TPLC - Total Product Life Cycle

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Device	syringe, balloon inflation
Regulation Description	Angiographic injector and syringe.
Product Code	MAV
Regulation Number	870.1650
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	939	939
Loose or Intermittent Connection	200	200
Display or Visual Feedback Problem	145	147
Break	76	76
Physical Resistance/Sticking	45	45
Incorrect, Inadequate or Imprecise Result or Readings	43	44
Device Contamination with Chemical or Other Material	38	38
Inflation Problem	31	31
Unsealed Device Packaging	25	25
Packaging Problem	18	18
Deflation Problem	16	16
Material Separation	15	15
Tear, Rip or Hole in Device Packaging	13	13
Improper or Incorrect Procedure or Method	12	12
Detachment of Device or Device Component	9	9
Contamination	9	9
Material Integrity Problem	7	7
Noise, Audible	6	6
Device Damaged Prior to Receipt by User	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Decoupling	5	5
Product Quality Problem	5	5
Difficult to Open or Remove Packaging Material	5	5
Device Contaminated During Manufacture or Shipping	5	5
Failure to Zero	4	4
Mechanical Problem	4	4
Obstruction of Flow	3	3
Defective Device	3	3
Crack	3	3
Fluid/Blood Leak	3	3
Unstable	3	3
Contamination /Decontamination Problem	2	2
Difficult to Remove	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Connection Problem	2	2
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Material Rupture	1	1
Device Damaged Prior to Use	1	1
Output Problem	1	1
Fracture	1	1
Nonstandard Device	1	1
Suction Problem	1	1
Failure to Deflate	1	1
Pressure Problem	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1331	1333
Insufficient Information	17	17
Air Embolism	6	6
No Consequences Or Impact To Patient	6	6
Arrhythmia	3	3
Vascular Dissection	3	3
Laceration(s)	3	3
Low Blood Pressure/ Hypotension	3	3
Hemorrhage/Blood Loss/Bleeding	2	2
Perforation	1	1
Cardiac Arrest	1	1
Thrombosis/Thrombus	1	1
Perforation of Vessels	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Vascular	II	Apr-13-2022
2	Abbott Vascular Inc	II	Dec-20-2024
3	Boston Scientific Corporation	II	Sep-05-2025