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	153	155
Break	84	84
Physical Resistance/Sticking	46	46
Incorrect, Inadequate or Imprecise Result or Readings	46	46
Device Contamination with Chemical or Other Material	43	43
Inflation Problem	26	26
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	10	10
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
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
Difficult to Open or Remove Packaging Material	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
Suction Problem	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1292	1294
No Consequences Or Impact To Patient	90	90
Insufficient Information	16	16
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