FDA Adverse Event
Malfunction
Summary report: N
OPTILUME BPH CATHETER SYSTEM
MDR report key: 21633435
·
Received March 18, 2025
Report
- Report Number
- 21633435
- Event Type
- Malfunction
- Date Received
- March 18, 2025
- Date of Event
- February 26, 2025
- Report Date
- March 4, 2025
- Manufacturer
- UROTRONIC INC.
- Product Code
- QXB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE CATHETER WAS INSERTED INTO THE PATIENT. THE CAREGIVER FILLED IT WITH 5CC OF FLUID, AND THE BALLOON ON THE CATHETER POPPED WHILE IN THE PATIENT. THE CATHETER WAS THEN TAKEN OUT AND A NEW SIZE WAS USED. MANUFACTURER RESPONSE FOR UROLOGICAL SURGICAL CATHETERS, LABORIE MEDICAL TECHNOLOGIES (PER SITE REPORTER): SINCE THERE WAS NO SAMPLE AVAILABLE FOR DOCUMENTATION, THEY HAVE OFFERED A REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451933 | OPTILUME BPH CATHETER SYSTEM | DRUG COATED PROSTATIC DILATION CATHETER FOR BENIGN PROSTATIC HYPERPLASIA | QXB | UROTRONIC INC. | 30599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |