TPLC - Total Product Life Cycle

• Device: occluder, catheter tip
• Product Code: DQT
• Regulation Number: 870.1370
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	6	6
2016	2	2
2017	4	4
2018	12	12
2019	21	21
2020	11	11
2021	2	2
2022	5	5
2023	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	15	15
Fracture	10	10
Break	10	10
Material Fragmentation	10	10
Mechanical Problem	8	8
Detachment of Device or Device Component	8	8
Material Integrity Problem	6	6
Device Or Device Fragments Location Unknown	4	4
Protective Measures Problem	3	3
Failure to Deflate	2	2
Leak/Splash	1	1
Material Frayed	1	1
Burst Container or Vessel	1	1
Physical Resistance/Sticking	1	1
Crack	1	1
Knotted	1	1
Unraveled Material	1	1
Material Perforation	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	34	34
Device Embedded In Tissue or Plaque	14	14
No Clinical Signs, Symptoms or Conditions	6	6
No Consequences Or Impact To Patient	5	5
Laceration(s)	3	3
Death	2	2
Perforation	2	2
Exposure to Body Fluids	2	2
No Patient Involvement	2	2
Air Embolism	1	1
No Code Available	1	1
Vascular Dissection	1	1
Pericardial Effusion	1	1
Cardiac Arrest	1	1
Electro-Mechanical Dissociation	1	1
Cardiac Tamponade	1	1
Ventricular Fibrillation	1	1
Foreign Body In Patient	1	1
Insufficient Information	1	1
Perforation of Vessels	1	1
Respiratory Failure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Vascular	I	Nov-15-2013