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	980	980
Loose or Intermittent Connection	202	202
Display or Visual Feedback Problem	169	171
Break	86	86
Physical Resistance/Sticking	47	47
Incorrect, Inadequate or Imprecise Result or Readings	47	48
Device Contamination with Chemical or Other Material	44	44
Inflation Problem	31	31
Unsealed Device Packaging	25	25
Packaging Problem	20	20
Deflation Problem	17	17
Material Separation	15	15
Tear, Rip or Hole in Device Packaging	12	12
Improper or Incorrect Procedure or Method	12	12
Detachment of Device or Device Component	10	10
Contamination	9	9
Appropriate Device Problem Term/Code Not Available	8	8
Material Integrity Problem	8	8
Noise, Audible	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Damaged Prior to Receipt by User	6	6
Defective Device	5	5
Product Quality Problem	5	5
Mechanical Problem	5	5
Decoupling	5	5
Difficult to Open or Remove Packaging Material	5	5
Device Contaminated During Manufacture or Shipping	4	4
Crack	4	4
Failure to Zero	4	4
Obstruction of Flow	3	3
Fluid/Blood Leak	3	3
Unstable	3	3
Mechanical Jam	2	2
Connection Problem	2	2
Material Rupture	2	2
Difficult to Remove	2	2
Insufficient Device Problem Information	2	2
Contamination /Decontamination Problem	2	2
Pressure Problem	1	1
Fracture	1	1
Device Damaged Prior to Use	1	1
Material Split, Cut or Torn	1	1
Nonstandard Device	1	1
Material Twisted/Bent	1	1
Failure to Deflate	1	1
Suction Problem	1	1
Output Problem	1	1
Deformation Due to Compressive Stress	1	1
Use of Device Problem	1	1
Retraction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1328	1330
No Consequences Or Impact To Patient	90	90
Insufficient Information	17	17
No Patient Involvement	6	6
Air Embolism	6	6
No Known Impact Or Consequence To Patient	5	5
Low Blood Pressure/ Hypotension	3	3
Arrhythmia	3	3
Cardiac Arrest	3	3
Laceration(s)	3	3
Vascular Dissection	3	3
Hemorrhage/Blood Loss/Bleeding	2	2
Thrombosis/Thrombus	1	1
Perforation	1	1
Perforation of Vessels	1	1
Ventricular Fibrillation	1	1
Bradycardia	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