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	979	979
Loose or Intermittent Connection	202	202
Display or Visual Feedback Problem	162	164
Break	84	84
Physical Resistance/Sticking	47	47
Incorrect, Inadequate or Imprecise Result or Readings	46	46
Device Contamination with Chemical or Other Material	45	45
Inflation Problem	32	32
Unsealed Device Packaging	24	24
Packaging Problem	19	19
Material Separation	16	16
Deflation Problem	16	16
Improper or Incorrect Procedure or Method	12	12
Tear, Rip or Hole in Device Packaging	11	11
Contamination	11	11
Appropriate Term/Code Not Available	8	8
Material Integrity Problem	8	8
Defective Device	7	7
Noise, Audible	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Shipping Damage or Problem	6	6
Product Quality Problem	5	5
Difficult to Open or Remove Packaging Material	5	5
Mechanical Problem	5	5
Device Contaminated During Manufacture or Shipping	5	5
Failure to Zero	4	4
Crack	4	4
Detachment of Device or Device Component	4	4
Obstruction of Flow	3	3
Fluid/Blood Leak	3	3
Unstable	3	3
Difficult to Remove	2	2
Contamination /Decontamination Problem	2	2
Insufficient Information	2	2
Material Rupture	2	2
Output Problem	2	2
Device Sensing Problem	2	2
Connection Problem	2	2
Pressure Problem	2	2
Mechanical Jam	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
Device Damaged Prior to Use	1	1
Retraction Problem	1	1
Low Readings	1	1
Fracture	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1310	1312
No Consequences Or Impact To Patient	90	90
Insufficient Information	17	17
Air Embolism	6	6
No Patient Involvement	6	6
No Known Impact Or Consequence To Patient	5	5
Arrhythmia	3	3
Vascular Dissection	3	3
Cardiac Arrest	3	3
Laceration(s)	3	3
Low Blood Pressure/ Hypotension	3	3
Hemorrhage/Bleeding	2	2
Perforation	1	1
Ventricular Fibrillation	1	1
Thrombosis/Thrombus	1	1
Bradycardia	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