TPLC - Total Product Life Cycle

• Device: eustachian tube balloon dilation device
• Definition: The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
• Product Code: PNZ
• Regulation Number: 874.4180
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCLARENT, INC.
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	2
ENTELLUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
FIAGON GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	4	4
2018	2	2
2019	1	1
2020	2	2
2021	1	1
2022	3	3
2023	4	4
2024	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8	8
Patient Device Interaction Problem	5	5
Burst Container or Vessel	2	2
Material Rupture	2	2
Unsealed Device Packaging	1	1
Material Fragmentation	1	1
Bent	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Pressure Problem	1	1
Crack	1	1
Product Quality Problem	1	1
Contamination of Device Ingredient or Reagent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	5	5
No Clinical Signs, Symptoms or Conditions	5	5
Discomfort	3	3
Hearing Impairment	2	2
Inflammation	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Syncope/Fainting	1	1
No Information	1	1
Vascular Dissection	1	1
Dizziness	1	1
Itching Sensation	1	1
No Known Impact Or Consequence To Patient	1	1
Unspecified Ear or Labyrinth Problem	1	1
Insufficient Information	1	1
Bradycardia	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1
Tissue Damage	1	1
No Consequences Or Impact To Patient	1	1