FDA Adverse Event
Malfunction
Summary report: N
PROPEL
MDR report key: 23004762
·
Received September 9, 2025
Report
- Report Number
- 23004762
- Event Type
- Malfunction
- Date Received
- September 9, 2025
- Date of Event
- July 17, 2025
- Report Date
- July 30, 2025
- Manufacturer
- INTERSECT ENT
- Product Code
- OWO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DR. [REDACTED] ATTEMPTED TO DEPLOY THE IMPLANT INTO THE PATIENT, AND THE IMPLANT DID NOT DEPLOY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2836093 | PROPEL | DRUG-ELUTING SINUS STENT | OWO | INTERSECT ENT | 60011 | 24070801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |