragmentation	78	78
Infusion or Flow Problem	68	68
Dull, Blunt	54	54
Device Contamination with Chemical or Other Material	47	47
Detachment of Device or Device Component	36	36
Device Contaminated During Manufacture or Shipping	36	36
Disconnection	35	35
Suction Problem	33	33
Unraveled Material	30	30
Difficult to Remove	27	27
Material Integrity Problem	27	27
No Apparent Adverse Event	25	25
Crack	25	25
Contamination /Decontamination Problem	21	21
Obstruction of Flow	19	19
Material Split, Cut or Torn	16	16
Deformation Due to Compressive Stress	15	15
Entrapment of Device	15	15
Suction Failure	14	14
Material Puncture/Hole	13	13
Component Misassembled	12	12
Material Deformation	11	11
Use of Device Problem	10	10
Improper or Incorrect Procedure or Method	9	9
Particulates	9	9
Material Twisted/Bent	9	9
Appropriate Term/Code Not Available	8	8
Physical Resistance/Sticking	8	8
Device Damaged Prior to Use	8	8
Restricted Flow rate	8	8
Migration or Expulsion of Device	7	7
Fitting Problem	7	7
Failure to Advance	6	6
Tear, Rip or Hole in Device Packaging	6	6
Difficult to Insert	6	6
Loose or Intermittent Connection	5	5
Component Missing	5	5
Material Rupture	4	4
Difficult to Flush	4	4
Difficult to Fold, Unfold or Collapse	4	4
Material Frayed	4	4
Decrease in Suction	4	4
Complete Blockage	4	4
Contamination	4	4
Insufficient Information	4	4
Material Protrusion/Extrusion	4	4
Device Dislodged or Dislocated	4	4
Difficult to Advance	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Packaging Problem	3	3
Material Too Soft/Flexible	3	3
Air/Gas in Device	3	3
Migration	3	3
Partial Blockage	3	3
Mechanical Problem	3	3
Misassembled	3	3
Nonstandard Device	3	3
Defective Device	3	3
Malposition of Device	3	3
Patient-Device Incompatibility	2	2
Failure to Infuse	2	2
Connection Problem	2	2
Microbial Contamination of Device	2	2
Unsealed Device Packaging	2	2
Off-Label Use	2	2
Product Quality Problem	2	2
Insufficient Flow or Under Infusion	2	2
Device Slipped	2	2
Incorrect Measurement	2	2
Loss of or Failure to Bond	2	2
Corroded	2	2
Difficult or Delayed Positioning	2	2
Flaked	2	2
Separation Problem	2	2
Illegible Information	2	2
Unclear Information	2	2
Device Handling Problem	2	2
Patient Device Interaction Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Flow	2	2
Device Markings/Labelling Problem	2	2
Gas/Air Leak	2	2
Human-Device Interface Problem	1	1
Expulsion	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Remove Packaging Material	1	1
Unintended Movement	1	1
Positioning Problem	1	1
Optical Distortion	1	1
Output Problem	1	1
Sharp Edges	1	1
Device Fell	1	1
Incomplete or Inadequate Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1565	1565
No Consequences Or Impact To Patient	213	213
Foreign Body In Patient	186	186
No Known Impact Or Consequence To Patient	79	79
Insufficient Information	62	62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	57	57
No Patient Involvement	44	44
Unspecified Infection	31	31
No Code Available	25	25
Device Embedded In Tissue or Plaque	19	19
Hematoma	19	19
Hemorrhage/Bleeding	18	18
Not Applicable	18	18
Failure to Anastomose	17	17
Pneumothorax	17	17
Seroma	16	16
Pain	16	16
Fistula	13	13
Post Operative Wound Infection	12	12
Patient Problem/Medical Problem	9	9
Endophthalmitis	9	9
Bacterial Infection	8	8
Failure of Implant	8	8
Toxic Anterior Segment Syndrome (TASS)	8	8
Wound Dehiscence	7	7
Inflammation	7	7
Abscess	6	6
Pleural Effusion	6	6
Necrosis	6	6
Obstruction/Occlusion	6	6
Sepsis	5	5
Injury	5	5
Cardiac Tamponade	4	4
Uveitis	4	4
Pneumonia	4	4
Hypoxia	4	4
Atrial Fibrillation	4	4
Fever	4	4
Capsular Bag Tear	4	4
No Information	4	4
Unspecified Tissue Injury	4	4
Blood Loss	3	3
Low Oxygen Saturation	3	3
Erythema	3	3
Conjunctivitis	3	3
Low Blood Pressure/ Hypotension	3	3
Abdominal Pain	3	3
Cellulitis	3	3
Impaired Healing	3	3
Vitreous Loss	2	2
Vomiting	2	2
Chills	2	2
Blurred Vision	2	2
Tachycardia	2	2
Scar Tissue	2	2
Urinary Tract Infection	2	2
Paresis	2	2
Nerve Damage	2	2
Internal Organ Perforation	2	2
Septic Shock	2	2
Chest Pain	2	2
Death	2	2
Dehydration	2	2
Dyspnea	2	2
Hypopyon	2	2
Corneal Edema	2	2
Extravasation	2	2
Fluid Discharge	2	2
Swelling/ Edema	1	1
Stenosis of the esophagus	1	1
Angioedema	1	1
Skin Infection	1	1
Skin Inflammation/ Irritation	1	1
Thrombosis/Thrombus	1	1
Respiratory Insufficiency	1	1
Eye Pain	1	1
Intraocular Pressure Decreased	1	1
Respiratory Failure	1	1
Cardiac Perforation	1	1
Confusion/ Disorientation	1	1
Vascular System (Circulation), Impaired	1	1
Pseudoaneurysm	1	1
Post Traumatic Wound Infection	1	1
Tissue Breakdown	1	1
Crushing Injury	1	1
Hemothorax	1	1
Itching Sensation	1	1
Nausea	1	1
Endocarditis	1	1
Cardiac Arrest	1	1
Abnormal Blood Gases	1	1
Adhesion(s)	1	1
Rheumatoid Arthritis	1	1
Asthma	1	1
Shock	1	1
Skin Irritation	1	1
Rash	1	1
Renal Failure	1	1
Respiratory Distress	1	1
Paralysis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	II	May-01-2024
2	Cardinal Health 200, LLC	II	Jan-18-2023
3	Centese Inc.	II	Oct-13-2021
4	Cook Inc.	II	Mar-24-2020
5	Degania Silicone, Ltd.	II	Aug-12-2019
6	Maquet Cardiovascular, LLC	II	Jan-19-2023
7	TELEFLEX MEDICAL INC	II	Mar-24-2021
8	TELEFLEX MEDICAL INC	II	Aug-28-2020