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	938	938
Loose or Intermittent Connection	200	200
Display or Visual Feedback Problem	137	139
Break	74	74
Physical Resistance/Sticking	45	45
Incorrect, Inadequate or Imprecise Result or Readings	42	42
Device Contamination with Chemical or Other Material	39	39
Inflation Problem	31	31
Unsealed Device Packaging	23	23
Packaging Problem	17	17
Material Separation	16	16
Deflation Problem	15	15
Improper or Incorrect Procedure or Method	12	12
Tear, Rip or Hole in Device Packaging	11	11
Contamination	11	11
Material Integrity Problem	7	7
Noise, Audible	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Shipping Damage or Problem	6	6
Defective Device	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
Crack	3	3
Detachment of Device or Device Component	3	3
Fluid/Blood Leak	3	3
Unstable	3	3
Difficult to Remove	2	2
Contamination /Decontamination Problem	2	2
Output Problem	2	2
Device Sensing Problem	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Pressure Problem	2	2
Moisture Damage	1	1
Defective Component	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Unintended Movement	1	1
Material Rupture	1	1
Device Damaged Prior to Use	1	1
Low Readings	1	1
Fracture	1	1
Nonstandard Device	1	1
Suction Problem	1	1
Failure to Deflate	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1307	1309
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/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