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
Break	10	10
Fracture	10	10
Material Fragmentation	10	10
Detachment of Device or Device Component	8	8
Mechanical Problem	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
Physical Resistance/Sticking	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Retraction Problem	1	1
Material Separation	1	1
Unraveled Material	1	1
Material Perforation	1	1
Material Frayed	1	1
Knotted	1	1
Leak/Splash	1	1
Burst Container or Vessel	1	1
Crack	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
Perforation	2	2
Exposure to Body Fluids	2	2
Death	2	2
No Patient Involvement	2	2
Foreign Body In Patient	1	1
Cardiac Tamponade	1	1
Respiratory Failure	1	1
No Code Available	1	1
Pericardial Effusion	1	1
Insufficient Information	1	1
Electro-Mechanical Dissociation	1	1
Cardiac Arrest	1	1
Ventricular Fibrillation	1	1
Perforation of Vessels	1	1
Air Embolism	1	1
Vascular Dissection	1	1

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