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	173	173

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	541	541
Break	391	391
Fluid/Blood Leak	188	188
Defective Component	151	151
Material Separation	148	148
Adverse Event Without Identified Device or Use Problem	108	108
Leak/Splash	93	93
Material Fragmentation	74	74
Infusion or Flow Problem	68	68
Dull, Blunt	51	51
Device Contamination with Chemical or Other Material	47	47
Detachment of Device or Device Component	36	36
Device Contaminated During Manufacture or Shipping	34	34
Suction Problem	33	33
Disconnection	33	33
Unraveled Material	27	27
Difficult to Remove	26	26
Crack	25	25
No Apparent Adverse Event	25	25
Contamination /Decontamination Problem	21	21
Material Integrity Problem	20	20
Obstruction of Flow	18	18
Entrapment of Device	15	15
Deformation Due to Compressive Stress	15	15
Material Split, Cut or Torn	15	15
Suction Failure	13	13
Component Misassembled	12	12
Use of Device Problem	10	10
Improper or Incorrect Procedure or Method	9	9
Particulates	9	9
Material Twisted/Bent	9	9
Material Deformation	8	8
Appropriate Term/Code Not Available	8	8
Physical Resistance/Sticking	8	8
Restricted Flow rate	8	8
Migration or Expulsion of Device	7	7
Fitting Problem	7	7
Material Puncture/Hole	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
Material Frayed	4	4
Difficult to Fold, Unfold or Collapse	4	4
Decrease in Suction	4	4
Complete Blockage	4	4
Contamination	4	4
Insufficient Information	4	4
Device Dislodged or Dislocated	4	4
Material Protrusion/Extrusion	4	4
Packaging Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Too Soft/Flexible	3	3
Air/Gas in Device	3	3
Migration	3	3
Misassembled	3	3
Nonstandard Device	3	3
Mechanical Problem	3	3
Device Damaged Prior to Use	3	3
Defective Device	3	3
Malposition of Device	3	3
Difficult to Advance	3	3
Device Markings/Labelling Problem	2	2
Failure to Infuse	2	2
Connection Problem	2	2
Patient-Device Incompatibility	2	2
Product Quality Problem	2	2
Unsealed Device Packaging	2	2
Off-Label Use	2	2
Insufficient Flow or Under Infusion	2	2
Device Slipped	2	2
Corroded	2	2
Partial Blockage	2	2
Loss of or Failure to Bond	2	2
Difficult or Delayed Positioning	2	2
Flaked	2	2
Device Handling Problem	2	2
Patient Device Interaction Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Separation Problem	2	2
Illegible Information	2	2
Unclear Information	2	2
Gas/Air Leak	2	2
No Flow	2	2
Positioning Problem	1	1
Optical Distortion	1	1
Output Problem	1	1
Human-Device Interface Problem	1	1
Expulsion	1	1
Missing Information	1	1
Sharp Edges	1	1
Device Fell	1	1
Incomplete or Inadequate Connection	1	1
Unintended Movement	1	1
Device Contaminated at the User Facility	1	1
Wrong Label	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1372	1372
No Consequences Or Impact To Patient	213	213
Foreign Body In Patient	180	180
No Known Impact Or Consequence To Patient	79	79
Insufficient Information	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	54
No Patient Involvement	44	44
Unspecified Infection	27	27
No Code Available	25	25
Device Embedded In Tissue or Plaque	19	19
Hematoma	19	19
Not Applicable	18	18
Hemorrhage/Bleeding	17	17
Failure to Anastomose	17	17
Pneumothorax	17	17
Seroma	16	16
Pain	16	16
Fistula	13	13
Endophthalmitis	9	9
Patient Problem/Medical Problem	9	9
Toxic Anterior Segment Syndrome (TASS)	8	8
Failure of Implant	8	8
Inflammation	7	7
Wound Dehiscence	7	7
Bacterial Infection	7	7
Post Operative Wound Infection	7	7
Abscess	6	6
Pleural Effusion	6	6
Necrosis	6	6
Sepsis	5	5
Injury	5	5
Obstruction/Occlusion	5	5
Capsular Bag Tear	4	4
No Information	4	4
Cardiac Tamponade	4	4
Uveitis	4	4
Pneumonia	4	4
Hypoxia	4	4
Atrial Fibrillation	4	4
Fever	4	4
Erythema	3	3
Conjunctivitis	3	3
Low Blood Pressure/ Hypotension	3	3
Abdominal Pain	3	3
Cellulitis	3	3
Impaired Healing	3	3
Blood Loss	3	3
Unspecified Tissue Injury	3	3
Fluid Discharge	2	2
Low Oxygen Saturation	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
Crushing Injury	1	1
Extravasation	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
Tissue Damage	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Vitreous Loss	1	1
Respiratory Tract Infection	1	1
Hernia	1	1
Wheal(s)	1	1
Pressure Sores	1	1
Anxiety	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
Swelling/ Edema	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