FDA Adverse Event
Malfunction
Summary report: N
OPTILUME URETHRAL DRUG COATED BALLOON CATHETER
MDR report key: 22151148
·
Received June 5, 2025
Report
- Report Number
- MW5171112
- Event Type
- Malfunction
- Date Received
- June 5, 2025
- Report Date
- May 29, 2025
- Manufacturer
- URONTRONIC INC
- Product Code
- QRH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
OPTILUME BALLOON POPPED WHEN IN USE FOR SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1401590 | OPTILUME URETHRAL DRUG COATED BALLOON CATHETER | CATHETER, BALLOON, URETHRAL, DRUG-COATED | QRH | URONTRONIC INC | 30 FR X 30MM | 30641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |