FDA Adverse Event
Malfunction
Summary report: N
FLEX VESSEL PREP SYSTEM
MDR report key: 20639460
·
Received November 8, 2024
Report
- Report Number
- 20639460
- Event Type
- Malfunction
- Date Received
- November 8, 2024
- Date of Event
- October 16, 2024
- Report Date
- October 23, 2024
- Manufacturer
- VENTUREMED GROUP, INC.
- Product Code
- PNO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
FLEX VESSEL PREP WAS BEING USED ON THE PATIENT DURING A VENOUS ANGIOPLASTY. AFTER INFLATION, THE SURGEON NOTICED THE BALLOON HAD POPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1815105 | FLEX VESSEL PREP SYSTEM | CATHETER, PERCUTANEOUS, CUTTING/SCORING | PNO | VENTUREMED GROUP, INC. | FSC 4-75 | 63919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |