FDA Adverse Event
Malfunction
Summary report: N
AERIS 6 MM X 30 MM LENGTH BALLOON DILATION CATHETER
MDR report key: 13598889
·
Received February 25, 2022
Report
- Report Number
- 13598889
- Event Type
- Malfunction
- Date Received
- February 25, 2022
- Date of Event
- February 7, 2022
- Report Date
- February 11, 2022
- Manufacturer
- BRYAN MEDICAL, INC.
- Product Code
- EOQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PHYSICIAN WAS UTILIZING AIRWAY DILATION BALLOON, WHEN INFLATED TO INFLATED TO 15 ATM (FIRST INFLATION WITHIN THE PATIENT) THE BALLOON POPPED. PHYSICIAN REMOVED AND VISUALIZED THE AREA WITH SCOPES TO ENSURE NO INJURY OR FOREIGN BODIES WITHIN THE PATIENT.
Description of Event or Problem · 0
PHYSICIAN WAS UTILIZING AIRWAY DILATION BALLOON, WHEN INFLATED TO INFLATED TO 15 ATM (FIRST INFLATION WITHIN THE PATIENT) THE BALLOON POPPED. PHYSICIAN REMOVED AND VISUALIZED THE AREA WITH SCOPES TO ENSURE NO INJURY OR FOREIGN BODIES WITHIN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2399093 | AERIS 6 MM X 30 MM LENGTH BALLOON DILATION CATHETER | BRONCHOSCOPE (FLEXIBLE OR RIGID) | EOQ | BRYAN MEDICAL, INC. | KG0630 | 1207127B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 330 DA | Male |