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	978	978
Loose or Intermittent Connection	202	202
Display or Visual Feedback Problem	157	159
Break	84	84
Physical Resistance/Sticking	46	46
Incorrect, Inadequate or Imprecise Result or Readings	46	46
Device Contamination with Chemical or Other Material	44	44
Inflation Problem	28	28
Unsealed Device Packaging	24	24
Packaging Problem	19	19
Material Separation	16	16
Improper or Incorrect Procedure or Method	12	12
Deflation Problem	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
Shipping Damage or Problem	6	6
Noise, Audible	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Mechanical Problem	5	5
Product Quality 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
Fluid/Blood Leak	3	3
Difficult to Open or Remove Packaging Material	3	3
Unstable	3	3
Obstruction of Flow	3	3
Mechanical Jam	2	2
Output Problem	2	2
Difficult to Remove	2	2
Pressure Problem	2	2
Insufficient Information	2	2
Device Sensing Problem	2	2
Material Rupture	2	2
Connection Problem	2	2
Contamination /Decontamination Problem	2	2
Fracture	1	1
Material Twisted/Bent	1	1
Retraction Problem	1	1
Unintended Movement	1	1
Moisture Damage	1	1
Material Split, Cut or Torn	1	1
Use of Device Problem	1	1
Deformation Due to Compressive Stress	1	1
Suction Problem	1	1
Device Damaged Prior to Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1300	1302
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