TPLC - Total Product Life Cycle

• Device: stabilizer, heart
• Product Code: MWS
• Regulation Number: 870.4500
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	34	34
2015	66	66
2016	52	52
2017	45	45
2018	52	52
2019	57	57
2020	43	43
2021	74	74
2022	98	98
2023	67	67
2024	18	18

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	133	133
Mechanical Problem	113	113
Positioning Failure	60	60
Suction Problem	28	28
Positioning Problem	27	27
Component Missing	25	25
Device Operates Differently Than Expected	23	23
Loose or Intermittent Connection	19	19
Mechanics Altered	18	18
Detachment of Device or Device Component	16	16
Detachment Of Device Component	15	15
Suction Failure	14	14
Physical Resistance/Sticking	12	12
Defective Component	11	11
Material Deformation	10	10
Insufficient Information	9	9
Use of Device Problem	9	9
Device Slipped	8	8
Material Too Rigid or Stiff	8	8
Packaging Problem	8	8
Adverse Event Without Identified Device or Use Problem	7	7
Unstable	7	7
Device Damaged Prior to Use	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Material Separation	6	6
Device Inoperable	6	6
Decrease in Suction	5	5
Defective Device	5	5
Connection Problem	4	4
Incomplete or Missing Packaging	3	3
Material Too Soft/Flexible	3	3
Pressure Problem	3	3
Unintended Movement	3	3
Fracture	3	3
Difficult To Position	3	3
Device Difficult to Setup or Prepare	2	2
Inadequacy of Device Shape and/or Size	2	2
Improper or Incorrect Procedure or Method	2	2
Fitting Problem	2	2
Unintended System Motion	2	2
Crack	2	2
Component Falling	2	2
Torn Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Activation, Positioning or Separation Problem	2	2
Device Packaging Compromised	2	2
Illegible Information	2	2
Device Fell	1	1
Incomplete or Inadequate Connection	1	1
Activation Problem	1	1
Misassembled During Installation	1	1
Device Dislodged or Dislocated	1	1
Environmental Particulates	1	1
Device Damaged by Another Device	1	1
Device Contamination With Biological Material	1	1
Structural Problem	1	1
Aspiration Issue	1	1
Contamination /Decontamination Problem	1	1
No Apparent Adverse Event	1	1
Noise, Audible	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Mechanical Jam	1	1
Power Problem	1	1
Contamination	1	1
Burst Container or Vessel	1	1
Collapse	1	1
Failure To Adhere Or Bond	1	1
Loss of or Failure to Bond	1	1
Poor Quality Image	1	1
Nonstandard Device	1	1
Material Fragmentation	1	1
Material Frayed	1	1
Sticking	1	1
Device Difficult to Program or Calibrate	1	1
Power Conditioning Problem	1	1
Inadequate Service	1	1
Shipping Damage or Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	231	231
No Known Impact Or Consequence To Patient	174	174
No Consequences Or Impact To Patient	110	110
No Patient Involvement	41	41
Insufficient Information	24	24
No Information	20	20
Foreign Body In Patient	6	6
Hematoma	5	5
Tissue Damage	3	3
Blood Loss	3	3
Injury	2	2
Bradycardia	2	2
High Blood Pressure/ Hypertension	2	2
Low Blood Pressure/ Hypotension	2	2
Ischemia	1	1
Myocardial Infarction	1	1
Perforation	1	1
Stroke/CVA	1	1
Death	1	1
Non specific EKG/ECG Changes	1	1
Foreign Body Sensation in Eye	1	1
Post Operative Wound Infection	1	1
Rupture	1	1
Ventricular Fibrillation	1	1
Hemorrhage/Bleeding	1	1
Abrasion	1	1
Patient Problem/Medical Problem	1	1
No Code Available	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Maquet Cardiovascular, LLC	II	Dec-19-2023
2	Maquet Cardiovascular, LLC	II	Oct-22-2023
3	Maquet Cardiovascular, LLC	II	Oct-24-2014
4	Maquet Cardiovascular, LLC	II	Feb-06-2012
5	Terumo Cardiovascular Systems Corporation	II	Apr-06-2021
6	Terumo Cardiovascular Systems Corporation	II	Feb-22-2017
7	Terumo Cardiovascular Systems Corporation	II	Feb-14-2017